Nkarta to lay off 34% of staff; Savara’s debt financing deal
Plus, news about Bicycle Therapeutics, Kelso Pharma, Arbutus Biopharma, Ascletis Pharma, Alvotech and Xbrane: Nkarta axes 34% of staff: The cell therapy maker said the layoffs of 53 workers would help ...
View ArticleWhat happened to Miga Health
My latest story is one I don’t get the chance to write often — maybe ever. When I first heard some murmurs that Miga Health, a virtual cardiovascular care company, had stopped taking patients, I...
View ArticleEquillium says graft-versus-host drug fails Phase 3, stock dives
A penny stock biotech reported that its acute graft-versus-host disease drug failed a late-stage trial, but it still plans to seek accelerated approval. Equillium said Thursday that itolizumab did not...
View ArticleChiesi pours €430 into new Italy site; Bharat’s first CGT site in India
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Chiesi is investing €430 million ($358 million) over the next five...
View ArticleNew pharma tariffs could put generic drugmakers under pressure
President Donald Trump’s threatened tariffs on pharmaceuticals are incentivizing drugmakers to build more manufacturing capacity in the US. But makers of generics likely won’t have the resources to...
View ArticleExclusive: Metsera CEO on what it takes to build an obesity biotech in 2025
Metsera, one of the few biotechs to complete an IPO this year, is making its best effort to catch up to the obesity drug giants: Eli Lilly and Novo Nordisk. The startup landed a ...
View ArticleMerck details injectable Keytruda data as it awaits FDA decision
Merck shared Phase 3 data showing that an injectable version of its blockbuster cancer drug Keytruda is comparable to the approved intravenous infusion in lung cancer patients. And it said it' ...
View ArticleFDA’s policy, communications staff likely to be among agency’s 3,500 staff cuts
HHS’ plans to eliminate almost 20% of the FDA’s staff will likely take a major toll on policy, communications and other administrative staff at the agency, according to agency veterans and other...
View ArticleMerck KGaA pays Abbisko $85M for full commercial rights to benign tumor drug
Merck KGaA is spending $85 million to tap global commercialization rights to pimicotinib, a candidate for non-malignant tumors that it licensed from China’s Abbisko Therapeutics in 2023. The German...
View ArticleBefore Alumis went public via IPO, it tried doing a reverse merger with Acelyrin
Last month's all-stock merger proposal between Alumis and Acelyrin wasn't the first time the companies considered a deal. A Thursday SEC filing reveals how, almost a year ago, Alumis approached...
View ArticleOn the heels of staff cuts, CRISPR Therapeutics COO departs; Changes galore...
→ After a 6-year run, CRISPR Therapeutics COO Julianne Bruno is stepping out the door to pursue other opportunities. Bruno's departure comes nearly a month after the gene editing company ...
View ArticleNovo makes oral obesity drug partnership with Lexicon worth up to $1B
Novo Nordisk is going all-in on next-generation obesity medicines, and on Friday announced a licensing deal with a Texas biotech to get access to its oral small molecule drug. Under the deal, Lexicon...
View ArticleBioNTech details promising mid-stage data for its PD-L1xVEGF in aggressive...
BioNTech has highly encouraging survival data for its bispecific antibody combining checkpoint blockade with VEGF-A inhibition as a first-line treatment for a serious form of lung cancer. And if the...
View ArticleEuropean regulator rejects Lilly's Alzheimer’s drug over side effects
Eli Lilly’s Alzheimer’s drug Kisunla has failed to get support from the European Medicines Agency over serious side effects and three patient deaths. The agency’s human medicines committee (CHMP)...
View ArticleDBV’s financing for peanut allergy patch; Eisai divests proton pump inhibitor...
Plus, news about Palatin, Spero and BioAtla: DBV Technologies’ $306M financing: The French biotech could get up to that amount to help advance its peanut allergy patch for children through an ...
View ArticleMilestone's shares dive after FDA again rejects drug for abnormal heart rhythm
Milestone Pharmaceuticals’ nasal spray failed for a second time to secure US approval to treat an arrhythmia disorder called paroxysmal supraventricular tachycardia. The FDA’s complete response letter...
View ArticleCHMP acts on Opdivo, Tevimbra, Xoanacyl, Kisunla and others
Bristol Myers Squibb, BeiGene, AstraZeneca and Pfizer secured European backing for label expansions, and a French pharma got its first drug approval recommendation, in a list of actions by the European...
View ArticleJ&J wins patent feud against Viatris over schizophrenia drug
Johnson & Johnson scored an appeals court win in its bid to block generic competition for its long-acting schizophrenia drug. The US Court of Appeals for the Federal Circuit on Friday
View ArticleFDA approves Sanofi's RNAi drug for hemophilia A and B
The FDA on Friday said it approved a new RNAi-based hemophilia treatment from Sanofi that the company licensed from Alnylam. Patients with hemophilia A or B will now be able to ...
View ArticleNovartis’ radiopharma drug Pluvicto gets an expanded label
Novartis’ prostate cancer radiopharmaceutical Pluvicto has netted a highly anticipated and highly delayed expanded indication. The FDA on Friday approved the drug for certain patients before they have...
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