Pfizer mulls facility sale; GSK penalized in South Korea for administrative...
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Pfizer is considering selling a facility it bought from Abzena in...
View ArticleNovartis sues FDA over approval of Entresto generic, following rejection of...
Novartis is going after the FDA over the agency’s decision to approve a generic version of the cardiovascular drug Entresto earlier this year. The Swiss drugmaker sued the government after the FDA in...
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RSV market pressure leads to slower launch for Moderna's vaccine
The RSV market is turning out to be tougher than Moderna hoped. Jamey Mock The company’s mResvia is the third RSV vaccine to enter a market dominated by GSK’s Arexvy and Pfizer’s Abrysvo. That pressure...
View ArticleDespite recent trial success, uniQure plans to cut 65% of staff
Less than a month after promising data sent uniQure’s shares soaring, the company is disclosing significant layoffs to 65% of the company. The new wave of cuts disclosed in the biotech’s second-quarter...
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GSK scores expanded label for Jemperli in first-line endometrial cancer
GSK’s Jemperli can now be used as a first-line treatment for all adult endometrial cancer patients following an expanded label approval in the US. The FDA approved the PD-1 antibody in combination with...
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Vir's overhaul brings an end to most virology work — and a beginning with cancer
Last year’s layoffs were just the start for Vir Biotechnology. The company is now shifting the direction of its clinical and corporate operations by prioritizing clinical-stage hepatitis B and D...
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Vertex says about 20 patients have started sickle cell therapy, cuts two rare...
Vertex Pharmaceuticals is picking up momentum in its strategy of branching out beyond cystic fibrosis. About 20 patients have had their cells collected for Casgevy, Vertex’s sickle cell gene therapy...
View ArticleAdaptimmune gets FDA accelerated approval for T cell receptor cell therapy in...
The FDA granted accelerated approval to a cell therapy for synovial sarcoma, a rare type of cancer typically found in the tissue of the arms and legs. Developed by Adaptimmune Therapeutics, it’s the...
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Exclusive: Ultragenyx secures first funds for Alzheimer's gene therapy spinout
Rare disease specialist Ultragenyx reeled in a $14 million seed round for its Alzheimer’s gene therapy spinout Amlogenyx, the company exclusively told Endpoints News. The California biotech’s...
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Former RayzeBio CEO quickly returns with new biotech; Amgen’s global research...
Ken Song Ken Song is back in business. He left RayzeBio in February after leading the radiopharmaceuticals startup from Series A to IPO in three years, and then a $4.1 billion exit to Bristol Myers...
View ArticleAgios' late-stage Pyrukynd trial in kids with rare blood disorder misses...
Agios’ first-ever pediatric data readout missed the primary endpoint, with its drug Pyrukynd (mitapivat) not showing statistical significance in children with pyruvate kinase (PK) deficiency who are...
View ArticleGalapagos pauses blood cancer CAR-T therapy trial due to one Parkinsonism event
Galapagos has temporarily stopped enrolling patients into an early-phase test in patients with multiple myeloma after a neurological issue was raised. Elsewhere, the biotech expanded its deal with...
View ArticlePARP biotech backed by more than five pharmas closes after nine years
Ribon Therapeutics has shuttered after nine years, and one year after ending its preclinical research to focus on two early-stage PARP programs in cancer and atopic dermatitis. The Cambridge, MA-based...
View Article23andMe board rejects Anne Wojcicki’s take-private plan, requests changes
CEO Anne Wojcicki’s offer to take her genetic testing company 23andMe private for 40 cents a share has been met with resistance from her own board. In a letter sent Friday, a special committee of board...
View ArticleKyowa Kirin divests China unit, prunes discovery and manufacturing work
Kyowa Kirin is selling off its China business and transitioning to a research organization in a shake-up that could lead to major cuts to the company’s in-house discovery and CMC work. The Japanese...
View ArticleApogee and Spyre founder launches another autoimmune biotech, and it's got...
Amid an action-packed Thursday, another biotech launched to take on the ever-popular landscape of autoimmune drug development. And the new Boston-area biotech comes from a repeat creator: Paragon...
View ArticleIn Japan, sales of Eisai and Biogen's Alzheimer's drug begin to accelerate
Biogen and Eisai’s Alzheimer’s drug Leqembi is off to a slow start in the US. But it’s big in Japan. On Friday, Eisai revealed in an investor presentation that Japanese revenue accounted for 1.5...
View ArticleExclusive: Devoted Health raises $112M, plots insurance markets expansion
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Devoted Health just nabbed another $112 million in venture funding to fuel its push into seven new...
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Iron chelator therapy unexpectedly worsened Alzheimer’s disease in clinical...
PHILADELPHIA — Among the many mysteries of Alzheimer’s disease is the role that iron plays. The metal is vital for transporting oxygen in the blood and producing energy from mitochondria, but some...
View ArticleMassachusetts' plan for $1B in life science investment stalls in state...
Massachusetts Gov. Maura Healey’s proposal to invest another $1 billion in life sciences over the next 10 years has been imperiled after failing to make it through the state’s legislative body before...
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