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Today's Rundown

Featured Story

Merck, via its Themis buy, to move first COVID-19 vaccine into clinical development in Q3

Merck was purposely cautious during the start of the pandemic when it came to vaccine development but is now slowly but surely ramping up its efforts into the clinic.

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Top Stories

J&J COVID-19 vaccine candidate protects monkeys after single dose

Scientists led by Beth Israel Deaconess Medical Center in Boston tested seven different COVID-19 vaccine candidates from J&J in nonhuman primates, landing on one that prevented the virus from infecting the animals' lungs with a single dose. The company plans to test both a one- and two-dose regimen in clinical trials.

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Cerevel to raise $445M, hit Wall Street via blank check company

Unlike a traditional biotech built around a lab discovery, Cerevel Therapeutics got a “unique” start: with $350 million from Bain Capital and a clutch of central nervous system programs from Pfizer. Now, it’s continuing its unorthodox streak as it taps the public markets.

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Sponsored: FROM CHOLERA TO COVID-19: How integrated data visualizations inform decisions and impact actions

How integrated data visualizations inform decisions and impact actions. Data visualization was first used to recognize disease patterns in the 1854 London cholera outbreak. It is even more essential today.

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BioNTech, Regeneron join forces in I-O battle against melanoma

Checkpoint inhibitors can be lifesaving for some cancer patients, but in melanoma, at least half of patients don’t respond to drugs like Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. And those who do often develop resistance to the drug. BioNTech and Regeneron are teaming up to help those patients.

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AlloVir raises $276M IPO to run broad cell therapy program

AlloVir has raised $276 million in an upsized IPO to fund development of allogeneic T-cell treatments for viral diseases. The money will equip AlloVir to embark on a broad clinical development program for a phase 3-ready cell therapy that targets five viruses.

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Bristol Myers, bluebird refile for CAR-T approval after FDA rejection

Bristol Myers Squibb and bluebird bio have refiled for approval of anti-BCMA CAR-T therapy ide-cel. The action, which comes two months after the FDA hit the partners with a refuse to file letter, keeps Bristol Myers in with a shot of winning approval before a deadline set in its takeover of Celgene.

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U.K. antibody test approved to support government's free coronavirus screening efforts

A coalition of U.K. research institutions and diagnostic developers backed by the British government has secured regulatory clearance to move ahead with their hand-held antibody blood test for COVID-19.

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Top vaccine players Sanofi, GSK win $2.1B Warp Speed funding for COVID-19 shot

Sanofi, already working with BARDA on a GlaxoSmithKline-partnered COVID-19 vaccine, has won further support from the U.S. government—this time, to the tune of $2.1 billion for clinical development and delivery of 100 million doses. It's a hefty bet, but on a proven vaccine technology from two of the biggest vaccine makers in the business.

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FiercePharmaAsia—Daiichi's win-lose week; Astra's China business; Novavax-Fujifilm COVID-19 vax deal

Daiichi Sankyo won a $1 billion upfront deal with AstraZeneca on an anti-TROP antibody-drug conjugate but lost a pediatric pentavalent vaccine collab with Sanofi. AstraZeneca's China business was hurt by a huge Pulmicort decline. Fujifilm will make Novavax's experimental COVID-19 vaccine. And more.

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Chutes & Ladders—Nura Bio uncloaks with Seth at the helm

Nura Bio has uncloaked with a $73 million financing round and Alpna Seth as CEO; Parexel taps Sanofi vet Joe as CMO; Parexel hires trio of regulatory vets.

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Resources

Whitepaper: High-Loaded Dosage Forms: Novel Platform Expands Spray-Dried Dispersion Utility

A novel spray-dried dispersion platform has been developed to faciliate high drug load applications

Whitepaper: Learn How to Navigate Pediatric Clinical Trials Under the New RACE Act

Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need.

eBook: Cambrex eBook - Small molecules: 2020 vision

The industry trend of outsourcing to CDMOs continues. With more services, capabilities, facilities, and employees than ever before, our experts have contributed more articles to our biggest eBook yet.

White Paper: Patient Switching Behaviors Impact on Adherence and Engagement: A Predictive Analytics and Machine Learning Approach to Improving Hub Performance and Patient Outcomes

How predictive analytics and machine learning have the potential to transform healthcare by predicting “Patient Switching Behaviors.”

Whitepaper: You've Decided on a Multiparticulate Dosage Form. Now What?

Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project.

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.

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.

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