4DMT'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...
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Novo says its CB1 drug helped shed weight, but efficacy and safety questions...
Novo Nordisk’s $1 billion bet last year on a small Canadian biotech could expand the Danish drug giant’s arsenal of obesity medicines, but it will first have to address safety concerns. On Friday, Novo...
View ArticleBiotech VC firm outlines plans for $100M fund
An early-stage biotech investor called YK Bioventures plans to raise $100 million, according to an SEC filing on Wednesday. The VC firm has invested in at least five startups, according to public...
View ArticleFDA approves Zevra’s rare disease drug after resubmission
After a second review, the FDA approved Zevra Therapeutics’ treatment for Niemann-Pick disease type C, a progressive rare genetic disease caused by the accumulation of certain fatty substances....
View ArticleYuhan ends cancer project with J&J as it signs API deal with Gilead on HIV...
Yuhan and Johnson & Johnson Innovative Medicine (JJIM), formerly known as Janssen, ended a research project after securing approval in the US for a similar drug. The South Korean pharma company...
View ArticleFTC to sue major PBMs over insulin rebates, claiming they inflated patient cost
The Federal Trade Commission said that it is suing the three major US pharmacy benefit managers over their role in the insulin market, claiming that the companies’ practice of using large rebates has...
View ArticleEuropean regulators reaffirm Apellis’ rejection, add 8 positive recommendations
Apellis has had its European ambitions dashed once again after regulators reaffirmed their decision to not recommend the company’s treatment for geographic atrophy due to age-associated blindness. The...
View ArticleFDA OKs the first-ever self-administered vaccine, for flu
Americans can now vaccinate themselves against the flu without the assistance of a healthcare worker. For the first time, the FDA approved a vaccine that people can administer themselves, clearing the...
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