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Today's Rundown

Featured Story

Intercept loses chief medical officer months after CEO stepped down

Dogged by questions over the safety of its approved liver drug Ocaliva and reeling from a rejection for the drug in fatty liver disease, Intercept has been shedding its C-suite.

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Top Stories

Clover raises $230M as COVID-19 vaccine nears phase 3, multivariant prospect gets going

Clover Biopharmaceuticals has raised $230 million to take a COVID-19 vaccine candidate into a phase 2/3 clinical trial. The series C positions the Chinese biotech to validate the efficacy of its vaccine and gear up to manufacture hundreds of millions of doses this year.

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Gene editing biotech Beam adds to drug delivery stable with $120M GuideTx buy

Not all gene editing treatments are created equal—that’s why Beam Therapeutics started out with multiple technologies from the likes of MIT, Harvard, the Broad Institute and Editas Medicine. Now, it’s adding another arrow to its drug delivery quiver with its $120 million acquisition of GuideTx, a Georgia Tech spinout.

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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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Alexion alums land at complement biotech Kira Pharma as it plots its course through the clinic

As Kira Pharma shepherds two more programs toward the clinic, the complement-focused biotech is bolstering its leadership team with a trio of biopharma veterans, including Dana Zhang, formerlythe general manager for Greater China at Alexion, where she led the approval of Soliris in China, Taiwan and Hong Kong.

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Chosen wisely: Grail, Quest team up on cancer blood test

In a gift to your headline writer, Grail has tapped testing giant Quest Diagnostics to help roll out its upcoming multi-cancer blood test.

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Altasciences buys WCCT Global, then gets snapped up itself by a pharma VC

Hot on the heels of a deal that saw Canadian CRO Altasciences buy out WCCT Global, the company was then acquired itself by Novo Holdings.

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Sanofi, Regeneron's Libtayo snags lung cancer nod, taking a stab at Keytruda's megablockbuster lead

Sanofi and Regeneron’s immuno-oncology med Libtayo is on a roll with its second FDA approval in just two weeks. The latest nod pushes the PD-1 inhibitor out of its skin cancer comfort zone and into the competitive—and lucrative—lung cancer market where Merck & Co.’s Keytruda reigns supreme.

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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.

Events