I-Byte Healthcare July 2021

IT Shades
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I-Bytes
Healthcare
July Edition 2021
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Table of Contents
1. Financial, M & A Updates..................................................................................................................................1
2. Solution Updates.................................................................................................................................................9
3. Rewards & Recognition Updates.....................................................................................................................21
4. Customer Success Updates...............................................................................................................................32
5. Partnership Ecosystem Updates......................................................................................................................40
6. Environment & Social Updates.......................................................................................................................66

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Financial, M & A
Updates Healthcare Industry

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Financial, M&A Updates
IT Shades
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AbbVie (USA) Exercises Right to Acquire TeneoOne and Lead Asset TNB-383B for
the Potential Treatment of Relapsed or Refractory Multiple Myeloma
AbbVie and Teneobio, Inc. announced that AbbVie exercised its exclusive right to
acquire TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a
BCMA-targeting immunotherapeutic for the potential treatment of relapsed or
refractory multiple myeloma (R/R MM). In February 2019, AbbVie and
TeneoOne entered a strategic transaction to develop and commercialize
TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3
and is designed to direct the body's own immune system to target and kill
BCMA-expressing tumor cells. AbbVie exercised its exclusive right to acquire
TeneoOne and TNB-383B based on an interim analysis of an ongoing Phase 1
study. Interim results from the ongoing Phase 1 study demonstrated an objective
response rate (ORR) of 79 percent, very good partial response (VGPR) or better
of 63 percent, and complete response (CR) of 29 percent at doses ≥40 mg in the
dose escalation cohorts with a median follow-up time of 6.1 months (n=24). The
median duration of response has not been reached.
Executive Commentary
"Since the beginning of this partnership, we have been encouraged by the
potential of TNB-383B as a promising new therapy for multiple myeloma,
and our analysis of the Phase 1 data to date has allowed us to make this
decision with confidence," said M.D., vice chairman and president, AbbVie.
"While other BCMA and CD3 bispecific therapies require weekly
administration, the recommended Phase 2 dose of TNB-383B will investigate
infrequent dosing of every 3 weeks for intravenous administration, which is
an important treatment factor for people living with multiple myeloma."
Description
1

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Abiomed (USA) Acquires preCARDIA, a Breakthrough Medical Device Company,
to Improve Outcomes for Heart Failure Patients
Abiomed has acquired preCARDIA, developer of a proprietary catheter
and controller that will complement Abiomed’s product portfolio to
expand options for patients with acute decompensated heart failure
(ADHF). The preCARDIA system is uniquely designed to rapidly treat
ADHF-related volume overload by effectively reducing cardiac filling
pressures and promoting decongestion to improve overall cardiac and
renal function. Annually, more than one million patients are admitted to
hospitals in the United States with ADHF. Despite available
pharmaceutical treatments, heart failure is the leading cause of
hospitalization in patients older than 65 years of age. preCARDIA
provides heart failure specialists a minimally invasive solution with the
potential to improve patient outcomes and lower the cost of care by
providing early intervention with this new technology.
“Abiomed, with its mission of resting and recovering hearts, is
uniquely positioned to build on the legacy of what we started,” said
president and chief executive officer at preCARDIA. “I am confident
that the addition of our technology into Abiomed’s product portfolio
will further improve outcomes for heart failure patients.”
Description
2

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IT Shades
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AbbVie (USA) Exercises Right to Acquire TeneoOne and Lead Asset TNB-383B for
the Potential Treatment of Relapsed or Refractory Multiple Myeloma
AbbVie and Teneobio, Inc. announced that AbbVie exercised its exclusive right to
acquire TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a
BCMA-targeting immunotherapeutic for the potential treatment of relapsed or
refractory multiple myeloma (R/R MM). In February 2019, AbbVie and
TeneoOne entered a strategic transaction to develop and commercialize
TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3
and is designed to direct the body's own immune system to target and kill
BCMA-expressing tumor cells. AbbVie exercised its exclusive right to acquire
TeneoOne and TNB-383B based on an interim analysis of an ongoing Phase 1
study. Interim results from the ongoing Phase 1 study demonstrated an objective
response rate (ORR) of 79 percent, very good partial response (VGPR) or better
of 63 percent, and complete response (CR) of 29 percent at doses ≥40 mg in the
dose escalation cohorts with a median follow-up time of 6.1 months (n=24). The
median duration of response (DOR) has not been reached.
"Since the beginning of this partnership, we have been encouraged by the
potential of TNB-383B as a promising new therapy for multiple myeloma,
and our analysis of the Phase 1 data to date has allowed us to make this
decision with confidence," said M.D., vice chairman and president, AbbVie.
"While other BCMA and CD3 bispecific therapies require weekly
administration, the recommended Phase 2 dose of TNB-383B will investigate
infrequent dosing of every 3 weeks for intravenous administration, which is
an important treatment factor for people living with multiple myeloma."
Description
3

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AmerisourceBergen (USA) Completes Acquisition of Alliance Healthcare Businesses
AmerisourceBergen Corporation announced the completion of its
acquisition of the majority of Walgreens Boots Alliance’s Alliance
Healthcare businesses for $6.275 billion in cash, subject to a customary
working capital and net debt adjustment, and 2 million shares of
AmerisourceBergen common stock. AmerisourceBergen and Walgreens
Boots Alliance will also execute on the expansion and extension of
commercial agreements in order to drive incremental growth and
synergies.
“We are excited to complete the acquisition and extend a warm
welcome to the talented team at Alliance Healthcare,” said Chairman,
President and Chief Executive Officer of AmerisourceBergen. “The
acquisition of Alliance Healthcare expands our reach and solutions in
pharmaceutical distribution and adds to AmerisourceBergen’s
breadth and depth of global manufacturer services. With Alliance
Healthcare, we will advance our ability to provide innovative and
global healthcare solutions and further our purpose of being united in
our responsibility to create healthier futures.”
Description
4

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Anthem (USA), Inc. Completes Acquisition of MMM Holdings, LLC and Affiliates
From InnovaCare Health, L.P.
Anthem, Inc. announced the completion of the acquisition of Puerto
Rico-based MMM Holdings, LLC and its Medicare Advantage (MA)
plan MMM Healthcare, LLC. as well as affiliated companies and
Medicaid plan. Anthem acquired MMM from InnovaCare Health, L.P., a
leading integrated, value-based payor and provider service organization.
With more than 275,000 MA members and over 314,000 Medicaid
members, MMM is the ninth-largest MA plan in the country and Puerto
Rico’s second-largest Medicaid plan. MMM is the island’s largest MA
plan and one of the fastest-growing vertically integrated healthcare
organizations in the United States.
“We are pleased to officially bring MMM into the Anthem family
because we share a commitment to being a lifetime partner in health
to the people we serve,” said EVP and President, Government
Business Division for Anthem, Inc. “Our whole-person approach to
health, which includes addressing the social drivers of health, gives
Medicare and Medicaid-eligible individuals access to the services and
care they need to improve their health and wellbeing.”
Description
5

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Lilly (USA) Announces Acquisition of Protomer Technologies
Eli Lilly and Company announced the acquisition of Protomer Technologies a private
biotech company. Protomer's proprietary peptide- and protein-engineering platform
is used to identify and synthesize molecules that can sense glucose or other
endogenous modulators of protein activity. The potential value of the transaction is
over $1 billion, with successful achievement of future development and commercial
milestones. Lilly previously led an equity investment in Protomer alongside the
JDRF T1D Fund, providing Lilly with 14 percent ownership of the company. Lilly is
acquiring the remainder of the stock of Protomer beyond its initial investment.
Founded in 2015 and based in Pasadena, California, Protomer is engineering
next-generation protein therapeutics that can sense molecular activators in the body.
The company's proprietary chemical biology-based platform enables the
development of therapeutic peptides and proteins with tunable activity that can be
controlled using small molecules. Protomer has used this approach toward advancing
a portfolio of therapeutic candidates, including glucose-responsive insulins that can
sense sugar levels in the blood and automatically activate as needed throughout the
day.
"Lilly has long strived to make life better for people living with diabetes and we
have a continued determination to provide real solutions, including innovation in
insulin therapy. Glucose-sensing insulin is the next frontier and has the potential
to revolutionize the treatment and quality of life of people with diabetes by
dramatically improving both therapeutic efficacy and safety of insulin therapy,"
said vice president, diabetes research and clinical investigation at Lilly.
"Protomer's glucose-sensing insulin program, based on its proprietary molecular
engineering of protein sensors (MEPS) platform, is showing significant promise
and Lilly is excited to enhance our diabetes pipeline with the company's
innovative technology."
Description
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Henry Schein (USA) Acquires Majority Interest in eAssist Dental Solutions
Henry Schein, Inc. the world’s largest provider of health care solutions to
office-based dental and medical practitioners, announced that it has acquired a
70% ownership position in eAssist Dental Solutions (eAssist), the developer
of a leading and fast-growing virtual dental billing outsourcing service that
will advance the Company's mission to offer best-of-breed solutions to help
dental practices operate more efficiently and profitably, freeing up practice
resources to focus on patient care. Headquartered in American Fork, UT,
eAssist was founded in 2011 by James Anderson, DMD, and Sandy Odle to
assist with billing challenges in his dental practices. Dr. Anderson will
continue to manage the eAssist business as Chief Executive Officer, along
with the current eAssist management team. In 2020, eAssist had sales of
approximately $31 million. Henry Schein expects that eAssist will be slightly
dilutive to the Company’s 2021 financial results and to be accretive thereafter.
Financial terms were not disclosed.
“Henry Schein has a long-standing commitment to supporting dental
practice growth, efficiency, and profitability through our comprehensive
offering of solutions,” said Chairman of the Board and Chief Executive
Officer of Henry Schein. “We are delighted to add eAssist to our leading
portfolio of value-added services, which will help our customers improve
their critical insurance and billing functions so dental teams can focus on
delivering quality patient care. We welcome our new colleagues to Team
Schein and look forward to continued success together.”
Description
7

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IDEXX (USA) Acquires ezyVet
IDEXX Laboratories, Inc. a global leader in veterinary diagnostics
and software, announced the acquisition of ezyVet®, a fast-growing,
innovative practice information management system (PIMS). With the
acquisition, IDEXX further expands its world-class cloud software
offerings that support customers with technology solutions that raise
the standard of care for patients, improve practice efficiency, and
enable more effective communication with pet owners.
“ezyVet is a truly impressive cloud-native software solution that
continues to transform the industry and the software experience for
veterinary practitioners. Their growth has been very strong, but the
true testament to what they’ve created is their industry-leading
customer satisfaction,” said Jay Mazelsky, IDEXX President and
Chief Executive Officer. “We greatly admire the way ezyVet
enables veterinarians to focus on what matters most: caring for
patients and growing their business. We are pleased to welcome
ezyVet to the IDEXX family and look forward to bringing this
platform into the IDEXX customer community.”
Description
8

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Solutions Updates
Healthcare Industry

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Solution Updates
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Align Technology (USA) Releases Itero Workflow 2.0 Software and Previews
New Itero Element 5d Imaging System Auto-Upload Functionality
9
Solution Description
Align Technology, Inc. a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners,
and exocad CAD/CAM software for digital orthodontics and restorative dentistry, announced the new iTero Workflow 2.0 software release with advanced features that
provide enhanced intraoral image sharpness for clearer hard and soft tissue details to aid in treatment diagnosis, while also driving practice efficiency, patient
engagement, and a more seamless end-to-end digital treatment experience for doctors and their patients. The newly released iTero Workflow 2.0 software features
include:
• Faster scanning: Enables a faster and smoother all-in-one scan for maximum efficiency with 20% less waiting for processing time on the iTero Element Plus Series
scanners1 and 50% faster movement and 25% faster rotation during scanning2 for efficient daily use and ease of learning on all iTero Element scanners.
• Improved visualization: The integrated 3D intraoral camera included in the iTero Element 5D Plus imaging system provides enhanced sharpness and improved image
quality powered by advanced AI capabilities to deliver clearer soft and hard tissue details to support diagnosis3. In addition, the enhanced capabilities allow clinics to
efficiently use intraoral scan images in place of traditional intraoral photos as they can capture multiple intraoral images at different angles automatically with one scan.
• Next level patient communication tools: The new Snapshot tool and iTero Scan Report provide doctors and their staff with the ability to capture information such as
Invisalign Outcome Simulator projections and share it digitally with their patients, allowing patients to make more confident decisions – in the dental chair or at home –
which may lead to higher treatment acceptance.

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Solution Updates
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Eisai (Japan) Launches In-House Developed Anti-Insomnia Drug Dayvigo®
(Lemborexant) In Hong Kong
10
Eisai Co., Ltd. announced that its Hong Kong subsidiary Eisai Co., Ltd. has launched the in-house-discovered and developed orexin receptor antagonist DAYVIGO® for the
treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai received approval for DAYVIGO in Hong Kong on February
28, 2021, and this launch is the first for DAYVIGO in Asia outside of Japan. DAYVIGO is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating
sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). DAYVIGO acts on the orexin neurotransmitter system and is believed
to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythm. DAYVIGO binds to orexin receptors OX1R and OX2R and acts as a competitive
antagonist with stronger inhibition effect on OX2R, which suppresses both REM and non-REM sleep drive, such that DAYVIGO may provide faster sleep onset and better sleep
maintenance to patients. DAYVIGO was launched in the U.S. and Canada for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or
sleep maintenance and in Japan for the treatment of insomnia. In addition, applications for approval have been submitted to the respective regulatory authorities in Australia,
Brazil, India, Indonesia, Malaysia, the Philippines, Singapore, Taiwan and Thailand, and Eisai plans to further expand submissions of applications for approval in other
countries. Insomnia is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, that can lead to daytime consequences, such
as fatigue, difficulty concentrating and irritability.1,2 Insomnia is one of the most common sleep-wake disorders. It is estimated that approximately 30% of adults worldwide
have symptoms of insomnia.3,4 In Hong Kong, over 35% of adults are reported to have symptoms of insomnia.5 In particular, older adults also have a higher prevalence rate
with many experiencing insomnia symptoms for months to years. As a result, insomnia causes various social losses, such as long absences and reduced productivity. It can
increase the risk of falls in older adults.

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Eisai (Japan) and Biogen Inc. Announce U.S. Fda Grants Breakthough
Therapy Designation For Lecanemab (Ban2401)
11
Eisai Co., Ltd. and Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy
designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s
disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for
serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an
efficient development program as well as eligibility for rolling review and potentially priority review. The FDA’s Breakthrough Therapy
designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild
cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201
explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline. In this study, pre-specified
analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses. This release
discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no
guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

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Biogen and Eisai (Japan) launch multiple initiatives to help patients with
Alzheimer’s disease access ADUHELMTM
12
Following U.S. Food and Drug Administration’s (FDA) accelerated approval of ADUHELMTM as the first and only Alzheimer’s disease treatment to address a
defining pathology of the disease by reducing amyloid beta plaques in the brain, Biogen (Nasdaq: BIIB) and Eisai Inc., U.S. subsidiary of Eisai Co., Ltd.,
announced a range of programs intended to support access for all qualified patients, including traditionally underserved populations. These initiatives aim to help
patients and their families understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment. Personal Biogen Support
Service Coordinators are now available to patients and their families to provide one-on-one support. The service coordinators can answer questions about
Alzheimer’s disease and ADUHELM treatment, assess financial assistance options for eligible patients, and locate healthcare providers and infusion sites, among
other topics. Biogen and Eisai are committed to addressing health equity for underserved and underrepresented populations that are at higher risk for Alzheimer’s
disease. Black/African Americans and Latinx people are disproportionally more likely to develop Alzheimer’s disease as well as more likely to have missed
diagnoses compared to non-Hispanic white Americans. The ethnically diverse population of U.S. veterans also faces increased risk for the disease as a result of
their service, including conditions such as post-traumatic stress disorder, traumatic brain injury, and other factors. With the Veterans Health Administration (VHA),
Biogen is working to finalize a multi-year agreement in order to support access for veterans throughout the VHA system. The VHA is the largest integrated health
system in the U.S., with nine million enrolled veterans, approximately 48 percent of which are over the age of 65.

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Grifols (Spain) to provide Korean Red Cross with Procleix Panther for
blood screening, extending donor testing leadership in Asia
13
Grifols a global leader in the development of plasma-derived therapies and innovative diagnostic solutions, announced it will provide
the Korean Red Cross (KRC) with its industry-leading Procleix Panther System running nucleic acid testing (NAT) technology to
help ensure the safety of South Korea’s blood supply. As part of the KRC contract, Grifols will deliver 28 Procleix Panther Systems
that will be deployed during the following months across the humanitarian organization’s three laboratory sites in South Korea. When
fully operational, they will test about 94% of the country’s blood donations, which are needed mostly for transfusions. The Procleix
Panther Systems are known for their reliability, scalability and versatility, providing high throughput with a small footprint while
streamlining laboratory workflow. They will feature the Procleix Ultrio Elite Assay, a high-specificity NAT designed to improve
blood safety by detecting the potential existence of the most important infectious pathogens in a single, simultaneous test from human
serum or plasma. Grifols has steadily increased its transfusion safety leadership in Asia-Pacific, where it currently screens more than
half of all blood donations, including 100% of those in Australia, Japan, Malaysia and New Zealand.

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Johnson & Johnson (USA) Launches Network of Global Health Discovery
Centers that Aim to Speed Up Science and Tackle Pandemic Threats
14
Johnson & Johnson announced the launch of the J&J Centers for Global Health Discovery (J&J Centers), a new, global network of unique research partnerships
that will leverage the institutional strengths of Johnson & Johnson and leading academic institutions to accelerate discovery research to address the world’s most
pressing global health challenges. The first J&J Satellite Center for Global Health Discovery (Satellite Center) was launched at the London School of Hygiene &
Tropical Medicine (LSHTM) at an event co-hosted by Johnson & Johnson and LSHTM, and additional J&J Centers will launch worldwide through 2022. The J&J
Centers will advance the critical, early-stage discovery and exploratory science needed to develop potentially lifesaving innovations to address diseases that
disproportionately impact the world’s poorest and most vulnerable people. Each Satellite Center will focus on entrenched and emerging threats that are pressing
and have a high unmet need, including tuberculosis (TB), dengue fever, flavivirus, coronavirus and antimicrobial resistance (AMR). The Centers help stimulate
funding for early stage science, innovation and talent development, areas that are traditionally under-funded. A 2018 analysis found that many innovations and
technologies needed to fight some of the world’s most prevalent health threats are not likely to be developed, due in part to significant funding and innovation gaps.
The J&J Centers aim to stimulate the Company’s research and development (R&D) pipeline at the discovery stage by focusing on funding early-stage science,
innovation and talent development. The J&J Centers help address the dual innovation and health equity gap by creating a larger and decentralized scientific
network that empowers scientists worldwide to drive R&D in the communities where the need is greatest. By joining forces with other institutions and leveraging
their regional networks, the J&J Centers will help mentor talent and advance the science needed as efficiently as possible.

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Smith+Nephew (UK) launches Real Intelligence and CORI◊ Surgical System,
next generation robotics platform, in Australia and New Zealand
15
Smith+Nephew the global medical technology business, announces the launch of its Real Intelligence suite of enabling technology
solutions including its next generation robotics platform, the CORI Surgical System, in Australia and New Zealand. Demand for
robotic-assisted surgery for large joints in Asia-Pacific is forecast to grow (27.3% between 2017 to 2027).1 In Australia alone, leading
technologies, including robotics, are already utilized in nearly 50% of all total knee procedures2 - a market with approximately
57,000 total knee arthroplasty and 3,700 unicompartmental procedures per year.2The CORI Surgical System is small, portable, and
designed for crowded operating rooms.3 It includes new camera technology that is over four times faster, offers more efficient cutting
with twice the volume*3, and aims to deliver a faster cutting time. The CORI System uses surgeon-controlled robotics, and its
modular design will enable it to be scaled across the orthopaedic service line. The benefits of robotics-assisted surgery for patients
are myriad, and include significantly improved patient reported outcome measures and shortened length of hospital stay5‡, where a
study has shown an earlier return to an active lifestyle4‡π. The CORI Surgical System was first launched in the US during 2020 and
has expanded in other global markets for both total and unicompartmental knee arthroplasty applications.

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Smith+ Nephew (UK) launches Real Intelligence and CORI◊ Surgical
System, next generation robotics platform, in India
16
Smith+Nephew the global medical technology business, announces the launch of its Real Intelligence suite of enabling technology solutions
including its next generation robotics platform, the CORI Surgical System, in India. Robotics-assisted orthopaedic surgery has been gaining
momentum in India, which is expected to grow at 20% Compound Annual Growth Rate over the coming years1 as surgeons and patients look
to better and more predictable outcomes. With around 200,000 joint replacement procedures annually2, the need exists and the opportunity is
well-timed to introduce a ground-breaking new technology. Smith+Nephew first brought a robotic-assisted solution to India in 2016 with its
NAVIO◊ Surgical System, recently awarded the ‘Best Healthcare Brand in India’ by the Economic Times. Since then, the NAVIO installed
base has steadily grown, with multiple installations across the 12 states. The CORI Surgical System was first launched in the US during 2020
and has expanded in other global markets for both total and unicompartmental knee arthroplasty applications. The CORI Surgical System is
small*,4, portable and perfect for crowded operating rooms4. It includes new camera technology that is over four times faster**,4, offers more
efficient cutting with twice the volume**,4, and aims to deliver a faster* robotic-assisted surgical procedure.5 The CORI System uses
surgeon-controlled robotics, and its modular design will enable it to be scaled across the orthopaedic service line.

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Thermo Fisher (USA) Scientific Launches Ion AmpliSeq SARS-CoV-2
Insight Research Assay for SARS-CoV-2 Surveillance
17
Thermo Fisher Scientific introduced the Ion AmpliSeq SARS-CoV-2 Insight Research Assay to improve SARS-CoV-2 surveillance.
The assay is designed to enable early identification of new and known variants from samples that have lower viral loads. By
sequencing more than 99 percent of the SARS-CoV-2 genome, the assay covers all potential serotypes. The new Ion AmpliSeq
SARS-CoV-2 Insight Research Assay broadens and improves local, regional and national surveillance efforts to discover emerging
SARS-CoV-2 variants through highly sensitive next-generation sequencing (NGS). Combined with Thermo Fisher's NGS
technology, the panel enables researchers to obtain epidemiological insights with rapid turn-around time, workflow automation and
seamless informatics and data uploading to public SARS-CoV-2 data repositories. Optimized to run on the Ion GeneStudio S5
System,* the assay includes 237 amplicons specific to SARS-CoV-2, with the addition of variant-tolerant primers for emerging
variants. The increased sensitivity of this assay will empower researchers to sequence the complete genome and discover new
variants from a variety of sample types including nasophyrengeal and shallow nasal swabs, saliva and others, and with cycle
threshold (Ct) values higher than 28, or as low as 50 viral copies.

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Thermo Fisher (USA) Scientific Launches CE-IVD-Marked Next-Generation
TaqPath COVID-19 2.0 Test
18
Thermo Fisher Scientific, the world leader in serving science, announced the launch of a new CE-IVD-marked COVID-19
test. The TaqPath COVID-19 Fast PCR Combo Kit 2.0. expands Thermo Fisher's menu of highly accurate tests that detect
active SARS-CoV-2 infections. The kit uses an advanced assay design which compensates for current and emerging
variants by using eight total targets across three genomic regions of the virus. This approach helps to ensure the test
provides accurate results even as the virus that causes COVID-19 continues to mutate. The TaqPath COVID-19 Fast PCR
Combo Kit 2.0 test assesses raw saliva directly with a turnaround time of two hours to enable widespread, high-frequency
testing. The first generation TaqPath COVID-19 CE-IVD RT PCR Kit and the TaqPath COVID-19 Combo Kit, which use
a different assay design, respectively, received initial CE-IVD certification and Emergency Use Authorization from the
U.S. Food and Drug Administration (FDA) in March 2020.

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Thermo Fisher (USA) Scientific and UC Davis Launch Center of Excellence
in Clinical Metabolomics
19
Thermo Fisher Scientific the world leader in serving science, and the University of California, Davis (UC Davis) West Coast Metabolomics Center
announced The Center of Excellence in Clinical Metabolomics, a research collaboration to provide the metabolomics community with innovations, best
practices and standard operating procedures to support the rapid scale-up of large cohort studies and clinical research. Metabolomics is an increasingly
important field where researchers identify diagnostic biomarkers for disease, discover new drug targets, develop tools to predict drug response, and enable
precision medicine overall. Advancements in this area can help ensure that patients receive more targeted medicines and increase the likelihood those
therapies will achieve their intended outcomes. The Center of Excellence in Clinical Metabolomics, based on the UC Davis Sacramento campus, will enable
targeted and untargeted metabolic profiling for large-scale population-based cohorts across translational research and precision medicine. The Center will
develop standardized processes for the research community, including end-to-end metabolic profiling workflows optimized liquid chromatography-mass
spectrometry (LC-MS) methods, protocols for analytical controls to monitor instrument performance and training courses for metabolomics staff, scientists
and core lab managers. As part of the collaboration, Thermo Fisher is providing its powerful Orbitrap technology. The Center will generate high-quality data
using the latest generation of Orbitrap-based mass spectrometers in conjunction with the Thermo Scientific Vanquish Duo UHPLC system for increased
throughput. This instrument combination will support the development of streamlined workflows for large-scale studies and translational research.

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Thermo Fisher (USA) Scientific and UC Davis Launch Center of Excellence
in Clinical Metabolomics
20
Thermo Fisher Scientific the world leader in serving science, and the University of California, Davis (UC Davis) West Coast Metabolomics Center
announced The Center of Excellence in Clinical Metabolomics, a research collaboration to provide the metabolomics community with innovations, best
practices and standard operating procedures to support the rapid scale-up of large cohort studies and clinical research. Metabolomics is an increasingly
important field where researchers identify diagnostic biomarkers for disease, discover new drug targets, develop tools to predict drug response, and enable
precision medicine overall. Advancements in this area can help ensure that patients receive more targeted medicines and increase the likelihood those
therapies will achieve their intended outcomes. The Center of Excellence in Clinical Metabolomics, based on the UC Davis Sacramento campus, will enable
targeted and untargeted metabolic profiling for large-scale population-based cohorts across translational research and precision medicine. The Center will
develop standardized processes for the research community; including end-to-end metabolic profiling workflows optimized liquid chromatography-mass
spectrometry (LC-MS) methods, protocols for analytical controls to monitor instrument performance and training courses for metabolomics staff, scientists
and core lab managers. As part of the collaboration, Thermo Fisher is providing its powerful Orbitrap technology. The Center will generate high-quality data
using the latest generation of Orbitrap-based mass spectrometers in conjunction with the Thermo Scientific Vanquish Duo UHPLC system for increased
throughput. This instrument combination will support the development of streamlined workflows for large-scale studies and translational research.

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AmerisourceBergen (USA) Recognized as One of the 50 Most
Community-Minded Employers in the Greater Philadelphia Region
21
AmerisourceBergen, a global healthcare company, has been named a 2021 honoree of The Civic 50 Greater Philadelphia by the
Philadelphia Foundation in partnership with Points of Light and local partners. Modeled after Points of Light’s national program, The
Civic 50 Greater Philadelphia provides a standard for corporate citizenship and showcases how employers use their time, skills, and
resources to drive social impact in their communities and company. In 2020, AmerisourceBergen donated nearly $2 million in
corporate giving to global non-profits and community-based organizations, many supporting efforts to promote social justice and
health equity. The AmerisourceBergen Foundation, an independent, not-for-profit charitable giving organization, also made nearly
$10 million in donations to 100+ organizations, including more than $1 million to COVID-19 specific funding, which was deployed
to regional, national and global organizations focused on combatting the economic, psychosocial and health challenges resulting from
the pandemic. More information is available in AmerisourceBergen’s 2020 Global Sustainability Report, which shares progress and
impact on its environmental, social, and governance (ESG) priorities, and details the positive effects of its community efforts.
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Astellas (Japan) Named to FTSE4Good Index Series for 10 Consecutive
Years
22
Astellas Pharma Inc. announced that it has been named to the FTSE4Good Index Series for 10 consecutive years, as a company that is
performing excellent initiatives in the areas of ESG [environmental (E), social (S), governance (G)]. Astellas has conducted various
activities based on the thought that Astellas’ contribution to the sustainability of society means the realization its philosophy. These
sustained activities led Astellas to recognize and to be selected in such for a decade. Astellas has set "Deepen our Engagement in
Sustainability" as one of its new strategic goals in its Corporate Strategic Plan 2021*2. In addition to implementing "Value Protection"
which is an initiative to comply with regulations and meet the requirements from the global society, Astellas will further strengthen
"Value Creation" activities to provide its patients’ access to innovative therapeutics and take proactive measures to conserve the global
environment. Besides the FTSE4Good Index Series, Astellas also has been named to all ESG investment indices selected by the
Government Pension Investment Fund of Japan. These are the FTSE Blossom Japan Index, the MSCI Japan ESG Select Leaders Index,
the MSCI Japan Empowering Women Index (WIN), and the S&P/JPX Carbon Efficient Index. Astellas will continue to work under its
basic policy of sustainability, which is to improve the sustainability of both the global society and Astellas while keeping ESG in mind.
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Cardinal Health (USA) recognized as a “Best Company for Multicultural
Women”
23
Cardinal Health has been named one of the 2021 Best Companies for Multicultural Women by Seramount an honor
recognizing companies that create and use best practices in hiring, retaining and promoting multicultural women in the
United States. The full 2021 list can be found here. Since 2003, Seramount’s Best Companies for Multicultural Women
has tracked corporations’ progress in creating cultures that encourage multicultural women to join and rise through the
ranks. Participation in Seramount’s initiative is up 19% year over year, and over the last five years, it has increased by
358%. Seramount’s Insights team attributes the uptick to increased interest in hiring and promoting women of color as
well as improvement in the types of questions asked, especially the specific evaluation of women at each level by
individual race and ethnicity, and the introduction of questions on anti-racism efforts.
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Centene (USA) Announces Winners Of Youth Impact Award For Vaping
Prevention
24
Centene Corporation has announced the winners of the Centene Institute Youth Impact Award for Vaping Prevention. The
national program is a curriculum and contest for adolescents ages 14 through 19 to raise awareness about vaping, e-cigarette use
and prevention. The three national winners from Ohio, Georgia and New Jersey were recognized for their exceptional work and
received awards during a virtual ceremony on June 14, 2021. The winning submission from Ohio can be viewed here. The contest
challenged youth to take action by developing and submitting a 30 to 60-second Public Service Announcement (PSA) video to
educate their peers about the dangers of vaping. The contest accepted submissions from January 19 through April 16, 2021.
During that time, Centene received over 150 entries across 30 states. The winning submissions were evaluated by judges based
on the effectiveness of the message, originality and production quality. In December 2018, the U.S. Surgeon General declared
youth vaping a public health epidemic. The COVID-19 pandemic has further complicated e-cigarette use in adolescents. Recent
research suggests that youth who vape and use e-cigarettes have an elevated risk for COVID-19 infection.
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CVS Health (USA) News and Aetna Foundation release 2021 Healthiest
Communities rankings
25
U.S. News & World Report, in collaboration with the Aetna Foundation, an independent, charitable and philanthropic affiliate of CVS Health,
released the fourth annual Healthiest Communities rankings. This year’s rankings are accompanied by tools highlighting county-level COVID-19
vaccine rates and other pandemic data, as well as editorial explorations of equity and mental health — key components that can shape overall
health and well-being. In the 2021 rankings, the top five Healthiest Communities score above the national average in at least eight of the 10
categories used in the analysis, including Los Alamos County, New Mexico — the first community to repeat as No. 1 since the launch of the
Healthiest Communities rankings in 2018. In the 2021 rankings, the County posted its highest scores in the Housing, Population Health and
Infrastructure categories. Douglas County, Colorado, came in at No. 2, followed by Falls Church, Virginia, at No. 3. Loudoun County, Virginia,
moved to No. 4, and Broomfield County, Colorado, rounded out the list at No. 5. The 2021 rankings are accompanied by editorial pieces exploring,
for example, connections between community vaccine data and other health-related metrics. The U.S. News editorial team also examines issues
of equity around Hennepin County, Minnesota — a top 500 county that was the site of George Floyd’s murder by a police officer in May 2020 —
and of mental health in Hawaii, where Honolulu County posted the country’s highest score in that subcategory of the rankings.
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Eisai (Japan) Receives Special Prize at Platinum Career Award 2021
26
Eisai Co., Ltd. announced that it has received a special prize at the Platinum Career Award 2021. The awards ceremony was held via online
at the symposium on June 8, 2021. Eisai will enhance the development of self-reliant talents, so that each and every employee who
sympathizes with its corporate philosophy can adapt themselves to any changes and contribute to the creation of new social value through
working independently with high motivation. By promoting work and learning style reforms to achieve this goal, Eisai attempts to transition
from a company-led career development style to a proactive career development style based on the diversity of values of individual employees
and their willingness to take on challenges. In addition, Eisai will work on expanding the range of individual discretion in choosing work
locations and working hours, as well as implementing new measures for utilizing IT tools in terms of both hardware and software, such as
efficiently providing training opportunities for all employees to independently learn new skills and acquire new working experiences,
adopting a special paid leave system that can be used for self-development and social contribution activities, and promoting online dialogue
between members inside and outside the organization. Eisai will make continuous efforts based on the hhc philosophy to further contribute to
increasing the benefits of patients and their families around the world.
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Lilly (USA) announces call for Leonard Award nominations as part of
global initiative celebrating 100 years of insulin
27
In honor of the 100th anniversary of the discovery of insulin, Eli Lilly and Company launched the Leonard Award to recognize diverse champions dedicated to
advancing diabetes management through innovative thinking and novel approaches. Nominations are being accepted now until August 31, 2021 at
Lilly.com/LeonardAward. The Leonard Award is inspired by the life of Leonard Thompson, the first person with diabetes to be treated with insulin in 1922, and
looks to celebrate ongoing achievements in the diabetes community. The Award is open to eligible participants from the following categories:
• Teen/young adult: 18- to 25-year-old living with diabetes or with a strong personal connection to someone impacted by diabetes
• Advocate/advocacy professional: Active advocate for people with diabetes, either through personal channels or with an established organization
• Endocrinologist/primary care physician: Health care professional specializing in endocrinology or who acts as a primary care physician to people with diabetes
• Diabetes educator/nurse: Diabetes educator and/or nurse specializing in the care of people with diabetes
• Researcher: Research professional dedicated to research in the field of diabetes care (therapeutics, technology or otherwise)
Five winners – one from each category – will be selected, and Lilly will give $20,000 in recognition of each winner ($100,000) to Life for a Child, a non-profit
organization that provides access to care, education, and lifesaving medicines and supplies to children and young people with type 1 diabetes in less-resourced
countries.
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McKesson (USA) Named One of the Best Places to Work for Disability
Inclusion
28
McKesson is honored as one of the “Best Places to Work for Disability Inclusion” by Disability Equality Index (DEI).
McKesson also earned a top score of 100% for displaying best-in-class commitments to culture and leadership,
accessibility, strong employment practices, community engagement and supplier diversity. Launched in 2015, the DEI is
acknowledged as the most robust disability inclusion assessment tool and has become a nationally recognized
benchmarking report for businesses to gauge their level of workplace inclusion. The DEI is based on an annual survey that
measures an organization’s adoption of inclusive policies and practices for people with disabilities. McKesson continues
to build on its inclusion and diversity efforts and has been named a “Military Friendly Employer” by GI Jobs five years in
a row and recognized as a “Best Place to Work for LGBTQ Equality” by the Human Rights Campaign Foundation for the
last eight years.
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Johnson & Johnson (USA) Announces Six Global Winners for the 2021
Women in STEM2D Scholar Awards
29
Johnson & Johnson announced its prestigious Women in STEM2D Scholar Award recipients, marking the fifth year since
the Awards’ inception. The program recognizes one scholar in each STEM2D discipline: Science, Technology,
Engineering, Math, Manufacturing and Design, and provides each recipient with $150,000 in research funding and three
years of mentorship from Johnson & Johnson. Six diverse, international female recipients were selected out of a
competitive global applicant pool that garnered more than 650 applications from 40 countries. Launched in 2017, the
Johnson & Johnson WiSTEM2D Scholar Awards aims to fuel the development of female STEM2D leaders and feed the
STEM2D talent pipeline by sponsoring women at critical points in their careers. This year is especially noteworthy given
the continued impact of the COVID-19 pandemic.
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Quest Diagnostics (USA) Named a "Best Place to Work for Disability
Inclusion" for Fourth Consecutive Year
30
Quest Diagnostics the world's leading provider of diagnostic information services, announced it has been named to the 2021 Disability Equality Index®
(DEI) Best Places to Work for Disability Inclusion by Disability: IN and the American Association of People with Disabilities (AAPD). As part of its
commitment to empowering people with disabilities, Quest launched the DiverseAbilities Employee Business Network in 2016, an open-door network
of 300 members. The vision of the group is to create and foster an inclusive culture of knowledge and dynamic acceptance of the disability community,
and support the company's goal of becoming an Employer of Choice for the disability community. The DiverseAbilities EBN is one of nine EBNs
throughout Quest which are actively engaged in driving advocacy and influencing a culture of belonging. This is the fourth consecutive year Quest has
been recognized by the DEI, which is acknowledged as the most comprehensive benchmarking tool to measure disability workplace inclusion. The
2021 DEI measured: Culture & Leadership; Enterprise-Wide Access Employment Practices (Benefits, Recruitment, Employment, Education, Retention
& Advancement, Accommodations); Community Engagement; Supplier Diversity; Non-U.S. Operations. The Disability Equality Index® (DEI) is a
comprehensive benchmarking tool helping companies build a roadmap of measurable, tangible actions towards disability inclusion and equality. It was
developed by two national leaders, American Association of People with Disabilities (AAPD) and Disability: IN, in consultation with the appointed DEI
Advisory Committee, a diverse group of experts in business, policy, and disability advocacy.
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UnitedHealth Group (USA): Optum Awards $1.4 Million in Maternal
Health Grants to Five Community Organizations
31
Optum, a leading health services company and part of UnitedHealth Group has awarded $1.4 million in maternal health grants and will provide pro bono services to five community
organizations aimed at improving maternal health outcomes and increasing health care access for underserved populations. The five community organizations awarded grants include:
• Community of Hope – based in Washington, D.C.; $500,000 to serve more pregnant women – primarily persons of color and low-income – in their comprehensive,
community-centered maternal and infant health program.
• Wake Forest Baptist Health – based in Winston Salem, North Carolina; $200,000 to create a program that will identify, in clinics and upon hospital admission, pregnant women
suffering from intimate partner violence, to provide support and resources.
• Cradle Cincinnati – based in Cincinnati, Ohio; $400,000 to reduce preterm births among Black women by expanding Cradle Cincinnati’s infant mortality reduction strategy to other
cities in the United States.
• Ladies of Hope Ministries (LOHM) – based in New York City; $200,000 to provide doula training, certification and birth support for current and formerly incarcerated pregnant
women.
These grants are part of several initiatives by Optum and its parent company, UnitedHealth Group, to address maternal health outcomes and disparities across the United States,
including a $3 million contribution to help improve access to prenatal care in underserved communities in New York and a $2.6 million grant in Nevada to reduce maternal health
disparities and help grow the state’s OB-GYN and family medicine physician workforce. To date, UnitedHealth Group has provided more than $11 million in philanthropic grants to
support maternal health. Optum’s goal is to build a fully connected health system that works for everyone, creating a world where every person has the opportunity to reach their full
health potential.
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AstraZeneca (UK) Lynparza approved in China for the treatment of
BRCA-mutated metastatic castration-resistant prostate cancer
32
AstraZeneca and MSD's Lynparza has been granted conditional approval in China to treat adult patients with germline or somatic BRCA-mutated metastatic
castration-resistant prostate cancer (mCRPC) who have progressed following treatment that included a new hormonal agent (abiraterone, enzalutamide). In
China, prostate cancer is the sixth most prevalent cancer in men, with approximately 115,000 new patients diagnosed each year and about 7% have germline
BRCA mutations.1, 2 Prostate cancer patients with these mutations are more likely to have poorer outcomes than those without the mutations.3 Around 70%
of prostate cancer patients in China have advanced disease at the time of diagnosis, and for those with mCRPC, the median survival is less than two years.
The approval by China's National Medical Products Administration was based on a subgroup analysis of the PROfound Phase III trial, which showed that
Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone or
enzalutamide in men with BRCA1/2 mutations. Continued approval is contingent upon verification and description of clinical benefit in a planned bridging
trial with Chinese patients. The subgroup analysis from the PROfound Phase III trial showed Lynparza reduced the risk of disease progression or death by
78% (based on a hazard ratio [HR] of 0.22, 95% confidence interval [CI] 0.15-0.32; nominal p<0.0001) and improved rPFS to a median of 9.8 months versus
3.0 with abiraterone or enzalutamide in men with mCRPC with BRCA1/2 mutations. In addition, Lynparza reduced the risk of death by 37% (HR of 0.63,
95% CI 0.42-0.95) with median OS of 20.1 months versus 14.4 with abiraterone or enzalutamide.
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Bristol Myers Squibb (USA) Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment
of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy
33
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of
adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior
fluoropyrimidine-based combination chemotherapy. The EC’s decision is based on results from the Phase 2 CheckMate -142 trial in which Opdivo plus
Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior
treatment with fluoropyridine, oxaliplatin and irinotecan. The safety profile for Opdivo plus Yervoy was consistent with previous studies of the
combination in other tumor types. The combination of Opdivo plus Yervoy is the first approved dual immunotherapy treatment option for any GI tumor
in the European Union (EU). This combination is also approved in the EU for non-small cell lung cancer and renal cell carcinoma. The Marketing
Authorization approves use of Opdivo plus Yervoy in all EU member states, as well as Norway, Iceland and Liechtenstein. Opdivo plus Yervoy received
approval from the U.S. Food and Drug Administration (FDA) in July 2018 for the treatment of adult and pediatric patients 12 years and older with
MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. Opdivo plus Yervoy was also
approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in September 2020 for the treatment of MSI-H unresectable advanced or
recurrent colorectal cancer progressing after cancer chemotherapy.
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Kangmei (China) Kaiyuan Central Hospital was selected as the first batch
of designated hospitals for stroke emergency map in Tieling City
34
Tieling City Stroke First Aid Map Release Conference and Tieling Stroke Center Construction Training Conference were held on June 22. The
conference released Tieling City Stroke First Aid Map, and 5 hospitals including Kangmei Kaiyuan Central Hospital were selected as the first batch of
Tieling City Stroke First Aid Maps. Hospital Kangmei Kaiyuan Central Hospital is also the only "pictured" hospital in Kaiyuan City. It is reported that
stroke, also known as "stroke" and "cerebrovascular accident", is an acute cerebrovascular disease with four major characteristics: high morbidity, high
recurrence, high disability, and high mortality. The current incidence of stroke is increasing at an annual rate of 8.7%, and 3 to 4.5 hours is the prime
time for stroke treatment. Each minute of delay in treatment will cause 1.9 million brain cell deaths. Therefore, the earlier the stroke is treated, the better
the effect. The stroke emergency map of Tieling City closely and effectively connects the common people, the "120" emergency system and medical
institutions with stroke treatment capabilities, with the central hospital as the core, and the second and third-level hospitals such as the Kangmei
Kaiyuan Central Hospital with stroke treatment capabilities. As the backbone, build an acute stroke rescue circle covering an hour’s drive, so that all
acute stroke patients in the area can reach at least one map hospital within one hour, and create a city-wide acute ischemic cerebrovascular disease
“intravenous thrombolysis” 4.5 hours, 6 hours for arterial thrombus removal, the combined treatment network within the golden time window, to
maximize the golden rescue time for stroke patients.
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Pfizer (USA): U.S. Fda Approves Prevnar 20™, Pfizer’s Pneumococcal
20-Valent Conjugate Vaccine for Adults Ages 18 Years or Older
35
Pfizer Inc. announced that the U.S. Food and Drug Administration has approved PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) for the
prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18
years and older. Following FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization
Practices (ACIP) is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in
adults. In the United States, more than half of all cases of invasive pneumococcal disease (IPD) – which include bacteremia and meningitis – in adults
ages 65 or older are due to the 20 serotypes in PREVNAR 20.21 In the United States, these 20 serotypes are estimated to cause up to 250,000 cases of
IPD (including bacteremia and meningitis) and community-acquired pneumonia and more than 10,000 deaths in adults ages 18 or older.22 Overall, the
seven additional serotypes in PREVNAR 20 account for approximately 40 percent of all pneumococcal disease cases and deaths in the U.S.23 The
FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146,
NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years
and older participated in the three Phase 3 trials, including adults 65 years of age and older, vaccine-naïve adults, and adults with prior pneumococcal
vaccination.
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Regeneron Pharmaceuticals (USA) Libtayo® (Cemiplimab) Approved by the European Commission for First-Line
Treatment of Patients with Advanced Non-Small Cell Lung Cancer With ≥50% Pd-L1 Expression
36
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo® for the first-line treatment of
adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Patients must have
metastatic NSCLC or locally advanced NSCLC and not be a candidate for definitive chemoradiation. Libtayo is now approved for three advanced cancers in the
European Union. The EC also approved Libtayo in advanced basal cell carcinoma (BCC), the first treatment to be indicated for those patients who have progressed on
or are intolerant to a hedgehog pathway inhibitor (HHI). In 2019, Libtayo was approved by the EC as the first treatment for adults with metastatic or locally advanced
cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Across all of its approved indications, Libtayo had a
generally consistent safety profile. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment
with Libtayo. The EC approval in advanced NSCLC is based on data from a global Phase 3 trial that enrolled 710 patients from 24 countries. The trial, which was one
of the largest for a PD-1 inhibitor in advanced NSCLC, was designed to be more reflective of clinical practice by including challenging-to-treat and often
underrepresented disease characteristics. Among those enrolled, 12% had pre-treated and clinically stable brain metastases, 44% had squamous cell histology and 16%
had locally advanced NSCLC that was not a candidate for definitive chemoradiation. Furthermore, patients whose disease progressed in the trial were able to change
their therapy: those assigned to chemotherapy could crossover to Libtayo treatment, while those assigned to Libtayo monotherapy could continue Libtayo treatment and
add four cycles of chemotherapy.
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Regeneron Pharmaceuticals (USA) Libtayo® (Cemiplimab) Approved By The European Commission
As The First Immunotherapy Indicated For Patients With Advanced Basal Cell Carcinoma
37
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo®
(cemiplimab) to treat adults with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on or are intolerant to a
hedgehog pathway inhibitor (HHI). BCC is the most common type of skin cancer worldwide, representing up to 80% of non-melanoma skin
cancers, and incidence is increasing across many European countries. While the large majority of BCCs are caught early and easily cured with
surgery and/or radiation, a small proportion of cases can develop into advanced BCC and penetrate deeper into surrounding tissues (locally
advanced) or spread to other parts of the body (metastatic), becoming more difficult to treat. Libtayo is now approved for three advanced cancers
in the European Union, following the EC's concurrent approval of Libtayo for the first-line treatment of adult patients with advanced non-small
cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. In 2019, Libtayo was
approved by the EC as the first treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not
candidates for curative surgery or curative radiation. Across all of its approved indications, Libtayo had a generally consistent safety profile.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.
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Roche’s (Switzerland) ENSPRYNG approved by European Commission as first and only
at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)
38
Roche announced that the European Commission (EC) has approved ENSPRYNG® (satralizumab) for the treatment of adults and adolescents
from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a
monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMOSD treatment that is administered
subcutaneously every four weeks, allowing home-dosing after appropriate training. The EC approval is supported by results from two Phase III
studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG seropositive
NMOSD. AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course compared to
those not expressing AQP4-IgG antibodies. ENSPRYNG is the first and only approved medicine for NMOSD in the EU designed to bind to and
block the interleukin-6 (IL-6) receptor, a central driver of the inflammation associated with NMOSD. The treatment was designed by Chugai, a
member of the Roche Group, using novel recycling antibody technology. When compared to conventional antibodies, ENSPRYNG’s recycling
antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6
receptor) – maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.
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Shanghai Pharmaceutical (China) Dongying Parecoxib Sodium for
Injection was approved for production
39
Shanghai Pharmaceuticals Dongying Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Shanghai Pharmaceuticals Group Co., Ltd., received the "Drug
Registration Certificate" issued by the National Medical Products Administration of Shanghai harmaceutical Dongying (Jiangsu) Pharmaceutical Co., Ltd.
Approve production. Parecoxib sodium for injection is mainly used for short-term treatment of postoperative pain and is one of the basic drugs for clinical
multimodal analgesia. Since its launch, it has been recommended by authoritative guidelines at home and abroad to be widely used in the treatment of
postoperative pain in many departments such as general surgery, gynecology, orthopedics, and stomatology. It was first developed by Pfizer and launched in
Europe in 2002. The IQVIA database shows that the hospital purchase amount of parecoxib sodium for injection in 2020 is RMB 2,189.51 million. According
to relevant national policies, the types of generic drugs approved under the new registration classification will receive greater support in areas such as medical
insurance payment and procurement by medical institutions. The approval of the production of parecoxib sodium for injection by Shanghai Pharmaceuticals
Dongying is a gratifying first step for the company's new product launch, which has enhanced the company's market competitiveness. In the future, Shanghai
Pharmaceutical Dongying will accelerate product layout and development, vigorously develop new products and new dosage forms in a variety of ways, and
work with Shanghai Pharmaceutical Kangli to realize the joint development of raw material preparations, explore advantageous varieties, deepen
advantageous areas, and jointly create raw material preparation integration Platform to enhance the core competitiveness of enterprises.
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Partner Ecosystem Updates
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Caelum and Alexion (USA) Present Additional Phase 2 Data Reinforcing Safety and Tolerability
of CAEL-101 in ALAmyloidosis at the European Hematology Association Congress 2021
40
Caelum Biosciences and Alexion Pharmaceuticals, Inc. announced new Phase 2 safety and tolerability data for CAEL-101, a
potentially first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in patients with
AL amyloidosis. The data, presented in two e-posters at the European Hematology Association (EHA) Congress 2021,
strengthen the safety and tolerability profile of CAEL-101, further support the dose selection for the ongoing Phase 3 study,
and suggest possible cardiac and renal response. An e-poster featuring the first data from a new arm of the study demonstrated
that CAEL-101 administered in combination with cyclophosphamide-bortezomib-dexamethasone (CyBorD) plus
daratumumab was generally safe and well-tolerated in the first four weeks of treatment. Data presented in a second e-poster
showed longer-term evidence that CAEL-101 in combination with CyBorD was generally well-tolerated for a median
treatment duration of 49 weeks, and exploratory clinical biomarker data suggesting possible cardiac disease improvements
and renal response among patients with cardiac or renal impairment at baseline, respectively.
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Align Technology (USA) Introduces the Limited-Edition Charli D’amelio X
Invisalign® Aligner Case
41
Align Technology, Inc. a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear
aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative, announced its first
limited-edition product, the Charli D’Amelio x Invisalign® Aligner Case, created exclusively for the Invisalign brand by social media
star Charli D’Amelio (@charlidamelio). Over the past year, Charli has been documenting her Invisalign treatment journey, and as an
expression of that experience, has designed a special, limited-edition case for Invisalign aligners. The Charli D’Amelio x Invisalign®
Aligner Case features a pink exterior, lavender interior, and printed text with Charli’s signature mantra, “All Smiles Here.” A magnetic
closure ensures the case stays securely fastened and a textured liner minimizes movement while in transit. Cases will be available for
$24.99 each and can be purchased from the official Invisalign store: https://www.invisalignaccessories.com. The official Invisalign store
features the most extensive Invisalign product catalogue, including products and accessories not available elsewhere. The teen icon has
been working with the Invisalign brand for the last year. The relationship started as a way to provide Charli with cutting-edge orthodontic
treatment to give her a superior smile, while fitting into her active lifestyle.
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Amgen (USA) and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a
Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis
42
Amgen Sand Kyowa Kirin Co., Ltd. announced an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin's potential
first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in
other autoimmune diseases. In February, Kyowa Kirin announced positive results from a Phase 2 study of KHK4083 in patients with
moderate-to-severe atopic dermatitis, which affects nearly 30 million people in major global markets1. Under terms of the agreement, Amgen will
lead the development, manufacturing, and commercialization for KHK4083 for all markets globally, except Japan, where Kyowa Kirin will retain
all rights. Additionally, Kyowa Kirin will co-promote KHK4083 with Amgen in the U.S. and have opt-in rights to co-promote KHK4083 in certain
other markets outside the U.S., including in Europe and Asia. Amgen will make a $400 million up-front payment to Kyowa Kirin and future
contingent milestone payments potentially worth up to an additional $850 million, as well as significant royalty payments on future global sales.
Kyowa Kirin and Amgen will share global development costs, except in Japan, and U.S. commercialization costs. Amgen will consolidate sales
for KHK4083 in all markets globally, except for Japan. Amgen also will leverage unique data from its deCODE Genetics subsidiary to inform the
potential use of KHK4083 in indications beyond atopic dermatitis. The closing of the transaction is conditioned on obtaining any necessary
consents and approvals.
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Affinivax and Astellas (Japan) Present Safety and Immunogenicity Data from Phase 2
Study of ASP3772, a Novel 24 valent MAPS™ Vaccine for Streptococcus pneumonia
43
Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting
Streptococcus pneumoniae. Developed using Affinivax’s proprietary MAPS™ platform technology, ASP3772 is designed to offer both B-cell
(antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides, as well as two
conserved pneumococcal proteins. The results from the Phase 2 clinical trial demonstrated that ASP3772 was well tolerated. ASP3772 also
exhibited an antibody response to each of the 24 polysaccharides, as well as an additional antibody response to the conserved pneumococcal
proteins. The Phase 2 data for ASP3772 were delivered in an oral presentation at the 31st European Congress of Clinical Microbiology &
Infectious Diseases (ECCMID), taking place online from 9 – 12 July 2021. The U.S. Food and Drug Administration (FDA) has also granted
Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae
serotypes included in ASP3772 in adults aged 50 years and older. The FDA decision is informed by the results of the Phase 2 data. The FDA’s
Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening
condition. Designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over
available therapies on one or more clinically significant endpoints.
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Bio-Rad (USA) Announces Partnership with Seegene for Molecular Diagnostic Testing
Products
44
Bio-Rad Laboratories, Inc. a global leader of life science research and clinical diagnostic products announced a
partnership with Seegene, Inc., a global leader in multiplex molecular diagnostics, for the clinical development and
commercialization of infectious disease molecular diagnostic products. Under the terms of the agreement, Seegene, based
in Seoul, Korea, will provide diagnostic tests for use on Bio-Rad's CFX96™ Dx Real-Time PCR System for U.S. markets
pending clinical development and clearance from The U.S. Food & Drug Administration (FDA). Seegene assays offer
multiplex real-time PCR detection and differentiation, with high sensitivity and specificity of up to seven targets in a
single reaction. The assays deliver results in approximately four hours.
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Eisai (Japan) and Bristol Myers Squibb (USA) Enter into Global Strategic
Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate
45
Eisai Co., Ltd. and Bristol-Myers Squibb Company announced that the companies have entered into an exclusive global strategic collaboration agreement for the
co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC). MORAb-202 is Eisai’s first ADC and combines Eisai’s in house developed
anti-folate receptor alpha (FRα) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FRα ADC with a favorable
pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors. Eisai is currently investigating MORAb-202 in FRα-positive solid tumors
(inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States. The companies
are planning to move into the registrational stage of development for this asset as early as next year. Under the agreement, Eisai and Bristol Myers Squibb will jointly develop
and commercialize MORAb-202 in the following collaboration territories: Japan; China; countries in the Asia-Pacific region*; the United States; Canada; Europe, including the
European Union and the United Kingdom; and Russia. Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the
collaboration territories. Eisai will remain responsible for the manufacturing and supply of MORAb-202 globally. Under the financial terms of the agreement, Bristol Myers
Squibb will pay $650 million U.S. dollars to Eisai including $200 million U.S. dollars as payment toward Eisai research and development expenses. Eisai is also entitled to
receive up to $2.45 billion U.S. dollars in potential future development, regulatory, and commercial milestones. The parties will share profits, research and development and
commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories. Eisai is expected to
book sales of MORAb-202 in Japan, China, countries in the Asia-Pacific region, Europe and Russia. Bristol Myers Squibb is expected to book sales of MORAb-202 in the
United States and Canada.
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Cardinal Health (USA): Outcomes™ partners with Medicaid plans to help
Ohio Medicaid members get vaccinated
46
Ohio Governor Mike DeWine's request that business leaders help increase vaccination rates, four Ohio Managed Care Organizations (MCOs) are
partnering with Outcomes™ to leverage the expertise and trusted status of local pharmacists for vaccine consultation and administration,
particularly in underserved communities. On behalf of Buckeye Health Plan, Molina, Paramount and UnitedHealth care, Outcomes, recently
launched by Cardinal Health (NYSE: CAH), created a Needs Immunization service on the Connect™ platform to engage local pharmacists in
personal outreach to Ohio Medicaid members who have not yet received a COVID-19 vaccination. The Centers for Disease Control (CDC) have
stated that COVID-19 vaccines have been rigorously evaluated for safety and effectiveness and recommends that all people 12 years and older be
vaccinated for prevention of COVID-19 as soon as possible. In this proactive consultation, the pharmacist connects with a Medicaid member to
address any specific concerns or questions the patient may have about the vaccine, explain how to receive the vaccine and if possible, administer
the vaccine on the spot. The Needs Immunization service also provides pharmacists access to best practices for addressing vaccine hesitancy.
Participating pharmacies earn a medication therapy management (MTM) service fee for completing the intervention and documenting the
consultation in the Outcomes platform, including vaccine administration date. If the vaccine is not administered at their pharmacy, the pharmacist
follows up with the patient after their consultation to confirm they received the vaccine elsewhere.
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Centene (USA) Reaches No-Fault Agreements with Ohio and Mississippi to
Resolve Pharmacy Subsidiary Claims
47
Centene Corporation announced that it has reached no-fault agreements with the Attorneys General of Ohio and Mississippi to resolve claims made by the states
related to services provided by Envolve Pharmacy Solutions, Inc. (Envolve), its pharmacy benefits manager subsidiary. Under the terms of these agreements,
Centene will pay $88 million to Ohio and $55 million to Mississippi. The practices described in the settlement focus on the structure and processes of Envolve,
primarily during 2017 and 2018. In the settlements, the Company denies any liability for these practices. As a result of the settlement, the Ohio Attorney General's
litigation against the Company will be dismissed. In early 2019, Centene proactively restructured its pharmacy benefits operations to create a more transparent
relationship between its health plans and its pharmacy benefits manager. Since that time, Centene has also aligned all Medicaid, Medicare and health insurance
marketplace products on transparent pharmacy networks to eliminate spread pricing. Going forward, Envolve will operate as an administrative service provider,
not a PBM, on behalf of Centene's local health plans to further simplify our pharmacy operations. Additionally, the Company is in discussions with a plaintiff's
group led by the law firms of Liston & Deas and Cohen & Milstein in an effort to bring final resolution to these concerns in other affected states. Consistent with
those discussions, Centene has recorded a reserve estimate of $1.1 billion related to this issue, exclusive of the above settlements. Centene Corporation is a leading
multi-national healthcare enterprise that is committed to helping people live healthier lives. The Company takes a local approach – with local brands and local
teams - to provide fully integrated, high-quality, and cost-effective services to government-sponsored and commercial healthcare programs, focusing on
under-insured and uninsured individuals.
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DaVita (USA) and the NKF Join Forces to Improve Health Equity in Kidney
Transplantation
48
DaVita Kidney Care and the National Kidney Foundation announced their collaboration in launching an innovative, yearlong pilot aimed at improving health
equity in kidney transplantation with a newly-developed program within NKF’s THE BIG ASK: THE BIG GIVE platform. The pilot will take place in Colorado,
New York, Minnesota and New Mexico. DaVita and NKF carefully selected these states because each has a unique opportunity to improve health equity in kidney
transplantation. In addition, both organizations have a strong, on-the-ground presence in these states, with operational teams that are well connected to the
transplant and health care ecosystem. NKF’s THE BIG ASK: THE BIG GIVE platform empowers kidney patients and families to share the need for a kidney with
their community and find a living donor. Through this new pilot program, which offers extensive support and tools in a virtual format, NKF will provide
high-touch, in-depth education and support to patients and families seeking a kidney transplant from a living donor. The program includes one-on-one guidance
from a trained Patient Navigator, interactive tools on a new web platform, a private online community for program participants, and support from healthcare
professionals. More than 500,000 people in the United States are currently living with kidney failure. The only treatment option that allows them to live without
dialysis is to receive a transplant. However, there are nearly 100,000 individuals waiting to receive a kidney, with an average wait time of three to seven years for
a deceased donor depending on where a person lives. For this reason, many patients with kidney failure can benefit from living organ donation, which typically
can take place much sooner. While a kidney from a deceased donor may only remain viable for 8-12 years, a transplanted kidney from a living donor can continue
functioning properly for 12-20 years – limiting the potential need for dialysis later in life.
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Grifols (Spain) signs Power Purchase Agreement with RWE to meet 28% of
its national electricity needs using solar energy
49
Grifols a leading global producer of plasma-derived medicines with a history of more than 110 years contributing to improve the
health and well-being of people, and RWE Renewables, one of the world’s leading renewable energy companies, announced they
have signed a 10-year Power Purchase Agreement (PPA) through which Grifols will buy enough clean electricity to meet 28% of its
total yearly electricity needs in Spain. Under the agreement, Grifols will purchase the entire output of a 21-hectare solar farm that
RWE is developing in Las Vaguadas, Badajoz, as much as 25 GWh yearly (power capacity of 10MWac), or sufficient green electricity
to supply a town of about 21,000 people annually. More than 7,600 tons of CO2 will be saved each year. The solar farm is expected
to be operational in the first half of 2022 and will add to Spain’s existing clean-energy infrastructure. Until then, Grifols is meeting
its green-electricity target through the purchase of Renewable Energy Certificates (RECs) from RWE. Grifols anticipates future PPAs
in Spain and other markets where it operates, including the United States, as the company steadily shifts its energy-use profile to
achieve its sustainability commitments for 2030: use renewable energies for at least 70% of electricity consumption, reduce
greenhouse gas emissions per unit of production by 40% and increase energy efficiency per unit of production by 15%.
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Grifols (Spain) becomes official partner of UEFA Women’s Football
50
Grifols a leading global producer of plasma-derived medicines with a history of more than 110 years contributing to improve the
health and well-being of people announced it has become an official partner of the Union of European Football Associations’(UEFA)
Women’s Football beginning with the 2021/22 season and until the end of the 2025 competitions. Under the four-season partnership,
Grifols becomes the exclusive healthcare company partner of women’s football at all tournament levels, including the UEFA
Women’s Champions League, the UEFA Women’s Euro, the UEFA Women’s Under-19 and Under-17 Championships, and the UEFA
Women’s Futsal EURO, as well as UEFA’s Together #WePlayStrong initiative, which aims to encourage more girls and women to
play football. Women account for 60% of the workforce at Grifols, which in early 2021 was included in the Bloomberg
Gender-Equality Index for its commitment to the advancement of women in the workplace. As part of its agreement, Grifols will be
able to undertake multiple branding and promotional activities across its own internal and external channels as well as UEFA
properties. Activations could include in-stadium fixed and rotating LED boards, matchday and on-site promotions, premium
giveaways, hospitality and digital actions on social media platforms.
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GSK and iTeos Therapeutics announce development and commercialisation collaboration for EOS-448,
an anti-TIGIT monoclonal antibody, enabling novel next-generation immuno-oncology combinations
51
GlaxoSmithKline plc and iTeos Therapeutics announced an agreement to co-develop and co-commercialise EOS-448, an anti-TIGIT monoclonal antibody
currently in phase I development as a potential treatment for patients with cancer. TIGIT, part of the CD226 checkpoint axis, has demonstrated potential as
a promising target for the next generation of immuno-oncology therapies based on compelling preclinical data and a phase II randomised clinical trial. With
this collaboration GSK is uniquely positioned with access to antibodies that synergistically target all three known CD226 checkpoints - TIGIT, CD96 and
PVRIG. Since GSK validated the role of CD226 axis targets as important in oncology, it has been strategically building a carefully constructed set of assets
to target this network of checkpoint inhibitors. The addition of EOS-448 results in GSK being the only company with antibodies targeting all three known
checkpoints – TIGIT (via EOS-448), CD96 (via GSK’608), and PVRIG (via GSK’562). Together with GSK’s recently approved anti-PD-1, Jemperli
(dostarlimab), this comprehensive portfolio of potential next generation immuno-oncology agents will be explored through various novel combinations,
including doublets and triplets, to evaluate their potential to transform treatment options for patients with multiple different cancers. EOS-448 is currently in
an open-label phase I study in patients with advanced solid tumours. GSK and iTeos plan to start combination studies of EOS-448 with dostarlimab in 2022.
GSK’608 (anti-CD96 being developed in collaboration with 23andMe) is in phase I as monotherapy and in combination with dostarlimab. GSK expects to
submit an Investigational New Drug application for GSK’562 (anti-PVRIG in-licensed as SRF-813 from Surface Oncology) by mid-2022.
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Pfizer (USA): ViiV Healthcare and Halozyme enter global collaboration and license agreement for ENHANZE®
drug delivery technology to enable development of “ultra long-acting” medicines for HIV
52
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc. and Shionogi Limited as
shareholders, and Halozyme Therapeutics, Inc. announced a global collaboration and license agreement that gives exclusive access to Halozyme’s
ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment
and prevention of HIV. Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the
exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in
development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain
specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the
technology. The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body’s subcutaneous space (under the skin)
that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts
of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous
injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored
under the skin via normal processes within 24-48 hours.
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