U.S. federal enforcement of the False Claims Act (FCA) violations tends to produce some outsized penalties, but the department isn’t shy about slapping six-figure fines on the smaller inhabitants of the med-tech space. DOJ reported that Schwenksville, Pa.-based Jet Medical Inc. and two affiliated companies will pay more than $745,000 to settle claims that Jet had introduced a nerve block device into interstate commerce without the FDA’s approval, a move that often draws the attention of federal government authorities other than the FDA.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Liberdi, Precision Biologic, Pristine Surgical, Vivos Therapeutics.
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.
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