FDA denies Ocaliva full approval, but Intercept hopes to keep drug on market
The FDA rejected the full approval submission for Intercept Pharmaceuticals and Alfasigma’s primary biliary cholangitis treatment Ocaliva after safety concerns dogged the product, casting its future...
View ArticleMerck, AstraZeneca tout Phase 3 win for Koselugo in neurofibromatosis
Merck and AstraZeneca are hoping to expand the label of their MEK inhibitor Koselugo to certain adult patients with neurofibromatosis type 1 following a successful Phase 3 study. The companies
View ArticleSyndax's menin inhibitor succeeds in pivotal trial, but investors aren't...
Syndax Pharmaceuticals said its experimental menin inhibitor met the primary endpoint in a pivotal trial for certain leukemia patients, and it's planning a regulatory filing in the first half of 2025....
View ArticleAstraZeneca CEO reaffirms commitment to China following executive's detention
NEW YORK — AstraZeneca is not backing away from China despite an investigation into its president of China operations. As the company reported its third-quarter earnings, questions continued to swirl...
View ArticlePfizer looking to sell hospital drugs unit — reports
Pfizer is reportedly shopping its hospital drugs unit as it fends off scrutiny from activist investor Starboard Value. The plan was reported Tuesday by Reuters, which said Pfizer had tapped Goldman ...
View ArticleSyros' shares plummet as blood cancer drug fails again
Syros Pharmaceuticals’ stock price nosedived after its last drug candidate flunked a trial in hematological malignancies for the second time in recent months. In a 190-participant Phase 3 trial, the...
View ArticleBioNTech buys out partner Biotheus for PD-L1/VEGF cancer drug
After initially promising more than $1 billion in biobucks to its partner Biotheus for a single drug, BioNTech is now buying out all of the China-based company for $800 million in cash and as much ...
View ArticleExclusive: Flagship names two CEO-partners to lead Valo Health, Apriori Bio
Flagship Pioneering has appointed two new CEO-partners to advise its portfolio companies and help steer its spinouts Apriori Bio and Valo Health, the life sciences incubator and investor told Endpoints...
View ArticleTRexBio raises $84M to take in-house immune program into the clinic
Bay Area immunology biotech TRexBio has raised a $84 million Series B to start clinical studies of a potential treatment for atopic dermatitis and ulcerative colitis. The biotech’s lead candidate,...
View ArticleAfter stock slides, Amgen addresses bone density talk on obesity drug
A lot of Amgen's future rides on its experimental obesity medicine MariTide. At least in the minds of investors. Ahead of the biopharma's most critical readout later this year — a Phase 2 study of the ...
View ArticleOtsuka and ICU Medical forge IV manufacturing network to supply the US
Otsuka Pharmaceutical Factory is paying $200 million to the medical equipment company ICU Medical for an alliance to supply IV products to the US. The joint venture will have a combined capacity of 17...
View ArticleMetsera raises $215M for studies of GLP-1 and amylin obesity drugs
Just seven months after unveiling with $290 million, obesity biotech Metsera is back with another $215 million. The New York-based company will use the Series B funds to support a recently started ...
View ArticlePrimary care unicorn startup Forward Health shuts down
Forward Health, a primary care clinic startup that hoped to make healthcare visits more accessible via "CarePods" in public spaces such as malls, has shut down. Patients got unlimited visits to...
View ArticleAdaptimmune'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...
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