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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

After an ingredient mix-up trashed up to 15 million J&J doses last month, Emergent’s Baltimore plant has paused production following an FDA inspection. It’s another blow to the vaccine, with broader distribution on hold pending reviews of rare blood clots. Meanwhile, Moderna delayed deliveries to Canada and the U.K., thanks to hiccups in its European supply chain, and Roche has cut two midstage COVID-19 assets from its pipeline. But companies still aim to capitalize on a year of science in the international spotlight, and the biggest ad spenders in biopharma hope to reach people at home as the world realigns to the pandemic.

Featured Story

FDA orders shutdown at Emergent's troubled plant 2 weeks after handing J&J the keys

Johnson & Johnson’s takeover of COVID-19 vaccine manufacturing at an error-prone Emergent BioSolutions plant didn’t last long. At the FDA's request, Emergent stopped production just two weeks after J&J took over manufacturing its shot there.

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Top Stories Of The Week

Combining AstraZeneca's 'good' cholesterol booster with PCSK9 inhibition shows promise in heart disease

Scientists at AstraZeneca have early data showing that an experimental antibody drug increases "good" HDL cholesterol in monkeys and people. Combining the drug with a PCSK9 inhibitor appeared to have a synergistic effect.

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Special Report—The top 10 ad spenders in Big Pharma for 2020

Even as other industries slashed ad budgets, pharma advertisers continued to spend on TV and digital especially—reaching a total of $6.6 billion in 2020.

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As blood clot concerns mounted, J&J reached out to rival COVID-19 vaccine makers to form alliance: WSJ

As concerns over cases of rare but severe blood clots among vaccinated people mounted last week, Johnson & Johnson reportedly reached out to rival COVID-19 vaccine makers for help, and only one agreed, The Wall Street Journal reports.

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Moderna cuts COVID-19 vaccine deliveries to Canada, U.K. amid European supply struggles

Moderna warned that it will deliver fewer doses than previously anticipated to “a number of countries,” including the U.K. and Canada. 

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The dogtor is in: Study finds dogs can sniff out COVID-19 with 96% accuracy

A new study led by researchers from the University of Pennsylvania found that mass COVID-19 screening could be solved by a quick sniff from a dog—a dognostic test, if you will.

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Vertex takes the lead in CRISPR Therapeutics partnership with $900M upfront

Vertex has boosted an agreement with CRISPR Therapeutics to $900 million upfront as the companies race to beat bluebird bio to the market with a new gene editing therapy for sickle cell disease and beta-thalassemia called CTX001.

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Biogen’s Alzheimer’s hopeful aducanumab faces ‘less than a coin flip’s chance’ of FDA approval: analysts

As the June decision date draws near for Biogen’s controversial Alzheimer’s drug aducanumab, analysts at RBC Capital Markets are raising concerns about the drug's prospects for approval. They considered eight recent developments—some specific to the drug and others more generally related to the Alzheimer’s market environment.

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AstraZeneca cancer R&D exec Ferté hits the exit

Charles Ferté, senior director and global project leader of oncology R&D at AstraZeneca, is leaving the company.

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Roche culls 2 COVID-19 drug hopefuls amid Q1 clear-out

Roche has cut a series of experimental lung drugs from its pipeline, including two midstage COVID-19 assets.

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Genentech, Novartis get FDA nod for self-injectable Xolair

The FDA has approved a self-injectable form of Genentech and Novartis’ Xolair. Introducing the new prefilled syringe product will free patients from the need to visit healthcare providers to get treated. 

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CVS, Walgreens begin rolling out over-the-counter COVID tests from Abbott, Ellume and more

After spending months churning out tens of millions of its card-sized coronavirus antigen tests, Abbott has begun shipping the BinaxNOW tests nationwide to CVS, Walgreens and Walmart stores.

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Bluebird bio lays off staffers in Europe as Zynteglo rollout hits an early reimbursement snag

The rollout of bluebird bio’s blood disease gene therapy Zynteglo is off to a rough start—to say the least. After resolving a manufacturing-related setback and overcoming another delay caused by COVID-19, the biotech has failed to reach a reimbursement agreement in Germany, its first launch country.

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Resources

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Whitepaper: COVID-19 Survey report: The Lasting Impact on Outsourcing Decisions

How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond?

Content Hub: Emerging Biotech Resource Center

A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule

Whitepaper: Top 5 Benefits of a Cloud ELN

Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes.

Special Report: The Marketer’s Guide to Taking the Vaccine Viral

Access this guide for the latest insights into how marketers can use data, technology, and personalized messaging to build vaccine confidence and drive successful immunization efforts.

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: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

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

Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. 

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.