Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ion Beam, CMI, Life Molecular, Rapid Medical, Xpan.
The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.
Immuneering Corp. has obtained FDA clearance of its IND application for IMM-6-415, an oral, twice-daily small molecule in development for the treatment of advanced RAF or RAS mutant solid tumors.
Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-564 for the treatment of solid tumors.
Sanofi SA backed out of its $750 million effort to advance Maze Therapeutics Inc.’s oral Pompe disease candidate, MZE-001, after the U.S. FTC filed a federal lawsuit to block the deal, claiming the Paris-based firm was seeking to eliminate a nascent competitor.
China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
The qui tam or whistleblower lawsuit under the U.S. False Claims Act (FCA) has driven a large volume of litigation against life science companies, but three Supreme Court justices expressed misgivings about the constitutionality of the qui tam relator in the Court’s hearing of Polansky. Should a fourth Supreme Court justice harbor similar misgivings, the matter could be ripe for a hearing at the Supreme Court with the possibility that the qui tam relator would then be declared unconstitutional.
The European Union’s Artificial Intelligence Act (AI Act) is widely seen as a groundbreaking piece of legislative handiwork, but companies in the life sciences may see it as a groundbreaker with negative consequences. The latest edition of the AI Act continues to treat medical AI software as a high-risk product, which would make these products exceptionally expensive and burdensome to bring to market in the EU and convince some companies in the medical AI business to skip the European market altogether.
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