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Today's Rundown

Featured Story

Gilead poaches Amgen exec Flavius Martin to run its R&D as 30-year veteran Bill Lee retires

Gilead Sciences has nabbed Amgen’s leading research exec Flavius Martin, M.D., to run its R&D organization.

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Top Stories

Vir, GSK race COVID-19 antibody to FDA for emergency nod

Vir Biotechnology and GlaxoSmithKline have asked the FDA for emergency use authorization for their coronavirus-fighting dual-action antibody. The duo is seeking an emergency OK for the treatment of adults and adolescents aged 12 and older with mild to moderate COVID-19 who are at risk of dying from or needing hospitalization.

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As Alkermes shines light on early cancer, neuro assets, biotech searches for collabs, strategic ops

Alkermes’ virtual R&D day went down well with analysts, as it showed off a few early-stage incremental updates and reiterated its attempts for seeking out some new ops and collabs.

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Sponsored: NK Cells are Now Better Serial Killers

Could native, non-functioning NK cells in cancer patients be rescued and revived by a novel, off-the-shelf immuno-oncology therapeutic that is also a pervasive serial cancer killer? The Data Says Yes.

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British T-cell cancer biotech Achilles Therapeutics guns for $176M IPO

Achilles Therapeutics is looking for a meaty $176 million initial public offering for its next-gen immuno-oncology work.

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Gyroscope bags $148M for AMD gene therapy trials, mulls IPO

Gyroscope Therapeutics has raised $148 million to advance a pipeline of ocular gene therapies. The series C, which could be a precursor to an IPO, positions Gyroscope to build on recent early-phase data on lead candidate GT005.

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AstraZeneca partner takes nasal COVID-19 vaccine into phase 1

The University of Oxford has begun a phase 1 clinical trial of a nasal spray formulation of its AstraZeneca-partnered COVID-19 vaccine. 

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Fierce Pharma Asia—Takeda's Anima mRNA translation pact, China digital health incubator; Daiichi's COVID-19 vaccine

Takeda taps Anima Biotech to develop mRNA translation modulators for neurologic disorders. The Japanese pharma's China branch launched a digital health incubator. COVID-19 vaccine latecomer Daiichi Sankyo moved its mRNA candidate into a human trial. And more.

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Chutes & Ladders—GSK, Centessa part ways with Slaoui over sexual harassment allegations

GlaxoSmithKline and Centessa Pharmaceuticals cut ties with Moncef Slaoui after an employee raised allegations of sexual harassment that occurred several years ago at GSK. AlloVir nabbed Gilead Sciences' virology lead Diana Brainard as its new CEO. Merck has tapped longtime insider Caroline Litchfield as chief financial officer.

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Resources

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.

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.

Whitepaper: Roche to pick up GenMark Diagnostics in $1.8B infectious disease testing deal

Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously.

Content Hub: Emerging Biotech Resource Center

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

Annual Report: Clinical Trial Landscape In Russia and Eastern Europe, 2020.

Find out why more than 400 clinical trials annually are initiated in Russia by US and EU pharma in the free annual report by OCT Clinical.

Report: State of the Industry Report: Embracing Trial Change and Elevating IRT Systems

This industry report reveals qualitative and quantitative candid insight from clinical development insiders and their views on current clinical trial challenges faced amidst uncertainty.

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. 

Guide: How to maximize your drug commercialization investments

Unlock product potential by making the most of your commercialization investments. 

Whitepaper: New Data: A Better Way to Run CHO Cell Culture Experiments

Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly.

eBook: Optimize Trial Performance with AI-enabled Technology & Advanced Analytics

Unlock competitive advantage with AI and advanced analytics.

Whitepaper: The Crush: How COVID-19 Is Impacting Mature Brand Revenue & Long-Term Value

Mature brands lost billions in revenue and value during COVID, but with the right strategy, pharma can rebound and reignite revenue. Learn How.

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.

Free Infographic: The Future of Vaccine Development

Involved in vaccine development? Check out this timely infographic detailing the history of vaccines, key development milestones, and what challenges remain.

Whitepaper: 2021 Outlook for Cell-Based Therapies in Oncology: CAR-T Expansion & Beyond

A look ahead at how cell-based therapies in oncology will advance during 2021-22: research, regulatory, and commercial milestones.

Whitepaper: Seasonal Vaccine Manufacturing

While service directories are filled with CMOs claiming vaccine fill-finish experience, the logistical challenges resulting from seasonal product are unique and it is important that outsourcing partners can ensure quality and on-time delivery.

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.

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.

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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