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.
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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.
The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
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.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
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.
Are there other guidances the U.S. FDA should release as final without going through the draft and public comment process first? That’s one of the questions the FDA wants stakeholders to comment on as it updates its best practices for guidance.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
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