Patients treated with Aduhelm experienced decreased levels of tau — the second dysregulated protein in Alzheimer’s disease — which were associated with a slowing of cognitive decline, Biogen executive Samantha…
The FDA has issued a Form 483 to Advanced Accelerator Applications, citing quality and laboratory control issues observed during an inspection of the company’s sterile drug manufacturing facility in Millburn,…
Four rival drugmakers have joined forces to help develop digital clinical measures to assess whether new treatments for Alzheimer’s disease and related dementias are working. Source: Drug Industry Daily
Merck is stopping a phase 3 trial of its mega blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s blockbuster PARP inhibitor Lynparza (olaparib) for prostate cancer after an independent…
The FDA has posted draft guidance for sponsors developing CAR-T cell products. Source: Drug Industry Daily
The FDA has advised sponsors of gene therapy products that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft…
The European Medicines Agency (EMA) is seeking comments from the public on a draft pharmacovigilance guideline published yesterday on assessing the risk of drug-related fetal abnormalities and when to employ…
The FDA has released its over-the-counter (OTC) monograph drug user fees for fiscal 2022. Source: Drug Industry Daily
The FDA has sent AstraZeneca a Complete Response Letter (CRL) over its supplemental Biologics License Application (sBLA) for the company’s blockbuster Fasenra (benralizumab), as a treatment for chronic rhinosinusitis with…
Three Democratic representatives from the House Committee on Oversight and Reform sent a letter to the Treasury Department and the Department of Justice (DOJ) Monday, expressing their alarm at certain…