Calliditas 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...
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#AAIC24: Anavex’s new analysis of its Alzheimer’s pill shows mixed results
PHILADELPHIA — Twenty months ago, the small biotech company Anavex announced that an experimental pill for Alzheimer’s disease helped slow cognitive decline on three common tests used to study the...
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vTv Therapeutics' diabetes drug program hit with clinical hold from FDA
The FDA has handed down a clinical hold to vTv Therapeutics’ lead diabetes program, halting a Phase 3 trial for the oral small molecule candidate. The North Carolina-based company announced that it...
View ArticleAstraZeneca’s fixed-duration Calquence combo succeeds in Phase 3 chronic...
When given with other cancer drugs for a limited time, AstraZeneca’s Calquence hit the primary endpoint in a registrational test, which could open up a bigger opportunity for the blockbuster drug in...
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Updated: GSK and Flagship to create up to 10 vaccines, medicines across...
GSK and Flagship Pioneering will jointly pay up to $150 million to kick-start a respiratory and immunology tie-up. The pair will create new vaccines and medicines based on work out of Flagship’s...
View ArticleWuXi AppTec sees US revenue decline amid Biosecure threat
WuXi AppTec saw a slight drop in revenue and a bigger fall in profit in the first half of 2024, with US revenue dipping as the company remains a political target for American lawmakers. Despite the...
View ArticleNewAmsterdam succeeds in the first of three key pivotal studies, providing...
NewAmsterdam Pharma aced the first in a cascade of Phase 3 readouts, showing that its lead cardio medicine took down levels of bad cholesterol. The positive results, if they bear out in future...
View ArticleCollegium pays $525M to buy ADHD company; FDA delays Syndax decision
Plus, news about Cipher, ParaPRO, Viracta, ReviR Therapeutics and Luye Pharma: Collegium’s $525M acquisition: The pain biotech plans to pay that amount, plus a potential $25 million in commercial...
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#AAIC24: Cognition Therapeutics' stock sinks on Phase 2 Alzheimer’s data
New Alzheimer’s data from Cognition Therapeutics appeared to show an early drug effect, but one that lessened over time. Cognition presented Phase 2 results from two dose cohorts comparing its oral...
View ArticleVentyx axes development of TYK2 inhibitor following Phase 2 failure
Ventyx Biosciences is shelving a drug after a mid-stage miss and failure. The company was investigating VTX958, an allosteric TYK2 inhibitor, in patients with moderately to severely active Crohn’s...
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Boehringer Ingelheim buys oncology biotech Nerio Therapeutics for up to $1.3B
Boehringer Ingelheim is paying up to $1.3 billion to acquire a relatively unknown immuno-oncology biotech out of La Jolla, CA. The German drug giant said Monday morning it will buy preclinical-stage...
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