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Biogen CEO sees Alzheimer's drug on right path despite tiny sales, will keep...

A year after unveiling its “Fit for Growth” restructuring effort, Biogen is on track to reverse multiple years of declining revenues, CEO Chris Viehbacher told reporters Thursday. The Cambridge,...

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Sanofi pours €1.3B into new insulin manufacturing plant in Frankfurt

Sanofi is investing €1.3 billion into a new insulin production facility in Germany to help with long-term supply and add power to its European supply chain. The 36,000 square-meter facility will be...

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Arbutus reduces headcount after axing HBV combo trial that features Imfinzi

Arbutus plans to lay off 40% of its staff after ending one of three ongoing midstage hepatitis B trials. The decision to cut the study — testing lead asset imdusiran plus a nucleos(t)ide analogue in...

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Blueprint ups Ayvakit guidance; Aurinia to advance autoimmune disease asset

Plus, news about Novo Holdings, Oxford Nanopore, Ionis, Valneva, LimmaTech and Bayer: Blueprint pulls in $114.1 million for Ayvakit: The company raised its net product revenue guidance to between $435...

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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...

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Novartis 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...

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Despite 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...

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Adaptimmune 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...

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Agios' 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...

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Galapagos 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...

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PARP 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...

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23andMe 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...

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Kyowa 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...

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Apogee 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...

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