FDA 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 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...
View ArticleHouse passes reauthorization of rare pediatric voucher program
The US House of Representatives on Monday afternoon unanimously passed a wide-ranging bill via voice vote that will reauthorize the rare pediatric priority review voucher program through 2029, among...
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Updated: Gene therapy maker bluebird bio cuts costs again, lays off staff
Bluebird bio is cutting more jobs and expenses in the latest bid to manage its fragile finances as it supports the launch of its sickle cell gene therapy Lyfgenia. The company announced earlier Tuesday...
View ArticleHealth plan startup Centivo raises $75M
Centivo, a startup that sells health insurance to employers, raised $75 million in fresh funds months after it bought a virtual primary care startup to use in its offerings. The startup’s goal is to...
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