FDA advisors call for better studies of immunotherapy around lung cancer...
Pharma companies developing treatments for lung cancer should design more nuanced clinical trials that can provide better data about how the drugs are used in combination with surgery, a panel of...
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Updated: With cost-cutting underway, Bristol Myers raises guidance, touts...
Bristol Myers Squibb reported a Phase 3 success and a pipeline cut as part of its second-quarter earnings Friday morning. The company said a pivotal trial for cendakimab, an anti-IL-13 monoclonal...
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Westlake's non-opioid pain startup Latigo gets new leader; Ron Cooper lands...
Nima Farzan Nima Farzan has joined pain company Latigo Biotherapeutics after leaving Kinnate Biopharma, which was sold to XOMA Corporation in April. Latigo emerged earlier this year with $135 million...
View ArticleFDA approves Sun Pharma's JAK inhibitor Leqselvi for hair loss in adults
Sun Pharma’s $576 million acquisition of Concert Pharmaceuticals is paying off with an FDA approval of the alopecia drug that came with the 2023 deal. The agency approved the tablet Leqselvi...
View ArticleCalliditas claims mid-stage win for rare liver disease drug
Calliditas Therapeutics’ NOX enzyme inhibitor succeeded in a Phase 2b trial in people with a rare liver disease that features inflammation and injury in the bile ducts. In the placebo-controlled...
View ArticleEuropean drug regulator rejects Eisai and Biogen's Alzheimer's drug Leqembi,...
The European Medicines Agency on Friday held its ground against anti-amyloid treatments, saying it will not recommend Eisai and Biogen’s Alzheimer’s drug Leqembi for approval. The decision, according...
View ArticleProMIS announces PIPE up to $122M; Confo raises €60M in Series B
Plus, news about Innovent Biologics and Acticor: ProMIS Neurosciences inks $122.7M placement after sharing Alzheimer’s data: The biotech said its amyloid beta monoclonal antibody was safe and crossed...
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Cue Biopharma prioritizes autoimmune pipeline, axes a quarter of staff to...
To extend its cash reserves, Cue Biopharma is shifting focus away from its oncology assets and will zero in on its autoimmune disease pipeline instead. The biotech is also slashing its workforce by...
View ArticleAndrew Left, Citron Research short seller who campaigned against Valeant, is...
For years, Andrew Left and his short-selling fund Citron Research were a swashbuckling presence on social media, accusing companies of fraud and misdeeds, and making stock bets that he was right. On...
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Bristol Myers restarts radiopharmaceutical Phase 3 trial, but delays readout...
Bristol Myers Squibb has resumed recruitment for its lead radiopharmaceutical trial after an isotope shortage forced a pause earlier this year, chief medical officer Samit Hirawat said on the company’s...
View ArticlePfizer and BioNTech say GSK's Covid patent suit is 'groundless'
Pfizer and BioNTech have called GSK’s patent lawsuit “groundless,” accusing the British drugmaker of “improperly contorting” its claims to say their blockbuster Covid vaccine is covered by GSK patents....
View ArticleAmong pharma CEOs, the IRA now and the IRA later get very different reactions
Pharma has a message to investors about the results of the first round of drug price negotiations under the Inflation Reduction Act: It’s fine. Over the last two weeks, many of the drugmakers subject...
View ArticleCompounded weight loss drugs have resulted in misdosing, hospitalizations,...
The FDA on Friday alerted healthcare providers and the public that it’s seeing reports of unintended overdoses of the compounded version of self-injected weight loss drug semaglutide, which can be...
View ArticleMapping GLP-1 game plans; Q2 earnings highlights; J&J vets regroup at...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticlePfizer cuts 210 North Carolina workers after it officially discontinues...
Pfizer will end development on its experimental Duchenne muscular dystrophy gene therapy after a Phase 3 failure last month, and plans to eliminate roles at a North Carolina site that was working on...
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Roivant's dealmaker lands $81M cash bonus following drug sale to Roche
One of the best pharma deals in recent history has now led to one of the industry’s biggest-ever executive paydays. Roivant awarded its top dealmaker Mayukh Sukhatme an $80.55 million cash bonus,...
View ArticleIndivior reaches $86M settlement over its alleged role in the opioid epidemic
Indivior will pay $86 million over five years as part of a settlement with 17 states over it’s alleged role in the opioid epidemic, New York Attorney General Letitia James announced last week....
View ArticleAstraZeneca and Daiichi Sankyo fail to win NICE recommendation for Enhertu,...
The United Kingdom’s drug pricing watchdog has officially declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu for HER2-low breast cancer in the UK, noting that the companies were “unwilling”...
View ArticleBessemer VC Morgan Cheatham shares how AI healthcare startups can win in a...
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Among what seems like a gazillion startups using AI to solve administrative problems for healthcare...
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Roche begins Phase 2 obesity trial for GLP-1/GIP agonist CT-388
Roche said it would step on the gas pedal to catch up to Novo Nordisk and Eli Lilly (plus many other hopefuls) in obesity. And it has. The Swiss pharma conglomerate has kicked off a Phase 2 trial of...
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