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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In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 31.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
The U.S. Department of Justice (DOJ) has issued a subpoena to Eli Lilly, seeking documents related to its Branchburg, N.J., manufacturing plant, the site of employee whistleblowing that alleged quality control failures and the editing of certain findings to make them appear less serious. Read More
Less than 40 percent of clinical trials active in ClinicalTrials.gov over the past four years were in compliance with FDA reporting requirements, a new analysis of the federal database revealed. Read More
The Biden administration has reinstated the FDA’s Unapproved Drugs Initiative (UDI) that was shelved late last year in an HHS notice now being described as “legally and factually inaccurate.” Read More
The FDA has placed Larimar Therapeutics’ phase 1 trial of its experimental Friedrich’s ataxia drug, CTI-1601, on clinical hold, a significant setback for the company as the recombinant fusion protein is the only drug candidate in its pipeline. Read More