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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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Biogen Inc. (Nasdaq: BIIB) today announced that, effective January 1, 2022, it will reduce the wholesale acquisition cost (WAC) of ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in the United States by approximately 50%. For a patient of average weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg) will be $28,200.
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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.
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The company will present data at the oncology meeting showing the drug’s significant survival benefit in patients with advanced renal cancer and recurrent, persistent and metastatic cervical cancer.
The Massachusetts-based biopharma became the second company this week to drop its amyotrophic lateral sclerosis hopeful after it failed to elicit significant improvement compared with placebo.
Although still in early-stage testing, Ensysce Biosciences’ formulation has demonstrated the potential to address addiction problems associated with oral oxycodone.
The AI drug discovery company’s reorganization will include laying off around 180 employees and dropping its atopic dermatitis candidate BEN-2293 in an effort to save nearly $56 million.
The investigational kinase inhibitor failed to improve overall survival in the SAPPHIRE study of patients with non-squamous non-small cell lung cancer, causing Mirati to discontinue its development.
The company’s candidate, ANX007, did not significantly slow lesion growth in a Phase II trial but was effective at preserving visual function in patients with a form of dry age-related macular degeneration.
The FDA approved Braeburn Pharmaceuticals’ new buprenorphine treatment option with extended-release medication that could pave the way for greater patient compliance.
Autistic employees bring a uniquely valuable skill set to the life sciences workplace, but it’s on the employers to provide the support they need.
Wave will discontinue development of WVE-004 in C9-associated ALS and frontotemporal dementia after the therapy failed to show any clinical benefit in a mid-stage trial.
The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.