Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Bellus, Byondis, Citius, Cyxone, Dyne, Fresenius, Greenwich, Novartis, Y-mabs.
Legislation that would renew the U.S. FDA’s user fee programs is stuck in process on Capitol Hill, a predicament that seems to resist resolution to date. FDA commissioner Robert Califf said on a July 12 webinar that the FDA “is a decision-making machine” that is reliant on both user fees and congressional appropriations, and that a failure on the part of Congress to act on user fee legislation may force the agency to halt new hires and possibly lay off some FDA staff.
The revised Build Back Better bill Democrats in the U.S. Senate are looking to pass in the next few weeks could deliver savings of $18 billion to $24 billion per year from 2028 through 2031 through drug pricing reforms that include direct Medicare price negotiations, according to a Congressional Budget Office estimate.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anthos, Arcutis, Can-Fite, Iterum, Lipocine, Perrigo, Pfizer, SCG.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alimera, Horizon, MGC, Puma, Siga.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Another biopharma consultant got on the wrong side of the U.S. SEC for insider trading. To resolve the allegations, Hugh Lee Sweeney, a longtime consultant for Catabasis Pharmaceutical Inc., agreed to a cease-and-desist order, disgorgement of $57,931 and prejudgment interest of $2,499.71, and civil penalties of $57,931.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Annovis, Bausch + Lomb, Clovis, Diamedica, Innocare, Pfizer, Xortx.
A few weeks ago, the odds of the deeply divided U.S. Congress passing drug pricing reforms that would allow direct Medicare negotiation seemed pretty slim. But those odds improved significantly July 6 when Senate Democrats reached a compromise on their version of the pricing provisions included in the Build Back Better bill, H.R. 5376, passed by the House last November.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
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