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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
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Allogene Therapeutics, Inc. today announced the appointment of Susan Lundeen as Chief People Officer effective May 2, 2022.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.
The company’s immunotherapy, in combination with chemotherapy Avastin, showed favorable progression-free survival in a late-stage hepatocellular carcinoma study.
Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.
The two mid-stage flops—one in major depressive disorder and another in focal onset seizures—involve drug candidates from partnerships with Xenon Pharmaceuticals and Takeda, respectively.
The biopharma’s Adzynma, a human recombinant ADAMST13 therapeutic, is the first approved therapy for the ultra-rare clotting disorder congenital thrombotic thrombocytopenic purpura.
Over the next two weeks, the FDA is set to decide on New Drug Applications from Pacira, CorMedix and Aldeyra and hold an advisory committee meeting for two overdue confirmatory trials from Acrotech.
The Federal Trade Commission is challenging over 100 pharmaceutical patents held by prominent drugmakers, including AbbVie, AstraZeneca and Boehringer Ingelheim, for their listings.
As Vertex and CRISPR Therapeutics await the monumental potential approval of exa-cel, bluebird bio, Iovance and Rocket Pharmaceuticals wait patiently in the wings.
While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings.
The vaccine maker is prepared to cut another $300 million in operating expenses in 2024 to keep the company afloat as it works to get its combination COVID-19/flu vaccine into Phase III.