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A trio of trade associations representing cell and gene therapy developers are urging the European Commission (EC) to permanently exempt their member state companies’ products from genetically modified organism (GMO) legislation in the EU. Read More
Chinese pharma company Sinopharm has two COVID-19 vaccines that appear to be safe and effective, according to a new study published in the Journal of the American Medical Association (JAMA). Read More
Amgen’s potential blockbuster cancer drug Lumakras (sotorasib) has secured the FDA’s approval for the treatment of adults with nonsmall-cell lung cancer (NSCLCs) whose tumors contain the KRAS G12C gene mutation and who have received at least one prior line of therapy. Read More
The Government Accountability Office (GAO), in a letter to the HHS secretary, has reiterated that the agency needs to continue to prioritize its inspections backlog. Read More
The FDA has issued a complete response letter (CRL) to Eton Pharmaceuticals over its dehydrated alcohol injection for treating methanol poisoning, saying it could not approve the company’s New Drug Application (NDA) at this time. Read More
Pharmaceutical experts sitting on advisory committees in the U.S. and UK aren’t required to disclose conflicts of interest dating back more than a year and differing public disclosure standards among entities can cause important industry ties to go unreported to the public, according to The BMJ. Read More
The FDA has approved Myovant Sciences’ and Pfizer’s estrogen-based hormone therapy, Myfembree, for the treatment of heavy menstrual bleeding associated with uterine fibroids, the first once-daily regimen for the condition, according to the companies. Read More
Provention Bio’s teplizumab, a monoclonal antibody the FDA is reviewing for delaying or preventing type 1 diabetes, should be approved because the benefits outweigh the risks, a divided Endocrinologic and Metabolic Drugs Advisory Committee said Thursday in a 10-7 vote. Read More