As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
The EMA will require all new clinical trial applications to be submitted via its clinical trials information system after Jan. 31, 2023, despite pharma companies and other users raising concerns about functionality and technical failures they are experiencing with the system.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astrazeneca, Azafaros, Fabre-Kramer, Innovent, Jubilant, Lantern, Orchard, Revive, Sosei, Vaxcyte.
The process used by Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office PTO) to review patent disputes has become an issue yet again, thanks to a report by the Government Accountability Office (GAO). According to the GAO report, 75% of respondents to a survey of PTAB judges said that oversight practiced at PTO affected their independence in adjudicating cases, but that view was not universally held by these judges, leaving stakeholders with a vague picture as to the nature of the processes handled by the PTAB.
Upholding a 2021 jury verdict against a hedge fund adviser accused of making fraudulent statements to drive down Ligand Pharmaceuticals Inc.’s stock price, the U.S. Court of Appeals for the First Circuit shot down Gregory Lemelson’s arguments that his statements related to the company and its lead drug, Promacta (eltrombopag), were opinions protected by the First Amendment and that they were not material.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arugula, Bicycle, Biomarin, Checkpoint, Daiichi, Enlivex, IGC, Infex, Jasper, Kamada, Phathom, SFA, Surge, Tiziana, Transcenta.
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China.
After more than five years and extensive feedback, the U.S. FDA is finalizing its guidance on the format and content of risk evaluation and mitigation strategy (REMS) plans for prescription drugs and biologics associated with serious risks.
Phathom Pharmaceuticals Inc.’s shares sank 31% on news that the U.S. FDA will not take action on the company’s NDA for oral small-molecule potassium-competitive acid blocker vonoprazan by the Jan. 11 PDUFA date.
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