Adaptimmune's second T cell receptor cell therapy for rare sarcomas passes...
Adaptimmune announced Wednesday that its experimental cell therapy based on T cell receptors shrank tumors by at least 30% in nearly half of the patients in a pivotal clinical trial. In 64 patients...
View Article89bio’s $125M offering; Another FDA hold for Kezar
Plus, news about Nippon Shinyaku, Atsena, Orna Therapeutics, Ovid Therapeutics, Graviton Bioscience, Eupraxia, Entero Therapeutics, Journey Therapeutics, Theravance Biopharma, Alpha Cognition and...
View ArticleJ&J takes 340B fight with federal government to court
Johnson & Johnson is suing the federal government over its rebuke of the company’s alternative model for 340B drug price discounts. The company asked a DC federal court on Tuesday to bar...
View ArticleFDA drug inspections have fallen from 2016 peak, GAO says
The US Government Accountability Office published a new report detailing concerns with the staffing of the FDA's drug inspection program, and the fact that the agency continues to conduct "many fewer...
View ArticleDanish biotech Gubra touts early weight loss data in hot amylin field
The amylin field is heating up ahead of Novo Nordisk's much-anticipated CagriSema readout later this year. On Wednesday, Gubra said people taking high doses of its amylin analog, called GUBamy, had ...
View ArticleFDA approves PTC’s ultra-rare disease gene therapy
The FDA has cleared PTC Therapeutics’ gene therapy for AADC deficiency, an ultra-rare disease that impacts the nerve cells and brain. The gene therapy was granted an expansive label encompassing...
View ArticleGSK’s Blenrep combo meets key survival endpoint in Phase 3 multiple myeloma test
GSK continues to stack up wins to support Blenrep’s comeback, as the company teased new survival data from a late-stage multiple myeloma trial on Thursday. In people with second-line or later relapsed...
View ArticleAscidian CEO Michael Ehlers leaves Apple Tree Partners for MPM BioImpact
Ascidian Therapeutics CEO Michael Ehlers is leaving the venture investor that serves as his home base and will join MPM BioImpact as an entrepreneur-partner on Monday, the investment firm told...
View ArticleMerck buys into PD-1/VEGF space as Summit comes for Keytruda
Summit Therapeutics and its Chinese partner Akeso have a few competitors now. Merck, the maker of the drug they're trying to beat, is entering the PD-1/VEGF space by handing down $588 million upfront...
View ArticleMerck KGaA’s life science unit is still feeling the Covid demand decline
A single Covid project that’s not been renewed made an earnings dent in Merck KGaA’s manufacturing arm in the third quarter, but the company is looking to reassure investors that orders are picking up...
View ArticleBeiGene rebrands as BeOne Medicines, dropping name's link to China
The global pharma company whose name rhymes with the capital of China wants people to know that it is not in fact a Chinese company, and is proposing a name change to more emphatically make ...
View ArticleAs bluebird projects more commercial demand, the biotech continues to seek cash
Bluebird bio reported that 17 people with sickle cell disease have started the process of receiving its gene therapy Lyfgenia. Bluebird said in its third-quarter earnings Thursday that it recognized...
View ArticleZai Lab aims to raise $200M; Kronos Bio to seek ‘strategic’ options
Plus, news about Allogene, Telix, Cullgen, Pulmatrix, Gilead, Innocoll, Durect and Sensei: Zai Lab’s $200M offering: The Shanghai-based drugmaker is selling shares the same week as announcing revenue...
View ArticleNovo Nordisk to phase out its production of human insulin pens globally
Novo Nordisk said Thursday that it plans to eventually halt all of its human insulin pen production globally, confirming an Endpoints News report from September. "We do continue to make human insulin ...
View ArticleNew Zealand clears first clinical trial of epigenetic editing for hepatitis B
Tune Therapeutics announced Thursday that New Zealand health authorities are allowing the company to study its experimental epigenetic editing therapy for chronic hepatitis B in humans. It’s the first...
View ArticleLonza expands bioconjugates factory; WuXi Bio adds capacity in Germany
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza said it is expanding a facility in Visp, Switzerland, to house ...
View ArticleEuropean Commission seeks biopharma feedback on Novo-Catalent deal — report
The European Commission is asking biopharma and manufacturing companies about their reaction to Novo Holdings’ proposed acquisition of Catalent, according to Reuters. While the EC declined to comment...
View ArticleLouisiana's Bill Cassidy named next chair of Senate health committee
Sen. Bill Cassidy (R-LA) will take over the Senate Health, Education, Labor, and Pensions Committee when the GOP gets control of the chamber in the next Congress, offering a change of pace on some...
View ArticleArc Institute debuts AI model Evo, makes new CRISPR systems
Less than a decade ago, a slew of startups like Metagenomi and Mammoth Biosciences raised huge sums of money to advance CRISPR gene editing systems found in nature. ...
View ArticleEuropean drug regulator reverses opinion on Eisai and Biogen's Alzheimer's drug
The European Medicines Agency has flipped its stance on Eisai and Biogen’s Alzheimer’s treatment Leqembi, recommending authorization in a narrower population than it previously considered. The agency's...
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