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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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ALX Oncology Holdings Inc. today announced the first patient has been dosed in the Phase 2/3 ASPEN-06 study evaluating the combination of evorpacept, a next generation CD47 blocker, and CYRAMZA ® (ramucirumab).
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Read our takes on the biggest stories happening in the industry.
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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The settlement, announced Wednesday, ends a three-year legal battle allowing Teva Pharmaceuticals to make a generic version of Alkermes’ alcohol and opioid dependence drug Vivitrol.
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases.
Following the FDA’s recent rejection of zuranolone in major depressive disorder, Sage Therapeutics has launched a strategic reorganization initiative including a 40% reduction in headcount.
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
Johnson & Johnson on Wednesday reported multi-billion earnings from its Kenvue consumer health spinout, with updated 2023 revenue guidance down from its previously announced range.
In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.
With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand.
This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.
As the new CEO of LimmaTech Biologics, Haas’ IP and legal background sets him apart to lead the charge for the team’s bacterial vaccine pipeline.
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.