Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Just three days before the U.S. CDC’s reconstituted Advisory Committee for Immunization Practices (ACIP) is scheduled to discuss and possibly vote on the COVID-19, hepatitis B and MMRV vaccines, Health and Human Services Secretary Robert Kennedy added five new members to the panel.
Two months after it was launched, the wheels are coming off the U.K. government’s 10-year life sciences strategy, with pharma companies withholding promised capital investments in protest at the row over drug pricing. Merck & Co. Inc., Astrazeneca plc and Eli Lilly and Co. Inc. have said they are not going ahead with previously announced investments.
Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.
When it won U.S. FDA accelerated approval more than eight years ago, Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was viewed as a breakthrough, becoming the first new treatment in 20 years for rare, progressive liver disease primary biliary cholangitis (PBC) and, for several years, the only second-line treatment for PBC patients failing to respond to ursodeoxycholic acid. More recently, however, Ocaliva has faced regulatory and safety stumbles, with Intercept now voluntarily pulling the farnesoid X receptor activator from the U.S. market.
The debate around the U.S. 340B prescription drug discount program is once again heating up in court and in Congress. A day after the American Hospital Association called on the FTC and Department of Justice to investigate alleged antitrust issues with the rebate models a few drug companies have proposed, some members of Congress raised concerns Sept. 9 about how providers are abusing the program. Meanwhile, a U.S. appellate court heard arguments that same day on whether states can speak in the silence of the federal law that created the program more than 30 years ago.
The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
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