Roche plans to pit next-gen hemophilia A antibody against Hemlibra in Phase 3
Roche is moving its next-generation hemophilia A treatment into Phase 3 testing next year after seeing the early-stage data. The pharma disclosed Monday that part of the Phase 3 program will ...
View ArticleFDA approves AstraZeneca, Daiichi Sankyo's Datroway in EGFR-mutated lung cancer
The FDA on Monday approved AstraZeneca and Daiichi Sankyo’s TROP2-targeting drug Datroway in a new lung cancer indication, broadening the amount of patients for what the company hopes is their next big...
View Article#ADA25: Amgen plans more gradual MariTide dosing in Phase 3
Amgen intends to dose its long-acting obesity shot MariTide at a lower level in its Phase 3 than it did in Phase 2, after the drug’s side effects proved unmanageable in mid-stage research. The adverse ...
View ArticlePolitics collide with science ahead of new ACIP meeting
A newly-rebuilt CDC vaccine advisory panel will meet for the first time this week, informing whether the US' public health agency will continue to back data and evidence that have long guided its...
View ArticleNuvalent closes in on FDA filing for lung cancer drug with topline Phase 1/2...
Nuvalent has shared positive data for its ROS1 inhibitor from a “pivotal” mid-stage lung cancer study, and plans to start a rolling NDA submission next month. The biotech’s candidate, called...
View ArticleUK government blueprints ambition to be a key life sciences hub
The UK government has provided big picture plans to help it reach its target of becoming the leading life science center in Europe by 2030 and the third in the world by 2035, behind the ...
View ArticleArriVent plots next steps for lung cancer drug; Neuron23's $96.5M raise
Plus, news about Rivus, Amarin, Recordati, Liquidia, Healthcare Royalty, Lexeo, Perceptive, venBio, Novo Nordisk and Cidara: ArriVent to start another Phase 3 of lung cancer drug: In a Phase 1b trial,...
View ArticleNektar reports positive Phase 2b rezpeg data in eczema, stock skyrockets
Nektar Therapeutics is blazing a comeback trail for a drug it once worked on with Eli Lilly, trumpeting positive Phase 2b data on Tuesday that Wall Street found exceptional. Nektar said...
View ArticleRevolution secures up to $2B from Royalty Pharma in custom funding deal
Revolution Medicines has signed a “flexible funding agreement” with Royalty Pharma for up to $2 billion that should support it through late-stage development of its lead RAS inhibitor and beyond. The...
View ArticleSources: FDA chief Makary sought rejection of KalVista's drug
Multiple agency sources said FDA Commissioner Marty Makary was behind a short-lived request last week to reject a rare disease drug application from KalVista Pharmaceuticals that remains under agency...
View ArticleFormer Pfizer CSO Mikael Dolsten joins board of gene editing startup
Mikael Dolsten, Pfizer's former chief scientific officer who led the company’s Covid-19 vaccine development, has joined the board of Arbor Biotechnologies, a gene editing startup working on therapies...
View ArticleNovo and Hims' crossed wires
Back in April, I was surprised (and skeptical) when Hims said it was teaming up with Novo Nordisk to offer its members discounted Wegovy — just the start of a long-term collaboration with the pharma...
View ArticleRFK Jr. refutes that he guaranteed to keep ACIP's roster
A day after Sen. Bill Cassidy (R-LA) called for a delay to this week’s Advisory Committee on Immunization Practices meeting, HHS chief Robert F. Kennedy Jr. said he did not guarantee to preserve the...
View ArticleFDA hires former FDA scientist Michael Davis as CDER deputy director
The FDA is bringing back Michael Davis as the next deputy director of the Center for Drug Evaluation and Research, according to an internal memo viewed by Endpoints News. Davis’ hiring comes a day...
View ArticleRFK Jr. to Congress: US will remain at the center of the biotech world
HHS Secretary Robert F. Kennedy Jr. on Tuesday promised that the US will remain the leader in biotech innovation, even as China has added "huge amounts of money into this space." Speaking before the...
View ArticleFDA investigating Sarepta’s Duchenne gene therapy following patient deaths
The FDA announced Tuesday that it is looking into deaths due to liver failure following the administration of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy ...
View ArticleBiogen unveils first spinal muscular atrophy data from Spinraza follow-on
Biogen shared that its next-generation spinal muscular atrophy RNA drug improved measures of neurodegeneration and motor function in an initial cut of data, and the company is planning to move the...
View ArticleBayer's BlueRock prioritizes neurology, eye programs, lays off about 50 staffers
Bayer subsidiary BlueRock Therapeutics is cutting back on some of its cell therapy work and laying off several dozen staffers. The company will restructure itself to support their neurology and...
View Article#ADA25: BrightGene seeks a partner for Zepbound-beating obesity shot
A Shanghai-based biotech, previously known as a generics and manufacturing player, posted mid-stage results suggesting its incretin drug might be one of the most powerful to have reached the clinic....
View ArticleArbutus regains rights to hepatitis B asset in China; Forte’s $75M offering
Plus, news about the Novo Nordisk Foundation, Assembly Biosciences, Cidara Therapeutics, Minovia and Celyad Oncology: Arbutus reacquires China rights to hepatitis B candidate: The company licensed the...
View ArticleKymera inks deal with Gilead as partnership with Sanofi faces a switch-up
Gilead has enlisted Kymera Therapeutics to develop a compound that it hopes can be part of the next wave of targeted breast cancer treatments. The partnership, which was announced Wednesday, centers ...
View ArticleTrump’s CDC nominee sidesteps Senate grilling on controversial changes
The Senate confirmation hearing for Susan Monarez, President Donald Trump’s second nominee for the next CDC director, featured few fireworks as she dodged questions about recent political moves at the...
View ArticleACIP will reassess cumulative vaccine effects, older shots
The newly reconstructed CDC vaccine advisory panel will examine the cumulative effects of the childhood vaccine schedule, in addition to shots that members say haven’t been reviewed in “more than seven...
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