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Past and present FDA adcomm members weigh in on potential reforms
A majority of former and current FDA advisory committee members surveyed in July supported remote participation in meetings and better communication, as the FDA considers reforms to its committees of...
View ArticleLilly opens huge new Boston research center, with a focus on genetic medicines
BOSTON —The world’s most valuable drugmaker is finally opening its doors in the country’s biggest biotech hub. Eli Lilly officially opened its gleaming new 12-story research center in Boston on...
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Acelyrin sheds pipeline, lays off 33% of staff three months after CEO departure
Acelyrin is in the rough. The drug developer that deployed a strategy of in-licensing or acquiring “diamonds in the rough” is now facing a harsh reality and halting most plans on its lead late-stage...
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To get back to growth, Illumina CEO says it's simplifying DNA sequencing and...
On Tuesday, Illumina laid out a three-year plan for investors detailing how the struggling DNA sequencing company plans to get back to growth. To do so, its CEO said, the company is making it easier...
View ArticleIn bid to save cash, Grail says it will cut 350 jobs and focus on...
The cancer diagnostics company Grail announced Tuesday that it plans to cut 30% of its workforce to reduce expenses, just weeks after being spun out of Illumina as an independent company. In addition...
View ArticleAstraZeneca's Imfinzi, Lynparza combo approved in EU for certain endometrial...
Two of AstraZeneca’s top cancer treatments have been approved in combination to treat a subgroup of endometrial cancer patients in the European Union, the drugmaker announced Wednesday morning. The...
View ArticleMetagenomi tinkers with pipeline after CSO departure, says Affini-T and Ionis...
In the first two quarters since going public, Metagenomi’s tie-up with Moderna ended, the California startup’s chief scientific officer departed and now the preclinical biotech’s pipeline has been...
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Avenge Bio, a cell therapy biotech from Rice, is closed
Cell therapy startup Avenge Bio has shut down, Endpoints News has learned. Chris Garabedian The company ceased all operations and sold its lead asset, Xontogeny CEO Chris Garabedian told Endpoints in...
View ArticleAnother offering for Avidity; Galera shuts down
Plus, news about Kezar Life Sciences, Elicio Therapeutics and Viracta Therapeutics: Avidity seeks $250M in public offering: The money will be used in part to advance its pipeline, Avidity said. Last...
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Evotec to cut 400 workers and close sites, citing ‘no new signals of...
Evotec plans to lay off 400 workers and shutter facilities as the German manufacturer and biotech continues to grapple with pharma’s cutback on R&D activities, causing the company to lay off 400...
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Verrica’s stock dips despite Phase 2 skin cancer drug clearing more than 50%...
Verrica Pharmaceuticals’ oncolytic peptide that could help eliminate or ease the burden of surgery in basal cell carcinoma has shown signs of efficacy in a mid-phase study. In a secondary endpoint in a...
View ArticleSanofi backs AnaptysBio’s $100M offering, helping catapult the biotech’s stock
AnaptysBio is riding Wall Street momentum, reporting its highest share price in almost five years after a $100 million offering that brought Sanofi aboard. The immunology-focused biotech courted the...
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FDA gives accelerated approval to PBC drug at the center of Gilead’s $4.3B...
Six months after buying CymaBay Therapeutics for $4.3 billion, Gilead has secured accelerated approval for seladelpar, the primary biliary cholangitis drug that was at the heart of the takeover. The...
View ArticleInvestment in early-stage health tech startups climbed in the first half of...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Health tech investors have been pouring money into early-stage startups as more mature companies with...
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Arrowhead lays out early-stage obesity strategy, including new target on...
Arrowhead Pharmaceuticals unveiled a new RNAi-based obesity program on Wednesday that it believes could be “gentler” than currently available GLP-1 products. The target, ALK7, is a receptor on the...
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Bluebird's slow sickle cell launch forces rework of loan, putting cash runway...
Bluebird bio reported Wednesday that just four patients have started the process for receiving its sickle cell therapy Lyfgenia, endangering a $50 million loan that the pioneering yet cash-strapped...
View ArticleFDA warning letter targets doctor who worked on a Takeda Phase 3 study
Back in January, Takeda won approval for a new indication for its primary immunodeficiency drug HyQvia, this time as a treatment for a rare autoimmune disorder called chronic inflammatory demyelinating...
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Incyte gets another graft-versus-host disease drug approval, this time with...
Incyte and partner Syndax Pharmaceuticals on Tuesday secured regulatory clearance to market a third-line chronic graft-versus-host disease treatment, or cGVHD. The agency greenlit the duo’s axatilimab,...
View ArticleZealand joins next-gen club aiming to ‘accelerate’ obesity drug development
As next-generation contenders in the obesity treatment space communicate plans to speed up their drug programs, Zealand Pharma appears to have gotten the memo. The Danish biotech is raising its...
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Biden administration says IRA negotiations will result in $6B in 2026...
The first round of negotiations under the Inflation Reduction Act will save Medicare $6 billion in 2026, the Biden administration announced Thursday. The final prices will be released later today for...
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