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Today's Rundown

Featured Story

FDA tells Merck to show more data for its OncoImmune COVID-19 drug as EUA pushed back

Merck will no longer be able to supply an experimental COVID drug from its $425 million buyout of OncoImmune to the U.S. government under a $356 million contract as the FDA has demanded more data, delaying its supply.

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Top Stories

Gossamer Bio seeking out partners for failed DP2 antagonist, says it has 'viable path forward'

Gossamer Bio has been unraveling over the past year, hit hard by a failure for its leading drug program and the axing of its CEO Sheila Gujrathi soon after.

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Artiva, fresh from Merck pact, raises $120M for NK therapy R&D 

Artiva Biotherapeutics has raised $120 million to advance a pipeline of allogeneic natural killer (NK) cell therapies. The Merck-partnered biotech has an unmodified NK cell therapy in the clinic and a clutch of CAR-engineered candidates following close behind.

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In Partnership: Commercialization in Canada: Navigating Complex Requirements to Drive Product Success

The Canadian pharmaceutical market, which is among the 10 largest worldwide, has long been viewed as a top-tier launch destination.

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Foresite banks $969M to back companies tackling healthcare challenges highlighted by pandemic

Foresite Capital banked $969 million in its fifth and biggest raise yet to invest in companies solving some of the biggest inefficiencies in today’s healthcare system. The capital will be split into two funds: About $775 million, or 80%, will go into a core fund, while the remaining $194 million will become what the firm calls an opportunity fund.

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Genentech teams with academics for 10-year neuroscience R&D push

Genentech has partnered with the University of California (UC), San Francisco and UC Berkeley to work on neuroscience drugs. The Roche subsidiary has committed up to $53 million to collaborate with the academics on areas such as neurodegeneration over the next 10 years.

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Otsuka and Click Therapeutics tap Verily's platform for digital depression treatment study

After launching a digital health collaboration two years ago, Otsuka and Click Therapeutics are now kicking off a fully remote clinical trial to evaluate an app meant to treat adults with major depressive disorder.

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Overcoming chemotherapy resistance in leukemia with a diarrhea drug from Merck

Although acute myeloid leukemia (AML) is treatable with chemotherapy, patients often become resistant to it. Researchers at King’s College in London discovered that Merck’s drug Dificid, which inhibits the protein ABCC3, sensitized AML to treatment with doxorubicin and improved survival in mice.

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Fierce Pharma Asia—Daiichi Sankyo's new R&D head; Clover's $230M raise; Insilico's AI breakthrough

Daiichi Sankyo poached Kite Pharma's research lead to be its own. China's Clover Biopharma hauled in a $230 million series C amid its COVID-19 vaccine work. Insilico Medicine made several breakthroughs with artificial intelligence in drug discovery. And more.

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Chutes & Ladders—Moderna CMO hits exit amid COVID-19 vaccine rollout

Moderna's CMO is hitting the exit amid the biotech's COVID shot rollout. Novellus has completed its transformation into Fore Biotherapeutics, snagging a new CEO in the process. And Kite's research lead Takeshita has jumped ship to Daiichi Sankyo.

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Enrollment Showcase

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Resources

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.

eBook: Your Path to Virtualization: Eight parameters to accelerate and optimize your technology strategy

8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook.

Whitepaper: Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem.

Whitepaper: A Single Source of Truth: Acorn AI's Commercial Data Model

Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. 

Sponsored: Lessons Learned: Best IT Practices to Secure Your Remote Workforce Now

Criminals Are Actively Exploiting The CV-19 Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become A Cybercrime Statistic -- Make These Cost-Effective IT Changes Now!

Content Hub: Access resources to guide your molecule from lab to clinic

It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders.

Content Hub: Emerging Biotech Resource Center

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

Executive Summary: 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.

Research: Premier Research Resource Hub

Browse the latest learnings and insights from our clinical development professionals.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.

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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