CBER head Prasad adds chief medical and scientific officer to his title
Vinay Prasad, the newly-minted chief of the FDA's biologics center, will now have two additional roles as chief medical and scientific officer, FDA Commissioner Marty Makary told staff in a Wednesday...
View ArticleZealand study shows higher GLP-1/GLP-2 doses may lead to greater weight loss
Zealand Pharma on Wednesday rolled out more Phase 1b data for its experimental GLP-1/GLP-2 drug, showing that higher doses could lead to more weight loss in people who are overweight or obese. The...
View ArticleCompounders lose case over semaglutide shortage
A federal court once again ruled against a trade group for large compounding pharmacies that sought to put Novo Nordisk’s blockbuster obesity drug semaglutide back on the FDA’s shortage list so...
View ArticleGilead gets groundbreaking FDA approval for twice-yearly HIV prevention shot
The FDA has approved Gilead Sciences’ lenacapavir for HIV prevention, making the highly-anticipated twice-yearly shot available to people in the US. Lenacapavir was approved for pre-exposure...
View ArticleGrail shares jump on study results for cancer test
Grail's shares jumped on Wednesday after the company reported what it called encouraging results in its cancer detection test. The company, which aims for early detection of multiple cancers in a blood...
View ArticleFDA's top cell and gene therapy leaders leave agency
The FDA's top leadership in its cell and gene therapy division have been let go, sources told Endpoints News, in the latest shakeup at the agency that has seen significant numbers of staff and other ...
View ArticleRoche's venture arm chief to step down in 2026; AstraZeneca obesity leader...
→ Carole Nuechterlein said on LinkedIn that she is retiring as head of the Roche Venture Fund “next spring.” Nuechterlein has held this position since 2001. Roche’s venture arm recently participated in...
View ArticleEnzene, Veranova separately unveil expansions; Lotte's new ADC client
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Enzene announced it plans to expand its biologics production facility...
View ArticleFDA OKs new label expansions for Dupixent and Incyte's Monjuvi
Plus, news about Novartis' Mariana Oncology: FDA approves Dupixent in rare autoimmune disease: The approval is for bullous pemphigoid, a condition in which the immune system attacks ...
View ArticleEarly-stage investor Syncona readjusts priorities due to bleak biotech market
The desolate biotech financing environment is starting to take a toll on investment funds, with the UK life sciences firm Syncona announcing it is realigning its priorities. Syncona will look for ways...
View ArticleUK's NICE says Alzheimer's drugs aren't worth national coverage
Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla should not be covered under the UK's national health insurance because the Alzheimer's drugs' benefits don't outweigh their high cost, the country's...
View ArticlePharma companies are weighing how a drug’s IP location could impact tariffs
Over the past few months, several biopharma companies like GSK, Merck, Alnylam and BioMarin have said they are monitoring how the location of their drugs’ intellectual property could be relevant to...
View ArticleFDA to biotech CEOs: US is lagging behind on early-stage trials
Top FDA officials sided with biotech CEOs this week on the need to speed up drug reviews to stay competitive with China and other countries, in the latest agency "listening" session with industry....
View ArticleCHMP recommends five new drugs, reconsiders Eli Lilly’s Kisunla
The European Medicines Agency’s human medicines committee (CHMP) recommended the authorization of five new medicines this week and announced that it has begun its reexamination of Eli Lilly’s...
View Article#ADA25: Vertex's diabetes cell therapy allows 10 patients to come off insulin
Vertex Pharmaceuticals’ cell therapy for type 1 diabetes allowed 10 of 12 patients (83%) to stop taking insulin a year after they were infused, according to results presented Friday. The data came from...
View ArticleFDA unveils new pilot program; Sage finds a buyer; Eli Lilly to acquire...
Welcome back to another edition of Endpoints Weekly, and happy start to the summer! The North Pole reached its maximum tilt toward the sun at 2:42 a.m. UTC this morning (10:42 p.m. Friday night on ...
View ArticleA puzzling update from Novo Nordisk and new data from Roche at #ADA25
The annual meeting of the American Diabetes Association is underway in Chicago. The confab has already yielded a major update from Vertex Pharmaceuticals and more exciting data are on the way. But ...
View ArticleCompass reports Phase 3 depression data for psilocybin drug
Compass Pathways said Monday its psilocybin drug has cleared the first of two late-stage tests in a challenging form of depression as it advances toward the potential of becoming the first classical...
View ArticleIllumina to buy SomaLogic for $350M upfront, pushing further into proteomics
Illumina has agreed to pay $350 million upfront for SomaLogic, the companies announced on Monday, in a deal that underscores the DNA giant's strategy of offering a broader look at biology. SomaLogic...
View Article#ADA25: Lilly’s bimagrumab boosts weight and fat loss when added to Novo's...
Eli Lilly’s muscle-boosting drug allowed obese patients who are taking Novo Nordisk’s Wegovy to retain almost all of their lean tissue, according to data presented Monday. The data are from a Phase 2b...
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