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. Read More
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. Read More
Oxurion NV, which had spent much of 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 part B of the phase II Kalahari study. Read More
Bayer AG’s asundexian, considered one of the next generation class of anticoagulants and a potential blockbuster, has failed a phase III clinical trial in atrial fibrillation. The factor XIa inhibitor is one of three with a similar mechanism of action in late stage development by big companies. Read More
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. Read More
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 in patients with malignant pleural mesothelioma. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Adlai Nortye, Asklepios, Karuna, Medicenna, Sapience. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2518542, Abliva, Acer, Astex, Astrazeneca, Avonlea-Drewry, Basilea, Bayer, Biosyent, Chiesi, Chr. Hansen, Gryphon, Haisco, Khiron, Mira, Miralogx, Neuren, Novozymes, Pfizer, Rion, Owl, Tracon and Zevra. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Astellas, Astrazeneca, Beigene, Kanna, Merck, Pfizer, Polaris, Sana, Teva. Read More
