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Today's Rundown

Featured Story

GSK, German Merck's $4.2B bintrafusp alfa drug flops again, but companies squint to see glimmers of hope

Two months after GlaxoSmithKline and Merck KGaA’s oncology asset bintrafusp alfa failed to beat out King Keytruda in certain lung cancers, it has followed up with another disappointment.

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Top Stories

GBT adds 2 Sanofi sickle cell meds to its pipeline in deal worth up to $353M

As Global Blood Therapeutics works to bring its sickle cell disease drug, Oxbryta, to younger patients, the company is bolstering its pipeline with a pair of early-stage programs from Sanofi. The French pharma will receive up to $353 million in an undisclosed upfront fee and potential development, regulatory and commercial milestone payments down the line.

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Lilly's Skyrizi rival hits goal in ulcerative colitis phase 3, as it ups the ante against AbbVie

A phase 3 clinical trial of mirikizumab in ulcerative colitis has met its primary endpoint, boosting Eli Lilly’s hopes of establishing the anti-IL-23p19 antibody in gastrointestinal disorders.

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In Partnership: Meeting the challenge to deliver COVID-19 relief around the world

Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis.

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GSK kick-starts phase 3 Medicago-partnered COVID vaccine test

GlaxoSmithKline and Sanofi tripped up in a recent COVID-19 vaccine test, but the U.K. Big Pharma is hoping for better luck with its second partner Medicago.

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Alnylam clinical development vet becomes Beam Therapeutics CMO

As Beam Therapeutics sets its sights on the clinic, it has signed on a new chief medical officer. Amy Simon, M.D., arrives from Alnylam, where she held various roles over a decade, culminating in vice president of clinical development.

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Solid Bio safely doses DMD gene therapy after exiting FDA hold

Solid Biosciences has given its Duchenne muscular dystrophy gene therapy without causing the sort of adverse events that forced it to shutter the study in 2019. The experience provides early evidence that the manufacturing changes and clinical mitigation strategy could rescue the program.

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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.

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Clinical trial firms tap social media 'influencers' for virtual trial recruitment drive

As the hype around so-called siteless trials continues unabated, two trial tech firms are joining forces to tap social media influencers to help push more patients into studies.

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Resources

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.

Guide: Labs of the Future: How to choose a Lab Information Management System in 2021

Interested in moving from hand-written lab notebooks or spreadsheets to a modern research platform? Read this guide on Lab Information Management Systems (LIMS) to learn how modern companies are using software to innovate faster.

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.

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