Dan Samorodnitsky

Dan Samorodnitsky

News Editor

Dan Samorodnitsky is the news editor at BioSpace. He has a decade of experience covering biotech, genetics and medicine. Before coming to BioSpace he was an editor at Drug Discovery News and Massive Science, and his writing has appeared in outlets such as Quanta, STAT, GROW and many others. He is based in Minneapolis. You can reach him at dan.samorodnitsky@biospace.com.

The German giant is looking to develop new drugs for undisclosed eye diseases using Re-Vana’s extended-release injectable platform to supply drugs to the eye for months at a time.
The Commissioner’s National Priority Vouchers aim to offer accelerated pathways to drugs that meet certain criteria, perhaps including a low price-tag. But the policy is vaguely defined and was announced without public input, going against the FDA’s own published practices, experts say.
The collaboration focuses on ‘molecular gates,’ a class of molecules that the startup company Gate Bioscience says can stop pathogenic proteins from leaving the cell.
The company didn’t share specific data for the molecule, gefurulimab, but said it hit all endpoints in the Phase III PREVAIL trial and promised to share more at an upcoming scientific meeting.
I&I
The partnership with Matchpoint Therapeutics gets Novartis global rights on all molecules for several unannounced inflammatory diseases identified through the biotech’s discovery platform.
The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from vaccines decades ago, has long been a target of anti-vaccine advocates for unfounded links to autism and adverse health outcomes.
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
The company is pushing inhaled versions of common oral drugs with the hope of avoiding severe side effects.
Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.