In October, U.S. FDA approvals experienced a significant upswing, reaching a total of 27 for the month, a 92.86% increase from 14 approvals recorded by BioWorld in September. In the initial 10 months of this year, FDA approvals hit 155, an increase of 22.05% from the 127 drugs approved last year, although approvals are down from 2018-2021. Approved new molecular entities are at 29 in 2023, up from 28 in the corresponding period last year but a decline from 2017-2021.
The long-running row over the U.K. voluntary scheme that controls the national drugs budget has been settled, in what the industry is describing as a “tough deal.” Under the scheme there is an annual cap on total sales of branded drugs to the National Health Service, with sales over the agreed limit reimbursed via a levy. In 2022, pharma companies paid back £2 billion (US$2.5 billion) in rebates on total sales of £14 billion. In the new five-year agreement, the allowed annual increase in sales will be 2% in 2024, the same as across the current scheme from 2019 – 2023, but it will then increase to 4% by 2027.
Janet Woodcock, one of the longer-tenured U.S. FDA center directors in the agency’s history, is set to retire sometime in 2024, although the exact date has not been set.
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
Low expectations on Wall Street for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) sit-down on Merck & Co. Inc.’s P2X3 receptor antagonist gefapixant for chronic cough (CC) translated to negative balloting by panelists. PADAC members were polled on a single question: Does the evidence demonstrate that [Merck’s] gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained CC? The results came out 12 no, 1 yes.
Along with Enhertu, Astrazeneca plc now has another breast cancer treatment in its portfolio and it may also become a blockbuster. Truqap (capivasertib), combined with the company’s Faslodex (fulvestrant), is now U.S. FDA-approved for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
With a landmark U.K. approval in hand for Casgevy (exagamglogene autotemcel [exa-cel]) to treat sickle cell disease and transfusion-dependent beta thalassemia, Crispr Therapeutics AG and partner Vertex Therapeutics Inc. are turning their attention to the PDUFA dates set by the U.S. FDA for the treatment in both conditions.
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer.
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