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 (NHS), 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. The increase in the NHS branded drugs budget this incurs will in part be paid for by increasing the rebate on prescription generic drugs. This will increase from 10% at present to up to 35%, with the exact rate depending on to what extent competition between suppliers leads to price reductions. The move to weight the scheme in favor of branded drugs over generics will make the 2024 – 2028 deal “explicitly pro-innovation and pro-competition,” the Association of British Pharmaceutical Industries said in a statement.

FDA announces Janet Woodcock’s plan to retire in 2024

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. Woodcock’s departure leaves a gaping hole in the FDA’s body of experience in drug regulation, a problem made clear by the extended timeline of her retirement and the associated timeline for a search for her replacement. FDA Commissioner Bob Califf said Woodcock is “a legend in every sense of the word,” and that he would “share news about her successor in the future.”

Oxurion to file for bankruptcy after latest phase II DME trial miss

Oxurion NV, which had spent 2023 scraping together funding in hopes of a positive readout for its bicyclic peptide, THR-149, in diabetic macular edema (DME), now faces a bankruptcy filing after the drug failed to best established anti-VEGF therapy aflibercept (Regeneron Pharmaceuticals Inc.) in improving vision in the phase II Kalahari study. Originally founded in the 1990s as Thrombogenics, the Belgian firm had hoped to improve on available treatment approaches for ocular diseases. But its only approved product, Jetrea (ocriplasmin), proved a commercial disappointment, and its other clinical-stage DME candidate, THR-687, missed its endpoint in a May 2022 readout.

Bayer stumbles in blood thinner’s phase III 

Bayer AG’s factor XIa inhibitor asundexian, considered one of the next-generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial. The Oceanic study of atrial fibrillation (AF) in patients at risk of stroke comparing asundexian with Eliquis (apixaban), the standard of care, was stopped early by an independent data monitoring committee due to inferior efficacy. The committee recommended however that Bayer continue its phase III Oceanic study of asundexian in patients with AF who are age 65 years or older and at high risk for stroke or systemic embolism and who are ineligible for oral anticoagulation treatment. Asundexian was granted fast track designation from the U.S. FDA for treating stroke and systemic embolism in AF in May.

US FDA approves 27 drugs in October, marking highest month since 2020

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. October was a landmark month for FDA approvals, with 27 drugs greenlighted, the highest month of approvals since 29 approvals in June 2020.

Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma 

Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival (PFS) in patients with malignant pleural mesothelioma (MPM).

Also in the news

Abbvie, Abliva, Adlai Nortye, Almirall, Askbio, Astellas, Astex, Astrazeneca, Basilea, Bayer, Beigene, Biosyent, C4, Cantai, Carmot, Chiesi, Day One, Dermata, Diakonos, Gradalis, Haisco, Kanna, Karuna, Khiron, Maia, March, Medicenna, Merck, Mira, Neuren, Novozymes, Oncopeptides, Owl, Pfizer, Polaris, Rakovina, Rion, Sana, Sapience, Teva, Theralase, Tracon, Viva, Zevra