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Today's Rundown

Featured Story

Vir, GSK COVID-19 antibody slashes hospitalizations and deaths in phase 3, spurring FDA filing plans

Vir Biotechnology and GlaxoSmithKline are stopping a phase 3 clinical trial of their COVID-19 antibody early for efficacy after seeing an 85% reduction in hospitalization or death at an interim review. The trial provided further evidence of the efficacy of anti-SARS-CoV-2 antibodies in ambulatory patients.

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Top Stories

Aelix posts HIV vaccine data ahead of Gilead combo readout

Aelix Therapeutics has presented phase 1/2a data on its therapeutic HIV vaccine candidate. Buoyed by the results, Gilead-partnered Aelix is preparing to raise cash and push into larger trials in pursuit of a functional cure for the disease.

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Lilly rejoins KRAS race with swipe at Amgen and Mirati, plans 2021 clinical trial 

Eli Lilly has rejoined the KRAS race months after toxicity forced it to dump its first candidate. The Big Pharma is set to enter phase 1 later this year with a new drug it compared favorably to rival assets developed by Amgen and Mirati Therapeutics.

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Slaoui’s Centessa adds ex-FDA commish Califf, biotech bigwigs to its board

Centessa Pharmaceuticals is adding a trio of new board members and a new chief financial officer to its roster. Gregory Weinhoff, arrives from Arvelle Therapeutics where he served as chief financial and chief business officer. Joining the board are former FDA commissioner, Robert Califf, former Tesaro chief operating officer, Mary Lynne Hedley, and CRISPR Therapeutics CEO Samarth Kulkarni.

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PhaseBio taps a manufacturing partner as it eyes 2022 filing for Brilinta-reversing drug

PhaseBio is signing a manufacturing partner for its Brilinta reversal agent as it ushers the drug through phase 3 and, it hopes, an FDA submission and approval. The company is teaming up with CDMO BioVectra to produce the treatment, bentracimab, at commercial scale.

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Roche's Actemra adds another failure to spotty COVID-19 results—this time with Gilead's remdesivir

Roche’s arthritis therapy Actemra posted another COVID-19 failure, further muddying a pool of data that has yet to offer a conclusive answer to the anti-inflammatory drug’s pandemic role. But this flop—in a combo test with Gilead's standard-of-care remdesivir—may bear more weight.

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Northwestern U's novel gene-silencing RNA drug shows promise in glioblastoma

Scientists at Northwestern University have developed a novel RNA interference drug that targets the cancer-promoting Bcl2L12 gene in glioblastoma tumors. A new study in a small number of patients showed that it can penetrate the blood-brain barrier.

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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

Content Hub: Emerging Biotech Resource Center

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

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.

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.

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.

Events