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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

While new research says human antibodies may only protect against the novel coronavirus for two to three months, CEO Pascal Soriot said AstraZeneca’s vaccine is expected to work for a full year. The drugmaker is also moving quickly: efficacy trial results could come at the end of the summer, he said, while manufacturing grows in parallel—including a plan with Catalent to produce 2 billion doses per year. Meanwhile, China’s Sinopharm said its vaccine triggered strong immune responses, amid reports that doses are already being offered to employees of other state-run companies. Those stories, plus our top reads of the week, follow below.

Featured Story

AstraZeneca CEO Soriot says fast-tracked COVID-19 shot will protect for just one year

AstraZeneca, advancing a COVID-19 vaccine from the University of Oxford, is among global frontrunners in the worldwide hunt for a viable vaccine. But the drugmaker’s CEO now says the vaccine will only provide protection for about a year. 

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Top Stories Of The Week

CRISPR and Vertex show durability of gene-editing therapy, hoping for one and done treatment 

CRISPR Therapeutics and Vertex have presented updated data on the first patients treated with their CRISPR/Cas9 gene-editing therapy. The partners now have evidence that one-time treatment with CTX001 improves outcomes in sickle cell disease and beta thalassemia patients for up to 15 months.

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China's Sinopharm touts 100% antibody response for COVID-19 vaccine it's already giving to workers

China's state-run Sinopharm said one of its inactivated COVID-19 vaccines triggered a strong neutralizing antibody response in a phase 1/2 study. And even as the design of a phase 3 trial is still under wraps, the company is reportedly offering the experimental vaccine to employees at state-owned companies who intend to travel overseas.

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Eli Lilly's R&D revolving door spins again as Gandhi heads back to Dana-Farber

A little over two years into her stint leading immuno-oncology medical development at Eli Lilly, Leena Gandhi M.D., Ph.D., is hitting the exit.

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AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant

British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine. To reach that lofty goal, AstraZeneca has struck a deal with New Jersey-based Catalent to help with the final stages of the shot's manufacturing. 

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Vaccine heroes? COVID-19 pitfalls, pricing put pharma on the spot

Pharma is looking to reset its image with COVID-19 vaccines and treatments, but landmines loom—with pricing likely the biggest. It's true that the halo from pharma’s rapid response in R&D has propelled the industry’s reputation to an all-time high. But some tough decisions lurk just beyond the lab.

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Novavax, advancing COVID-19 shot, recruits AstraZeneca exec as its chief medical officer

On the heels of some big fundraising moves and in the hunt for a COVID-19 vaccine, Novavax is adding some heft to its executive team. Joining the vaccine specialist as chief medical officer is Filip Dubovsky, an AstraZeneca veteran.

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FDA clears its first prescription video game treatment for ADHD

The FDA has cleared its first video game for children with attention deficit hyperactivity disorder, allowing Akili Interactive’s EndeavorRx to be prescribed as a digital therapeutic.

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GlaxoSmithKline pens $120M upfront synthetic lethality cancer pact with Fierce 15 winner Ideaya

As GlaxoSmithKline looks to deepen its cancer R&D, it's penned an oncology development program with Ideaya Biosciences.

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Is dexamethasone really a COVID-19 breakthrough? Not so fast, doctors say

Top-line results from a U.K. study of a low-cost steroid were enough to persuade the National Health Service to approve it for COVID-19 patients requiring oxygen or ventilation. That OK came just hours after the data reveal—and now, some doctors warn there's not enough evidence that it's really effective in treating the coronavirus.

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Gene editing turns immune cells into more potent cancer killers

University of California, San Diego researchers edited a gene called CISH from the immune system's natural killer (NK) cells, freeing up the signaling of cytokines—molecules that direct immune cells to destroy invaders. The edited NK cells cleared leukemia in mouse models and could prove promising as an off-the-shelf cell therapy for some cancers, the researchers said.

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Resources

Case Study: Pharma Sponsor Enlists Cenduit to Rescue a Multi-Country, Multi-Site Oncology Study

Download this case study to read how Cenduit helped one client successfully navigate mid-study changes to medication management.

Whitepaper: 4 Ways to Keep Pace with Big Pharma, Even On a Start-Up Budget

Learn four ways to squeeze more value from your limited R&D resources.

eBook: Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies

Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies

Whitepaper: Brand Revitalization with RP Scherer Softgel Solutions for Analgesics

In a series of innovation sessions, Catalent RP Scherer softgel capsules were quickly identified as the ideal solution to drive incremental growth. Learn more.

Whitepaper: 7 Keys to Success in Europe

White paper describing 7 keys to success for any biopharma company that is entering (or thinking about entering) Europe.

Whitepaper: The Evolution and Importance of Biomedical Ontologies for Scientific Literature

Dive into the history of biomedical classification and how these systems have evolved to address new technology and use cases.

Whitepaper: Pandemic respiratory vaccine clinical trials: a departure from business as usual

Download this whitepaper to learn more about the success factors that are required to keep a pandemic respiratory vaccine trial running at optimal speed and efficiency.

Whitepaper: Rapid BYOD Build Timelines

This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations.

Whitepaper: Keep Your GI Trials Moving During COVID-19

Learn how GI specific data capture solutions can support virtual and hybrid trials during COVID-19.

Executive Summary: Overcoming Manufacturing Challenges for Accelerated Drug Development

Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project.

Presentation: Flexible Manufacturing Strategies

Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible.

Executive Summary: Strategies for Flexible Manufacturing

This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market.

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.

Case Study: Precision Analytics for Product Launch and Growth

Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. 

eBook: Expecting the Unexpected: Strategies for Efficient Clinical Supply Management and Forecasting

Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study.