The conditional marketing approval for Ocaliva (obeticholic acid) has been revoked with immediate effect, following a standoff between the EMA and Advanz Pharma Ltd., the company that markets the primary biliary cholangitis (PBC) therapy in Europe. On Sept. 5, London-based Advanz won a short reprieve after challenging the EMA’s June 28 ruling that the marketing authorization for Ocaliva should be revoked, when the General Court of the EU granted a temporary suspension of EMA’s decision. However, on Nov. 27, Advanz announced the court had said it would not be extending the suspension.
The health care potential for generative artificial intelligence comes with hazards such as the inadvertent effects of poor prompt engineering practices, but Anil Bhatta of Deloitte Consulting told a U.S. FDA advisory committee that this risk could be managed by rules that would thwart any consequent problems, such as an inadvertent jailbreak of the algorithm’s intended use.
Longbio Pharma (Suzhou) Co. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for LP-003, the company’s next-generation anti-IgE antibody, to enter a clinical trial for the treatment of food allergy.
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.
The Ministry of Food and Drug Safety (MFDS) approved South Korea’s first denosumab (Prolia/Xgeva) biosimilars, developed by Celltrion Inc. under the brand names of Stoboclo/Osenvelt (CT-P41) for respective indications, a move the company hopes will help secure first-mover advantage for the drugs, currently under review in the U.S. and Europe.
When U.S. CMS Administrator Chiquita Brooks-LaSure announced Nov. 26 that the agency is “reinterpreting” the law in proposing a rule allowing Medicare and Medicaid to cover obesity drugs beginning in 2026, she called it a “historic step.” The rule, if finalized, could make obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) available to millions more Americans and further invigorate development of other obesity drugs. But given the lateness of the day in the Biden administration, the proposal may be more symbolic than historic.
The first day of the U.S. FDA’s two-day advisory hearing on generative artificial intelligence reflected some of the anxieties attached to this emerging technology, with the phenomenon of hallucinations driving several calls for more stringent regulation of this class of products that might be applied toward other entries in the class of artificial intelligence.
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
With the U.S. FDA approval of Attruby (acoramidis) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), Bridgebio Pharma Inc. is taking on an industry giant. The next-generation, oral, small-molecule stabilizer of transthyretin will take on Pfizer Inc.’s Vyndamax (tafamidis, Vyndaqel), a TTR stabilizer approved in 2019 for ATTR-CM but expected to lose exclusivity in late 2028. The approval was based on a phase III study that showed Attruby significantly reduced death and cardiovascular-related hospitalizations. The NDA, which had a Nov. 29 PDUFA date, was approved Nov. 22.
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