| 03.03.21 | GSK, Vir hit by weak COVID drug efficacy ; FDA demands new trial for Merck’s $425M pandemic med

Laden...

3 jaren geleden

Html
Tekst

Startup taps robots to kill brain tumors To view this email as a web page, click here

Is your Dermatology Trial Aligned with Updated Data Reporting Requirements ?

COVID-19’s impact on data reporting/CRFs for dermatology clinical trials is ongoing. Download our guide to learn what biostatistical and regulatory issues to consider for dermatology trials.

Today's Rundown

GSK, Vir hit as COVID-19 drug hopeful halted on possible weak efficacy in key NIH phase 3 Merck must do a new trial for faltering $425M COVID-19 drug the U.S. government asked it to buy Arena's pain drug fails phase 2b, prompting review of 'strategic options' Sponsored: Analysis of Humanized Mice with Myeloid Cell Engraftment Caribou nets $115M to boost CRISPR tech, advance off-the-shelf cell therapies After farming an epilepsy med out to Ovid, Takeda brings it back into the fold Janux raises $56M to take safer T-cell engagers into the clinic European VC Sofinnova Partners raises $540M late-stage crossover healthcare fund Bionaut Labs launches with plans to attack brain tumors with tiny, guided robots What does it take to supply COVID-19 vaccines across the globe? Here's how the leading players are working it

Featured Story

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

By Ben Adams

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.

Get a 3-day COA for Rapid Sterility Testing

Eurofins BioPharma Product Testing provides complete GMP rapid sterility testing in less than half the time of the compendia method, including 3 day interim results with certificate of analysis. Learn more.

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

By Ben Adams

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.

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

By Nick Paul Taylor

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.

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.

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

By Amirah Al Idrus

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.

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

By Nick Paul Taylor

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.

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

By Ben Adams

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.

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

By Conor Hale

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.

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

By Fraiser Kansteiner,Eric Sagonowsky

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.

This week's sponsor is Cobra Biologics.
	Experts in our field with 20+ years’ experience in Viral Vector & Plasmid DNA manufacture. Now part of the Cognate BioServices family, your CDMO partner from concept to commercial for cell & gene therapy products. Request a call back.

Enrollment Showcase

Specialize Your Career in Pharmaceutical Outcomes

Sponsored by: University of Florida College of Pharmacy

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

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

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

Whitepaper: Overcoming the hurdles of Real-World Data Access through a federated global network

Free Infographic: The Future of Vaccine Development

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

Sponsored By: Blue Matter, strategic consultants in the life sciences

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

Whitepaper: Seasonal Vaccine Manufacturing

Sponsored by: Baxter BioPharma Solutions

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

Content Hub: How to improve the virtual work you do every day

Content Hub: Emerging Biotech Resource Center

Executive Summary: Manufacturing Strategies to Effectively Industrialize Autologous Cell Therapies

Sponsored by: Catalent

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

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Sponsored by: Catalent

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

Sponsored by: Catalent

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

Sponsored by: Catalent

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

Sponsored by: Catalent

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.