The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bloomsbury, Lantern, Merck & Co., Neobiosis, Pharmala, Phathom.
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Anthos, Astellas, Astrazeneca, Crispr, Praxis, Sanofi, Vertex, Vor.
Eisai Co. Ltd. and Biogen Inc.’s Leqembi (lecanemab) gained the support of the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom) in a 6-0 vote on June 9, as panel members unanimously agreed that the results of the phase III Clarity trial verified the clinical benefit in the treatment of Alzheimer’s disease. The FDA does not have to follow the adcom’s recommendation, but it often does. The PDUFA date for the supplemental NDA is July 6.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Eisai, Innate, Merck & Co., Novaliq, Pipeline, Rocket.
The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season.
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capricor, Dtx, Itabmed, Janssen, Legend, Med-Life, Merz, Onquality.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphera, Brainstorm, Fennec, GSK, Merck & Co., Quralis, Tscan, Vyluma.
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