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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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Thermo Fisher Scientific Inc., the world leader in serving science, today introduced the Thermo Scientific Centrios HX Circuit Edit System.
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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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Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
The Supreme Court of the United States has granted the Department of Justice’s motion for a stay regarding Purdue’s bankruptcy case and is set to assess the legality of the settlement in December.
At AAIC, researchers presented studies using CRISPR-Cas9 in animal/organoid models of Alzheimer’s disease, but some experts doubt that such approaches will successfully translate to humans.
The Securities and Exchange Commission has joined the mounting antitrust scrutiny of Illumina’s acquisition of the cancer diagnostics company, according to an SEC filing by the DNA sequencing giant.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
Amid record sales of its obesity treatment Wegovy, as well as diabetes drugs Ozempic and Rybelsus, Novo is buying Canadian biotech Inversago Pharma to further boost its weight-loss pipeline.
Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
The company has lowered its 2023 guidance amid leadership changes and antitrust scrutiny. Illumina now expects a 1% increase in revenue, down from its previous 7% to 10% growth forecast.
After the regulator rejected avasopasem manganese, its candidate for severe oral mucositis, Galera is implementing a restructuring initiative that involves reducing its headcount by 70%.
With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.