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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Good things come in threes. J&J’s single-shot vaccine finally got its green light from the FDA, but now it has to overcome public hesitancy, and comparisons with its (good-natured) rivals—namely, its 66% overall effectiveness rate. CEO Alex Gorsky took to the talk show circuit this week, pointing to its 85% rate against serious cases and 100% stat in preventing deaths, while facing down COVID’s emerging variants. Meanwhile, J&J struck a “wartime” pact with its competitor Merck to help produce, package and ship the shot. Those stories, plus our top reads of the week, follow below.

Featured Story

Merck, Johnson & Johnson to strike 'wartime' COVID-19 vaccine manufacturing deal: WaPo

Merck & Co., a leading vaccine player worldwide, has been largely absent during the COVID-19 vaccine race. Not anymore: The drugmaker is set to partner with Johnson & Johnson to boost production of its newly authorized shot, The Washington Post reports.

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Top Stories Of The Week

GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3

GlaxoSmithKline and partner Vir have seen a key, late-stage test of their experimental COVID drug stopped for new patients amid concerns it may not be working well enough.

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New approaches to treating cancer with off-the-shelf immune-stimulating bispecific antibodies

Three Johns Hopkins research groups designed bispecific antibodies so they simultaneously bind to tumor antigens and T cells, resulting in drugs that could offer off-the-shelf immuno-oncology to a wide variety of cancer patients, they argued. The drugs showed promising efficacy in preclinical models.

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J&J's next COVID-19 vaccine challenge? Hurdling the '66%' perception to win over a vaccine-hesitant public

As Johnson & Johnson rolls out its COVID-19 vaccine under a new FDA emergency authorization, the pharma faces a communications hurdle. How will it counter the wide and spreading discussions about the shot's overall effectiveness of 66% when compared to Pfizer and Moderna's 90%-plus effectiveness rates?

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What does it take to supply COVID-19 vaccines across the globe? Here's how the leading players are working it

As COVID-19 gained steam worldwide last spring, little was known about the disease and the havoc it would wreak on the world. A year later, vaccines offer hope in the global effort to end the pandemic, but it will be a monumental task to produce them and deliver them around the world.

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Merck must do a new trial for faltering $425M COVID-19 drug the U.S. government asked it to buy

It’s already had to give up on any hopes of creating a vaccine against COVID-19, and now Merck is being told that its pandemic drug hopeful will need another trial before it can be issued a green light.

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AstraZeneca cashes in on Moderna, collecting $1B-plus as COVID-19 added rocket fuel to the mRNA biotech's shares

Another investor has benefited big time—to the tune of $1 billion—from Moderna's surging stock price during its work on COVID-19. AstraZeneca cashed out its entire 7.7% stake in the mRNA specialist last year, the British pharma said in its annual report, collecting a big return on its $290 million investment.

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FDA accepts gefapixant for review in cough, positioning Merck to get head start on Bayer and Bellus

The FDA has accepted a filing for approval of Merck’s P2X3 receptor antagonist gefapixant for review. Merck is seeking approval on the basis of phase 3 trials that linked the oral drug to improvements in several measures of chronic cough symptoms but confirmed tolerability concerns.

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Novo Nordisk re-engages comedian Billy Gardell for branded Ozempic campaign

Actor and comedian Billy Gardell is definitely in the zone—the Type 2 diabetes health zone, that is. And he's taking his good health to a starring role once again for Novo Nordisk, this time in branded advertising for Ozempic.

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AbbVie sells biologics plant to Pharmaron, fueling the China company's cell and gene therapy ambitions

AbbVie is pawning off an Allergan biologics plant in the U.K. As part of an expansion in cell and gene therapy, China-based Pharmaron will shell out $119 million for the Liverpool, England facility, planning to keep its 150 workers on the job.

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Roivant Sciences to absorb Silicon Therapeutics with $450M-plus deal

Roivant Sciences has moved to take molecule designer Silicon Therapeutics underneath its corporate umbrella in a deal worth $450 million or more that will merge its computational physics work with the efforts of its VantAI drug discovery outfit.

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Resources

Guide: How to maximize your drug commercialization investments

Unlock product potential by making the most of your commercialization investments. 

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Download our whitepaper to learn how BC Platforms has leveraged our technical expertise to offer robust and comprehensive solutions to maximize RWD ROI.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

Report: New research indicates an accelerated shift to decentralized clinical trials

New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19.

Content Hub: How to improve the virtual work you do every day

We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met.

Webinar: Age-Appropriate Formulation Development for Pediatric Trials-Challenges and Considerations

Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives.

eBrief: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

Case Study: Establishing Parameters for Success

Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study.

Fact Sheet: Forecasting to Optimize Clinical Trial Supply Management

Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study.