Clik here to view.
House committee presses FDA center directors on domestic manufacturing, LDTs
The House Energy & Commerce’s subcommittee on health heard from the directors of the FDA’s device, biologics and drug centers on Wednesday for a “check up.” Representatives peppered the officials...
View ArticleAGC Biologics, BioConnection forge partnership to be an alternative to WuXi...
Two manufacturers are joining forces to court biopharma companies looking for service providers outside of China. CDMO AGC Biologics and CMO BioConnection said on Wednesday they are partnering to offer...
View ArticlePfizer announces another $1.5B in cost cuts — and plans for more to come
Months after beginning a $4 billion savings strategy, Pfizer is planning on a new $1.5 billion round of cost cuts, as well as what are likely to be more reductions in the future. The cuts include...
View ArticleFDA questions hypoglycemia risk for Novo Nordisk's once-weekly insulin ahead...
The FDA is raising concerns about increased rates of hypoglycemia following treatment with Novo Nordisk’s experimental once-weekly basal insulin ahead of an advisory committee meeting on Friday. In...
View ArticleClik here to view.
Merck KGaA makes $600M bet to boost manufacturing for viral vectors
Merck KGaA announced Wednesday that it is acquiring Mirus Bio, a startup that develops transfection reagents for viral cell and gene therapies, for $600 million. “Combining Mirus Bio’s leading...
View ArticleFederal appeals court sides with drugmakers on 340B limitations
A federal appeals court ruled on Tuesday that drugmakers are not restricted from setting contractual limits on the distribution of discounted drugs under a federal drug discount program known as 340B....
View ArticleClik here to view.
Takeda enters hot molecular glue space in up to $1.2B pact with Degron
Takeda is adding the popular “molecular glue” approach to its R&D capabilities in an up to $1.2 billion collaboration with a young biotech. The Japanese drugmaker, which is undergoing a broad...
View ArticleGrey Wolf reels in $50M to expand into autoimmune diseases
Grey Wolf Therapeutics raised another $50 million, which is set to extend its runway through 2026 and fund another clinical trial, this time in autoimmune diseases. The additional financing arrives as...
View ArticleReNAgade is acquired by RNA rival a year after megaround-backed launch
Two buzzy, well-funded biotech startups are combining in a bid to create a powerhouse at the bleeding edge of genetic medicines. Orna Therapeutics announced Thursday that it would acquire ReNAgade...
View ArticleAstraZeneca makes license and option deal with Nona Biosciences for $19M upfront
AstraZeneca on Thursday inked a license and option deal with the US offshoot of a Chinese-Dutch company, with an eye to creating antibody-based targeted cancer treatments. The UK pharma will pay Nona...
View ArticleClik here to view.
Startup launches with ‘RNA sensor’ technology from Stanford and MIT to better...
Finding a way to deliver genetic medicines to the right parts of the body is one of the most technologically vexing problems in the biotech industry. Many companies grappling with the issue are trying...
View ArticleClik here to view.
Exclusive: Senior primary care startup Gather Health has raised $16M in a new...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Gather Health, a primary care company headed by a former VillageMD executive, has raised $16.3 million in...
View ArticleAtropos Health raises $33M to arm doctors and pharma companies with evidence
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) With $33 million in fresh funding, Atropos Health — a startup using data from past patients’ cases to...
View ArticleChinese CDMO takes over Pfizer’s UK facility; Serum Institute ships malaria...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Asymchem Laboratories will take over operations at Pfizer’s API...
View ArticleClik here to view.
SR One raises $200M+ for third fund, still with GSK support
SR One, a life sciences venture capital firm that years ago split from GSK, has raised more than $200 million for a growth opportunities fund, it told Endpoints News. Jake Nunn The fund is a “natural...
View ArticleBicycle’s $555M placement; Tango Therapeutics scraps cancer program
Plus, news about Sanofi, XGEN Ventures, Owkin and Idorsia: Bicycle Therapeutics to raise $555M in one of the biggest PIPEs of the year: The company’s stock $BCYC was up 20% on Thursday morning after it...
View ArticleMerck KGaA avoids prosecution after cooperating with DOJ to uncover China...
Merck KGaA’s subsidiary MilliporeSigma has evaded charges from the US Department of Justice after exposing an alleged eight-year scheme by a former employee and his accomplice to illegally ship...
View ArticleCytokinetics CEO defends Royalty Pharma deal: 'That narrative was hijacked'
Cytokinetics CEO Robert Blum blamed investor frustration over a deal with Royalty Pharma on a “hijacked” narrative that the company would be better off selling itself than continuing on its own. On...
View ArticleClik here to view.
Hornet Therapeutics revives former Kyowa Kirin cancer drug for...
Hornet Therapeutics is on a mission to prevent and treat conditions related to the Epstein-Barr virus (EBV) with the help of a drug candidate shelved by Kyowa Kirin. With $5 million in seed funding...
View ArticleEuropean Commission finalizes joint clinical assessment rules for member...
The European Commission on Thursday finalized rules on how it pools expertise from across the EU to assess the effectiveness of new drugs when compared to drugs already on the market. The rules are...
View Article