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Shareholders of the U.S.’ big three COVID-19 vaccine makers have voted no on proposals asking the companies to share their intellectual property with low- and middle-income countries (LMICs) so that those countries could make their own versions of the vaccines. Read More
Trials of drugs to treat Crohn’s disease should add reduction of intestinal inflammation to their symptom-relief endpoints, according to an FDA draft guidance released Thursday in tandem with a draft guidance for conducting ulcerative colitis trials. Read More
Amgen disclosed this week that the Internal Revenue Service (IRS) is seeking $7.1 billion in back taxes and fines relating to how the drugmaker split profits between its U.S. and Puerto Rican manufacturing hubs. Read More
The FDA needs funding for technological advancements and updated infrastructure, buildings and facilities, Commissioner Robert Califf told a Senate subcommittee discussing the agency’s fiscal year 2023 budget requests. Read More
The potential blockbuster drug has also received the FDA’s accelerated approval for the treatment of unresectable or metastatic HER2-positive breast cancer. Read More
The FDA is seeing “new lows in data integrity” relating to generic drug applications, an agency official said at the agency’s two-day Generic Drugs Forum 2022, April 26-27. Read More
The FDA has issued warning letters to five drugmakers producing several products including topical anesthetics, skin-bleaching products and hand sanitizers. Read More