Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand
French vaccine maker Valneva is laying off 10% to 15% of its workforce and reducing revenue projections due to "an emerging adverse trend in travel vaccine uptake across key markets." The drugmaker
View ArticleTakeda to target 4,500 jobs as incoming CEO continues restructuring
Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in ...
View ArticleAfter an apparent cure, a gene editing company struggles to repeat the magic
BOSTON — Early last year, startup iECURE’s experimental gene therapy seemingly cured a baby of a life-threatening genetic disease. But new results testing the same therapy in a larger number of babies...
View ArticleBeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of...
View ArticleRegenxbio hits Duchenne gene therapy milestone, eyes 2027 FDA approval
Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027. The biotech hopes to be the second company to...
View ArticleBiogen's anti-tau Alzheimer's drug misses Phase 2 goal, but claims signs of...
Here we go again? Biogen reported heavily anticipated Alzheimer’s data, saying its tau-targeting drug BIIB080 missed its primary endpoint in a Phase 2 study but slowed patients’ clinical decline at all...
View ArticleHow Penn Medicine plans to use AI to train their doctors
Physicians at Penn Medicine said they're thinking of how to use AI to train doctors. The idea came out of a $1.1 million grant Penn Medicine won in January through an education grant program with ...
View ArticleMacroGenics sells manufacturing arm; West Pharma discloses cybersecurity attack
Plus, news about Bavarian Nordic and OrganaBio’s new CDMO subsidiary: 🏭 Bora buys MacroGenics' manufacturing operations: MacroGenics is selling its clinical and commercial drug substance production...
View ArticleAstraZeneca follows Merck with Phase 3 win in bladder cancer
A combination of AstraZeneca's Imfinzi with Pfizer and Astellas’ Padcev kept more bladder cancer patients alive than standard of care, the company said Thursday. AstraZeneca said it would seek approval...
View ArticleDegron, CREATE, TenNor raise capital; Cabaletta posts CAR-T data
💸 A Series A extension: US-China biotech Degron Therapeutics has collected an additional $40 million for its molecular glue degrader platform. The San Diego and Shanghai biotech has raised $95 million ...
View ArticleDrugmakers have to go through rigorous tests to get a lower tariff rate
Landing a reduced 20% tariff rate will require pharma companies to fill out extensive paperwork and be closely monitored by the Department of Commerce. President Donald Trump signed an executive order...
View Article#ASGCT26 dispatch: In vivo CAR-T is everywhere
BOSTON — Greetings from Boston, where I’ve been on the ground covering the American Society of Gene & Cell Therapy’s annual meeting all week. It’s a crucial moment for the field. Genetic medicine...
View Article#ASGCT26: Encoded's gene therapy reduced seizures in Dravet syndrome
A gene therapy designed by Encoded Therapeutics reduced seizures by 76% in children with Dravet syndrome, a severe neurodevelopmental disorder. The remarkable reduction was observed only in three...
View ArticleSupreme Court preserves mail access for abortion pill
The Supreme Court will continue to allow the abortion pill mifepristone to be distributed by mail, at least for now. The Thursday ruling maintains mifepristone's current safety protocols while...
View Article#ASGCT26: A Zillow-like marketplace for abandoned gene therapies goes live
BOSTON — Two nonprofit organizations have devised a plan to help abandoned cell and gene therapies find a new home. On Thursday, the American Society of Gene & Cell Therapy (ASGCT) and the Orphan...
View ArticleAndrea Pfeifer ends 23-year reign at AC Immune; Acadia's top R&D exec...
AC Immune will be searching for a new CEO for the first time, as the company announced this week that Andrea Pfeifer plans to retire after 23 years at the helm. ...
View ArticleM&A isn’t just for big pharma. Mid-size companies are stepping up deal hunts
In what is shaping up to be one of the most active years for biopharma M&A on record, a different-looking set of buyers is going shopping. Mid-cap American drugmakers, family-owned pharma groups,...
View ArticleAardvark's next move after clinical hold; Alumis' verdict on Acelyrin asset
Plus, news about Tenaya’s TN-401 and Taiho’s Inqovi. 📉 Aardvark to unblind rare disease trial following clinical hold: The FDA has placed a full clinical hold on the company's candidate for ...
View ArticlePost-Hoc Live: Makary's out at FDA and what comes next
Marty Makary resigned as FDA commissioner on Tuesday after a turbulent tenure at the head of the agency. Makary was scheduled to sit down with senior reporter Max Bayer this week at ...
View ArticleCandel reports prostate cancer drug's long-term data ahead of FDA filing
Candel Therapeutics produced long-term follow-up data that may bolster the case for its prostate cancer drug that's heading to the FDA for marketing approval later this year. The company followed up...
View ArticleAmgen expands crackdown on what it says is misuse of 340B program
Amgen is expanding its claims data requirements for pharmacies dispensing its drugs under the 340B federal drug discount program. The company said the new policy addresses what it claims is fraud and...
View ArticleBiopharma M&A maintains strength even as large deals wane
Biopharma's deals landscape could hardly be better, as large companies take a multi-pronged approach to withstand an avalanche of major patent expiries. But there’s one notable missing piece:...
View ArticleCDER chief Høeg fired from FDA as other top roles turn over
The leader of the FDA's drug division, Tracy Beth Høeg, is expected to depart the agency, as part of a broad shakeup at the top of the agency after the exit of now-former commissioner Marty ...
View ArticleMakary resigns; Biogen reports Alzheimer’s data; and more
Welcome back to Endpoints Weekly. The biggest news this week was Marty Makary’s resignation from his role as FDA Commissioner. The announcement came days after reports emerged that President Donald...
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