EMA reviews hair loss products following concerns about suicidal thoughts
The European Medicines Agency is looking more closely at medicines used to treat hair loss and a condition caused by an enlarged prostate over concerns about suicidal thoughts. The review encompasses...
View ArticleBARDA doles out $72M to Sanofi, GSK and CSL for bird flu vaccine supply
The Center for Biomedical Advanced Research and Development Authority (BARDA) is giving $72 million to three drugmakers to help fortify the US supply of bird flu vaccine ahead of 2025. The funding was...
View ArticleWuXi companies consider sale of units impacted by Biosecure; J&J, Bayer trim...
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View ArticleMany drug price proposals from candidates and Congress won't have much...
Want to lower drug prices? Good luck. In a new report released Friday, the nonpartisan Congressional Budget Office (CBO) detailed how many of the campaign proposals mentioned by presidential nominees...
View ArticleNovo and Viatris settle Ozempic patent suit as generic entry date remains...
Novo Nordisk and Mylan Pharmaceuticals, now part of Viatris, have settled their patent dispute over Novo’s blockbuster diabetes drug Ozempic. The Danish company declined to comment on the terms of its...
View ArticleJ&J’s ‘pretzel’ drug-device therapy fails Phase 3 in certain bladder cancer...
Johnson & Johnson’s drug-device combo has disappointed in a late-stage test in people with an advanced form of bladder cancer, but it says it is still confident in the technology’s overall...
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Exclusive: Tiny startup with big vision to extend healthspan by 20 years says...
Last August, stem cell biologist and bit.bio founder Mark Kotter launched a new startup with an ambitious goal: within a year, to identify every gene that plays a role in restoring or repairing aging...
View ArticleMerck partners with small UK biotech to drug fibroblasts for fibrosis, I&I...
As Merck builds out its immunology research lab in London, it’s partnering with a local biotech startup that has remained relatively quiet since its seed round in 2021. The pharma giant said Tuesday...
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Astellas places new bet on gene therapy in $50M upfront deal with London's...
As it works to rebuild from an earlier gene therapy setback, Astellas is doubling down on the one-and-done modality in a new deal with a London-based startup already in the clinic. Astellas said...
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Sage faces third Phase 2 fail in six months as dalzanemdor misses goal in...
Sage Therapeutics is reeling from another mid-stage setback as its investigational medicine dalzanemdor has missed the mark in a Phase 2 mild cognitive impairment trial. The drug, an NMDA receptor...
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Exclusive: Lilly backs a16z-funded Arda Therapeutics' $43M Series A to take...
A three-year-old startup based on decades of research in cell depletion is betting that some of the hottest tools in oncology may work even better in other diseases. Arda Therapeutics has raised a $43...
View ArticleOrasis snags $78M to launch presbyopia eye drops more than a year after FDA...
Last October was an FDA approval. This October is a $68 million fundraising round. Next year, maybe a drug launch. Orasis Pharmaceuticals announced a Series D round on Tuesday, plus another $10 million...
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Biogen to seek approval for high-dose Spinraza after unveiling new data
Nearly eight years after securing a historic first approval for a spinal muscular atrophy drug, Biogen is seeking to launch a new dosing regimen of Spinraza. Clinical trial data unveiled on Tuesday...
View ArticleScholar Rock aims to raise $275M; Vincerx to reshuffle pipeline focus
Plus, news about Vicore: Scholar Rock seeks $275M in stock sale: After announcing the success of a pivotal clinical trial for its muscle-targeted spinal muscular atrophy treatment, Scholar Rock’s...
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Black Diamond cuts workforce, prioritizes lung cancer drug
Black Diamond Therapeutics is cutting an unspecified number of workers, including several executives, and making changes to its pipeline in an effort to extend its cash runway. Fang Ni As part of the...
View ArticlePfizer's former top executives pitched changes to board as part of activist's...
Pfizer’s former CEO and CFO relayed proposals from activist investor Starboard Value to several members of the company’s board on Sunday, according to a source familiar with the conversations, as part...
View ArticleExclusive: A small San Diego biotech wants to change how Parkinson’s disease...
A protein called alpha-synuclein that accumulates and ravages the brains of some people with Parkinson’s disease is the target of several experimental drugs. Until recently, the only way to detect it...
View ArticleJohn Maraganore's RNAi biotech City Therapeutics debuts with $135M Series A
City Therapeutics has launched with $135 million and Alnylam’s former CEO leading the charge as it develops a pipeline of next-generation RNAi therapies that could act on tissues apart from the liver,...
View ArticleCompounding pharmacy group sues FDA for ending Eli Lilly's GLP-1 drug shortage
A trade group for large compounding pharmacies sued the FDA over its move to take Eli Lilly’s blockbuster GLP-1 drug off its shortage list, hamstringing compounders’ ability to create their own,...
View ArticleJim Wilson secures $100M for global approach aimed at reviving gene therapy...
A gene therapy pioneer thinks he has a solution to the field’s struggle to commercialize breakthrough cures: Go global. Jim Wilson’s Philadelphia-based company GemmaBio on Tuesday announced up to $100...
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