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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
Sanofi and GlaxoSmithKline have begun enrolling participants in a global phase 3 trial of their COVID-19 vaccine candidate that could potentially lead to a regulatory approval in the fourth quarter of 2021. Read More
PhRMA has filed a lawsuit against HHS, pushing back against a final rule that the trade group contends would penalize drug manufacturers that provide financial assistance to patients. Read More
In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 31. The next issue will be published Tuesday, June 1. Read More
GlaxoSmithKline’s (GSK) and Vir Biotechnology’s monoclonal antibody sotrovimab has secured FDA Emergency Use Authorization (EUA) for treating mild-to-moderate COVID-19 in patients 12 years and older at high risk of progressing to severe disease. Read More