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Today's Rundown

Featured Story

GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3

GlaxoSmithKline and partner Vir have seen a key, late-stage test of their experimental COVID drug stopped for new patients amid concerns it may not be working well enough.

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Top Stories

Merck must do a new trial for faltering $425M COVID-19 drug the U.S. government asked it to buy

It’s already had to give up on any hopes of creating a vaccine against COVID-19, and now Merck is being told that its pandemic drug hopeful will need another trial before it can be issued a green light.

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Arena's pain drug fails phase 2b, prompting review of 'strategic options'

A phase 2b clinical trial of Arena Pharmaceuticals’ olorinab has missed its primary endpoint. The cannabinoid receptor 2 agonist failed to reduce abdominal pain in the overall population of irritable bowel syndrome patients, but Arena pointed to a subgroup analysis as evidence of efficacy.

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Sponsored: Analysis of Humanized Mice with Myeloid Cell Engraftment

Humanized immune system mice are revolutionary tools for the development of oncology therapeutics, but their use has been limited for some applications by impaired human myeloid cell differentiation.

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Caribou nets $115M to boost CRISPR tech, advance off-the-shelf cell therapies

On the heels of a new partnership with AbbVie, Caribou Biosciences is reeling in $115 million to keep improving its CRISPR technology and shepherd its pipeline of allogeneic, or off-the-shelf, cell therapies into and through the clinic.

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After farming an epilepsy med out to Ovid, Takeda brings it back into the fold

Takeda struck an unusual deal with Ovid Therapeutics in early 2017: instead of a Big Pharma snapping up a promising asset from a small biotech, it was Ovid that would help Takeda develop a drug for a group of rare epilepsies. Now that Ovid has taken the program through phase 2, Takeda is taking back its global rights—to the tune of $196 million.

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Janux raises $56M to take safer T-cell engagers into the clinic

Janux Therapeutics has raised $56 million to fund development of T-cell engagers. The series A will fund preclinical work on TROP-2 and PSMA candidates, positioning Janux to enter the clinic next year.

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European VC Sofinnova Partners raises $540M late-stage crossover healthcare fund

Sofinnova Partners has pulled in a healthy €445 million ($540 million) in its latest capital raise as the European venture capital firm seeks out late-stage plays in biotech and medtech.

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Bionaut Labs launches with plans to attack brain tumors with tiny, guided robots

The robots are coming: After working under the radar for four years, Bionaut Labs is raising the curtain on its tiny, remote-controlled devices, built to travel through the human body and deliver a dose of medicine where it’s needed the most.

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What does it take to supply COVID-19 vaccines across the globe? Here's how the leading players are working it

As COVID-19 gained steam worldwide last spring, little was known about the disease and the havoc it would wreak on the world. A year later, vaccines offer hope in the global effort to end the pandemic, but it will be a monumental task to produce them and deliver them around the world.

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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

Guide: How to maximize your drug commercialization investments

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

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

Download our whitepaper to learn how BC Platforms has leveraged our technical expertise to offer robust and comprehensive solutions to maximize RWD ROI.

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.

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