Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aeglea, Algotx, Evofem, Gamida, Iaso, Innovent, Myovant, Opiant, PDS, Pfizer, Takeda.
Drug and device makers are necessarily wary of any activities that could lead to prosecution under the False Claims Act (FCA), but seemingly innocuous activities are now fair game for federal prosecutors. The latest example is the FCA prosecution of Caris Life Sciences for filing claims for cancer tests outside the 14-day post-discharge window, and Mark Gardner, directing attorney at Gardner Law of Stillwater, Minn., told BioWorld that device makers should be on the alert because it appears that federal authorities are ramping up enforcement.
Shares of Aeglea Biotherapeutics Inc. tumbled 51% June 2 on news that it received a refusal to file (RTF) letter from the U.S. FDA regarding the BLA for pegzilarginase for the treatment of arginase 1 deficiency, with the agency requesting additional efficacy data.
Following an investigation into Leadiant Group’s pricing of a rare disease drug, the Italian Competition Authority fined the privately held company about €3.5 million (US$3.76 million) May 31 for charging the Italian National Health Service excessive prices since 2017 for Chenodeoxycholic Acid Leadiant.
Suzhou, China-based Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange (HKEX:02616) after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow, Lumiradx, Net Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Codagenix, Eagle, Foresee, Hutchmed, Kashiv, Kymera, Mezzion, Midatech, Neuronascent, Roche, Sanofi, Swedish Orphan, Teon, TG, UCB, VBI.
The U.S. Cybersecurity & Infrastructure Security Agency (CISA) said the Synapsys microbiology informatics software platform has an access vulnerability due to an inadequate session expiration mechanism. Becton, Dickinson & Co. (BD), the publisher of the Synapsys system, said three versions of the software are vulnerable, but this vulnerability can be exploited only by those with direct access to the workstations, making this a lower risk than some other recently reported vulnerabilities.
Pivotal in killing the Biden administration’s Build Back Better budget legislation, Sen. Joe Manchin (D-W.Va.) is now working to revive parts of it, including the provision that would require Medicare to directly negotiate prescription drug prices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Burning Rock, Genetron, Novacyte, Royal Biologics, Saneso, Stratipath.
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