BridgeBio spotlights 12 and 18-month data for potential achondroplasia drug...
BridgeBio touted longer-term data for its achondroplasia drug infigratinib from a mid-stage trial on Tuesday, setting the treatment up to be a future competitor for BioMarin’s Voxzogo, the first and...
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Bristol Myers' Opdivo-Yervoy combo hits endpoints in Phase 3 early liver...
Bristol Myers Squibb’s Opdivo and Yervoy combo could become the new standard of care in first-line unresectable hepatocellular carcinoma (uHCC) according to Phase 3 data presented at the American...
View ArticleNovo Holdings’ head of Asia on investing in ‘China for China,’ and staying...
Geopolitical headwinds may have given some foreign life sciences investors pause about investing in China. But for Novo Holdings Asia, it’s a good time to double down. The group is finding valuations...
View ArticleWhat the first four participants for FDA's Operation Warp Speed for rare...
FDA’s biologics chief Peter Marks famously coined the first race to the Covid-19 vaccine as Operation Warp Speed. Now the second iteration of OWS is targeting rare diseases, with the FDA officially...
View ArticleVilya raises $21M in Series A extension; Shionogi to build research center in...
Plus, news about Immutep, Eisai and Iterum Therapeutics: Computational biotech extends Series A: Vilya Therapeutics, a startup based in Seattle, added $21 million to its Series A, which it first...
View ArticleViking expands on Phase 2b data for NASH drug, touting histological endpoints
Viking Therapeutics announced Tuesday morning new data from a Phase 2b trial looking at its NASH drug, aiming to provide a fuller picture of the results before beginning a pivotal study. The biotech...
View ArticleUK's NICE recommends Lilly's Zepbound for weight loss
The UK’s National Institute for Health and Care Excellence (NICE), which advises the National Health Service on which drugs to cover, released new draft guidance on Tuesday recommending the use of Eli...
View ArticleHouse lawmakers float transparency reforms for 340B program at hearing
WASHINGTON – House lawmakers on Tuesday floated reforms to a controversial drug discount program serving low-income populations, but it’s still unclear which policies will come to fruition and how. The...
View ArticleLykos’ MDMA-assisted therapy stumbles at adcomm amid questions about study,...
An FDA advisory committee voted against backing Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder, a blow to the biotech company’s efforts to bring the first ecstasy-based...
View Article#EASL24: Vir's early Phase 2 hepatitis D data show reduction, removal of...
Vir’s chronic hepatitis D treatment reduced the presence of the virus RNA as well as normalized certain liver enzyme levels across 24 weeks in a mid-stage test. In the Phase 2 SOLSTICE study, some...
View Article#EASL24: Lilly details mid-stage win for tirzepatide in MASH with fibrosis data
Eli Lilly has unveiled fibrosis results from a Phase 2 test of tirzepatide in patients with metabolic dysfunction-associated steatohepatitis, or MASH, which could help further increase the blockbuster...
View ArticleBioNTech co-founder Özlem Türeci on ‘hip’ ADCs and the power of combo therapies
CHICAGO — Özlem Türeci took a seven-year break from attending the American Society of Clinical Oncology’s annual meeting. She’d been busy with the Covid-19 pandemic as co-founder and chief medical...
View ArticleRadiopharmaceutical company Telix aims for $202M IPO
Amid booming interest in radiopharmaceuticals, Telix Pharmaceuticals is planning to become a publicly traded company in the US. The biotech, based in North Melbourne, Australia, on Wednesday disclosed...
View ArticleCytokinetics CEO addresses acquisition rumors, says buyer walked away, SEC...
Cytokinetics CEO Robert Blum disclosed publicly for the first time rumors of a potential buyout that fell through late last year, according to a new securities filing. The rumors first arose during the...
View ArticleRayzeBio warned of potential isotope supply issues before BMS deal
RayzeBio advised investors last year it could face problems securing actinium isotope from a Russian supplier that it relies on for international studies. Bristol Myers Squibb announced plans in...
View ArticleArriVent inks ADC deal with Alphamab; Annexon's $125M offering
Plus, news about Equillium and Structure Therapeutics: ArriVent, Alphamab team up on multi-ADC collab: The companies will work together to develop multiple antibody-drug conjugates using Alphamab’s...
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AI is unlikely to take off among CDMOs at the same scale as biopharma...
With AI drumming up interest in drug discovery and R&D, Endpoints News asked insiders how CDMOs are thinking about using AI tools in manufacturing. Their response? AI uptake is stymied by tough...
View ArticleFDA hands Chinese drug manufacturer a Form 483 noting employees destroyed...
Employees of Chinese drugmaker Jiangsu Hengrui Pharmaceuticals “diverted” FDA inspectors as colleagues tore up and threw away documents in a “rapid-like manner” at a manufacturing facility, according...
View ArticleOregon jury says J&J owes talc claimant $260M
An Oregon jury awarded a talc claimant $260 million in a verdict against Johnson & Johnson on Monday. The case was brought by a 49-year-old mother of three named Kyung Lee, who claimed J&J’s...
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Amgen's Uplizna succeeds in Phase 3 trial for rare autoimmune disease
Amgen released new Phase 3 data Wednesday for its rare disease drug Uplizna in an autoimmune condition, bringing it potentially closer to another FDA approval. The results may put additional pressure...
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