Making them an antibiotic of last resort, the U.K.’s Medicines and Healthcare Products Regulatory Agency introduced new restrictions on the use of fluoroquinolones due to the risk of potentially long-term or irreversible side effects.
With little fanfare, the Biden administration dropped its appeal Jan. 16 of a recent court decision that vacated a 2021 U.S. Health and Human Services rule permitting health insurance issuers and group health plans to use so-called copay accumulator adjustment programs that prevent drug manufacturers’ copay assistance from counting toward a patient’s deductible or out-of-pocket maximum.
Is it an unconstitutional taking when U.S. FDA reviewers disclose a brand company’s claimed trade secrets or confidential commercial information to would-be competitors? That’s a question the U.S. Court of Federal Claims has yet to answer. While the court dismissed some of Vanda Pharmaceuticals Inc.’s claims against the FDA, its Jan. 18 opinion left open the debate of whether such disclosures, intentional or inadvertent, are a per se or regulatory taking.
U.S. Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, is not taking no for an answer after the CEOs of Johnson & Johnson (J&J) and Merck & Co. Inc. declined an invitation to appear before the committee to explain their U.S. drug prices.
The U.S. FDA’s Jan. 5 approval of Florida’s plan to import prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between senior U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
California’s First District Court of Appeal opened an avenue, in that state at least, for lawsuits against drug and device companies based on their pipeline development priorities.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
With its approval Jan. 5 of Florida’s drug importation program, the U.S. FDA ended a 23-year wait for the government to implement a 2000 provision allowing certain prescription drug imports from Canada.