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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Athenex, Evaxion, Gilead, Hotspot, Janssen, Legen, Orasis, Profoundbio.
Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Beigene, Calliditas, Everest, Mediwound, Merck & Co.
U.S. FDA approvals in 2022 are down by 31.3% compared with last year and clearances for new molecular entities are at the bottom of all recent years. As of Dec. 20, the agency had approved 143 drugs and biologics in 2022, including supplemental filings, just slightly higher than the 138 approvals in 2016, but far behind the 208 approvals recorded in both 2021 and 2017.
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
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