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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, N.J. Read More
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. Read More
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that incorporate human genome editing (GE) on how best to communicate with the FDA about products in development in a draft guidance released yesterday. Read More
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 data monitoring committee recommended it do so. Read More
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 a pregnancy prevention program (PPM) or risk minimization measures (RMM). Read More
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 nasal polyps (CRSwNP). Read More
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 companies claiming tax benefits from their opioid settlement expenses. Read More
Nektar Therapeutics’ experimental immunotherapy bempegaldesleukin paired with Bristol Myers Squibb’s (BMS) blockbuster checkpoint inhibitor, Opdivo (nivolumab), did not shrink tumors, slow the growth of tumors or prolong survival rates for metastatic melanoma patients in a phase 3 trial in which the combo was compared to Opdivo alone. Read More
Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Read More