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Bufferin, a brand synonymous with aspirin for many consumers, features in a head-scratcher FDA action as the agency withdraws the product’s 1948 NDA because the named manufacturer has failed to file required multiple annual reports on the prescription drug, which hasn’t been marketed for years. Read More
A tornado with winds of 150 mph slammed into Pfizer’s enormous drug manufacturing plant in Nash County, N.C., on July 19, knocking out the facility that makes 25 percent of the company’s injectable medications. Read More
Five drugs that are likely to make the Inflation Reduction Act (IRA) price negotiation list accounted for 13 percent ($29 billion) of 2021 Medicare Part D spending, but were less than one percent of all covered drugs according to a Kaiser Family Foundation (KFF) analysis of the latest available sales data from CMS. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
Republican members of the House Energy and Commerce (E&C) Committee are pressing FDA Commissioner Robert Califf on the effectiveness of the agency’s foreign drug inspection program given that numerous Indian and Chinese firms have repeatedly flouted FDA regulations. Read More
Two more drugmakers — Johnson & Johnson’s Janssen Pharmaceuticals and Astellas Pharma — filed lawsuits this week against CMS seeking relief from the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA), claiming the program is unconstitutional and bringing the number of lawsuits filed to six. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
The Department of Justice (DOJ) and the FTC have issued draft guidelines the government will use to determine whether a merger may violate anti-trust laws by risking lessened competition now and in the future. Read More
Teva Pharmaceuticals is facing Department of Justice (DOJ) allegations — and potential penalties of $12 billion — that the Israeli drugmaker defrauded Medicare by paying kickbacks to charitable foundations that subsidized patients’ out-of-pocket payments for its multiple sclerosis blockbuster Copaxone (glatiramer). Read More