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.
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.
Intellectual property continues to be a pressing issue for makers of medical devices and diagnostics as demonstrated by the ongoing patent dispute between Alivecor Inc., and Apple Inc., which is being waged on multiple fronts. An administrative judge at the International Trade Commission (ITC) sided with Alivecor in the dispute, opening the door to an import ban while the Patent Trial and Appeal Board found that 20 of the claims in the disputed patent are unpatentable.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bresotec Medical, Imperative Care, Onconano Medicine, Sedana Medical.
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.
The U.S. FDA has released the special controls needed for extracorporeal carbon dioxide removal thanks to the successful pursuit of a de novo petition by Pittsburgh-based Alung Technologies Inc., but generating the clinical data for successor 510(k) devices will be no mean feat. While some of the associated in vivo testing may be performed on animal models, the list is extensive and includes testing for hemodynamic instability and inadequate gas exchange, all reasons that Alung and the FDA needed the better part of a decade to bring this device to the U.S. market.
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