Novo makes a play for Metsera; This week’s other big deal; Earnings in full...
Welcome back to Endpoints Weekly, and welcome to November. This week kicked off with quarterly earnings results from a handful of companies, including Eli Lilly, Merck, Novartis and Bristol Myers...
View ArticleFDA drug head Tidmarsh is put on leave, according to reports
George Tidmarsh, who leads the FDA's powerful drugs office known as CDER, has been placed on leave from the agency, according to reports. According to the New York Times, Tidmarsh had raised concerns...
View ArticleTidmarsh's exit at FDA pushes an agency in transition further toward instability
For decades, the FDA has long been thought of as a steady hand of gold-standard regulatory work for the most innovative drugs in the world. This year, the agency has looked more like a reality ...
View ArticleAmgen Ventures joins $141M Series B for Italian gene therapy biotech AAVantgarde
A Milan-based drugmaker has secured $141 million in a Series B raise backed by Amgen to develop gene therapies for two inherited retinal diseases that cause blindness. AAVantgarde Bio said it will use...
View ArticleBioNTech ups sales guidance after Bristol Myers' bispecific payment
BioNTech was able to raise its full-year guidance due to a windfall from its PD-1xVEGF bispecific collaboration with Bristol Myers Squibb. The German biotech said in its third-quarter earnings Monday...
View ArticleRoche, Manifold Bio to advance new brain shuttles in pact worth up to $2B+
As Roche kicks off Phase 3 studies for its "Brainshuttle" Alzheimer's drug, it's also hunting for the next best way to get drugs into the brain. On Monday, the Swiss pharma company announced a research...
View ArticleCaribou says it’s cracked ‘off-the-shelf’ cell therapy, but needs to raise...
Caribou Biosciences believes it has developed a ready-made CAR-T therapy that’s on par with currently available custom-made treatments for blood cancer, succeeding where other cell therapy makers have...
View ArticleTempero halts substance use disorder drug, is 'assessing strategic alternatives'
A biotech trying to disrupt substance use disorders has paused development of its Phase 2 drug and is looking for alternatives. Tempero Bio, a portfolio company of Aditum Bio, has "temporarily halted...
View ArticleAstraZeneca, Lilly, Merck contribute $120M to support manufacturing talent in...
After allocating billions to build facilities in Virginia, AstraZeneca, Eli Lilly and Merck have pledged $40 million each to help develop a manufacturing training center there. The three drugmakers...
View ArticleUniQure's Huntington's gene therapy is delayed, as FDA suggests it may walk...
UniQure's stock was in freefall Monday morning after the company announced that it might not be able to submit its Huntington’s disease gene therapy for FDA approval on the originally planned timeline....
View ArticleKimberly-Clark inks $40B+ deal for Kenvue
Kimberly-Clark plans to acquire Kenvue in a deal worth about $48.7 billion in enterprise value. The deal, which was announced Monday morning, brings together the makers of Huggies, Tylenol, Kleenex and...
View Article#ASH25: Vertex, CRISPR say Casgevy shows promise in younger children
Vertex and CRISPR Therapeutics released first data on Monday showing that their landmark gene therapy Casgevy is effective in kids under the age of 12. Casgevy was approved in 2023 for sickle cell...
View Article#ASH25: Lilly’s Jaypirca matches Imbruvica in Phase 3 early blood cancer trial
Eli Lilly has shown that Jaypirca is as good as, if not better than, Johnson & Johnson and AbbVie’s Imbruvica at shrinking certain types of blood cancer in a late-stage trial that enrolled some...
View ArticleTScan to cut a third of its staff; Iovance advances Amtagvi in lung cancer
Plus, news about Krystal Biotech, Serina Therapeutics, Rein Therapeutics, Knight Therapeutics, Kyverna Therapeutics, Roche, Alvotech, Savara and MindMed: 💼 TScan Therapeutics to lay off 66 workers: The...
View ArticleMetsera calls Pfizer threats 'nonsense' as rift widens between companies
Pfizer and Novo Nordisk's battle over obesity biotech Metsera is getting ugly. On Monday, Metsera asked the Delaware Court of Chancery to deny Pfizer's request for a hearing to determine whether to...
View ArticleUK regulators look to speed up how rare disease therapies reach the market
The UK's medicines regulatory agency said it is working to "overhaul" its framework for approving rare disease therapies. The Medicines and Healthcare products Regulatory Agency (MHRA) said on Sunday...
View ArticleLilly earmarks $3B for new European obesity pill factory
Eli Lilly plans to build another facility to make its oral GLP-1 drug orforglipron. The $3 billion site will be located in Katwijk, the Netherlands. In addition to orforglipron, the new site will make...
View ArticleAbbVie gets early win in Oklahoma 340B fight, but faces setback in Colorado
Two federal district courts have reached opposite conclusions in cases challenging states' authority to regulate how drugmakers distribute 340B discounts. An Oklahoma federal judge on Friday...
View ArticleDay after resigning, Tidmarsh now says he'll fight exit from FDA
One day after stepping down as CDER Director, George Tidmarsh has said he will fight the investigations into his conduct and is reconsidering his decision. Tidmarsh's intentions were shared with a...
View ArticleDuchenne confirmatory trial fails, but Sarepta to ask FDA for full approval...
Sarepta Therapeutics’ long-awaited confirmatory study of two of its ‘exon-skipping’ therapies for forms of Duchenne muscular dystrophy failed to meet its primary endpoint, the company announced Monday....
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