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Today's Rundown

Featured Story

J&J’s one-shot COVID-19 vaccine snags FDA staff’s backing as panel review looms

FDA staffers endorsed Johnson & Johnson's COVID-19 vaccine as safe and effective in briefing documents released (PDF) on Wednesday, ahead of an advisory committee meeting scheduled for Friday. The documents reiterated that the vaccine was 66.1% effective at preventing COVID-19 infection at least 28 days after vaccination, with “no specific safety concerns identified that would preclude issuance of an EUA.”

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Top Stories

The CRO megamerger is back as Icon snaps up PRA Health for $12B

After a flurry of CRO takeovers a few years back, the megamerger market went quiet. But, today, as the industry hauls itself out of the pandemic funk of 2020, Icon is getting out its checkbook in a massive $12 billion buyout of PRA Health.

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Orna Therapeutics debuts with $100M, engineered circular RNA treatments to rival cell therapies

Multiple companies aim to surmount the limitations of CAR-T therapy by going beyond T cells and engineering cell therapies based on natural killer cells or macrophages instead. Orna Therapeutics’ solution is more holistic: bringing CARs directly to a patient’s immune cells to help them kill cancer. The company uncloaks with $100 million to develop this approach, among others, all of which are based on engineered circular RNA.

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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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UCB taps Microsoft to accelerate drug discovery, clinical trials

UCB and Microsoft have entered into a multiyear strategic collaboration. The deal will see Microsoft use its capabilities in computational services, cloud computing and artificial intelligence to support drug discovery and development at UCB.

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Sanofi, following Denali, pens gene therapy pact with Sirion Biotech

French Big Pharma Sanofi is teaming up with Germany’s Sirion Biotech for its viral-vector-based gene delivery tech.

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Xilio raises $95M to take twists on Yervoy and IL-2 into clinic 

Xilio Therapeutics has raised $95 million to take IL-2 and CTLA-4 immunotherapies into clinical trials. The series C positions Xilio to provide early clinical validation of anti-cancer agents that are designed to remain inactive until they reach tumors. 

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Breaking Big Pharma's AI barrier: Insilico Medicine uncovers novel target, new drug for pulmonary fibrosis in 18 months

Insilico Medicine's computer networks uncovered a never-before-tried biological target linked to idiopathic pulmonary fibrosis and designed a novel molecule from scratch to potentially treat the disease—for less than $2 million and 18 months of time.

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Enrollment Showcase

Specialize Your Career in Pharmaceutical Outcomes

Learn about the Top 5-Ranked UF College of Pharmacy’s online graduate programs in pharmaceutical outcomes & policy. Select from five specializations, including the new pharmaceutical value assessment & communication option. Over half of graduates progress to a new role within one year. Register now.

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