Whether it’s legislation calling for more transparency from pharmacy benefit managers (PBMs) or hearings held in search of a new roadmap to modernize the U.S. drug supply chain, Congress is scrutinizing and looking to clamp down on the role PBMs are playing in raising drug prices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Blueprint, Eloxx, Epicentrx, Hansa, Juno, Pharmather, Regeneron, Transcenta.
U.S. FDA commissioner Robert Califf went to Capitol Hill ostensibly to answer questions about the agency’s budget request for fiscal 2024, but the conversation quickly focused on issues such as baby formula and food supply security.
U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, BMS, CSL, Ionctura, Maat, Thermosome, Tiziana.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Brainstorm Cell, Cyclerion, Genentech, Incyte, Iovance, Oncology.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro).
A lot of eyes and ears were tuned to the U.S. Supreme Court’s March 27 argument in Amgen Inc. v. Sanofi SA with its focus on how much enablement is necessary in broad genus patent claims.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boehringer Ingelheim, Henlius, Incyte, Janssen, PTC.
Pharming Group NV’s stock skyrocketed March 24 on news that the U.S. FDA approved Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS) for those ages 12 and older. The nod, which came a few days ahead of the March 29 PDUFA date, sent shares (NASDAQ:PHAR) up 33%, or $3.69, to end the day at $14.96.
RSS
