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Exclusive: Flagship-backed Valo Health loses interim CEO ahead of key Phase 2...
Valo Health, the well-funded computational drug discovery and development startup launched by Flagship Pioneering, lost its interim CEO less than a year after he took the role, Endpoints News has...
View Article4DMT's gene therapy reduced need for standard-of-care injections to treat...
4D Molecular Therapeutics’ one-time gene therapy reduced the need for annual injections in patients with age-related blindness in a mid-stage trial. The company on Wednesday reported updated Phase 1/2...
View ArticleAscendis aims to raise $300M; Basilea inks up to $268M deal with BARDA
Plus, news about GSK, Novo Nordisk, Tanai Therapeutics, Nomic Bio, Brenus Pharma, Xspray, Achilles Therapeutics, BioXcel Therapeutics and Nuvalent: Ascendis’ $300M offering: The Danish company...
View ArticleEdgewise’s stock surges as heart drug passes early safety test
Edgewise Therapeutics has unveiled early safety data for its rare heart disease drug, with results suggesting it could do away with a black box warning seen with Bristol Myers Squibb’s Camzyos in...
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Fertility benefits giant Progyny loses client that accounted for 13% of its...
Progyny lost a big client that made up around 670,000 members, the fertility benefits company said in a securities filing Wednesday, though analysts remain optimistic about the space. The unnamed...
View ArticleBioCentriq names ex-Resilient exec as new CEO; Sanofi, AstraZeneca boost...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Cell therapy CDMO BioCentriq has appointed Syed Husain as its new...
View ArticleFDA inspectors discover trucks carrying torn-up records leaving Indian...
Generic drug maker Granules India has been criticized by the FDA after inspectors found three trucks full of torn-up manufacturing documents and bird droppings at one of its factories. On the first...
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Lasker Award goes to three scientists who pioneered research behind GLP-1 drugs
Three scientists whose work paved the way to the multibillion-dollar obesity drug boom have won the Lasker Award for “the discovery and development of GLP-1-based drugs that have revolutionized the...
View ArticleHouse committee advances PRV reauthorization, but timing on final passage...
The House Energy & Commerce Committee unanimously advanced a bill late Wednesday that would reauthorize the rare pediatric priority review voucher (PRV) program through 2029. But the House bill and...
View ArticleAligos’ trial for oral MASH treatment succeeds, but placebo group shows odd...
Aligos Therapeutics’ oral treatment for an advanced form of fatty liver disease reported positive results in a Phase 2 trial, showing it was effective at reducing fat across three dose levels. Despite...
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Sanofi's BTK inhibitor again slows MS progression, but liver enzymes continue...
Sanofi released new Phase 3 data for its BTK inhibitor tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS), showing a 31% improvement in delaying onset of disease...
View ArticleGilead's Kite uncouples from Fosun in China as Yescarta faces coverage obstacles
Gilead’s Kite Pharma is separating from its cell therapy joint venture with Fosun Pharma in China, handing Fosun the reins for its CAR-T therapy Yescarta in the region. Other foreign drugmakers have...
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Lexicon's president to step down as decision date looms; Sarepta welcomes...
Jeff Wade → The top leadership at Lexicon Pharmaceuticals is still undergoing a major makeover as president and COO Jeff Wade heads for the exit on Sept. 30 after 25 years with the Texas-based biotech....
View ArticleNovo axes Phase 2 of Forma-acquired drug in myelodysplastic syndromes
Novo Nordisk has ended one of the multiple trials testing the lead oral drug from its $1.1 billion Forma Therapeutics buyout, according to an update to the US federal trials database this week. The...
View ArticleJ&J subsidiary files for third bankruptcy to settle talc claims
A Johnson & Johnson subsidiary filed for bankruptcy in its third attempt to settle a vast majority of cases alleging its talc products caused cancer. The $8 billion settlement plan would resolve...
View ArticleA small startup is challenging Epic's control over patient health records
A software startup has sued Epic on antitrust grounds, arguing that the electronic health records giant has orchestrated a scheme to destroy the startup’s business and maintain its monopoly over...
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Biogen, UCB declare Phase 3 lupus win and prep a second trial, but details...
Biogen and UCB said Tuesday morning that data from a Phase 3 study for the lupus program dapirolizumab pegol were strong enough to convince it to launch a second pivotal trial to confirm the benefit...
View ArticleFlagship’s AI biotech Generate lands $65M upfront in Novartis deal, as first...
The AI-focused biotech Generate:Biomedicines announced another pharma partnership Tuesday, agreeing to work on several protein therapies with the Swiss drugmaking giant Novartis. Novartis will pay $50...
View ArticleConstructive Bio raises $58M for synbio work, and Nobel laureate joins board
A UK-based synthetic biology startup has brought in $58 million from private investors to fund its work engineering cell systems that can manufacture new and existing molecules. The company, called...
View ArticleClive Meanwell's new obesity biotech, Metsera, unveils early GLP-1 data with...
Metsera, the well-funded obesity biotech from Population Health Partners and ARCH Venture Partners, has unveiled its first clinical data just a few months after emerging with $290 million and a broad...
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