The U.S. Senate held a July 25 hearing on the need for regulation of artificial intelligence (AI), which highlighted an interest in a single overarching agency that would direct any regulations promulgated for AI across the U.S. economy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied, Avenue, Boehringer Ingelheim, Eli Lilly, Larimar, Mirum, Pfizer, Sinopharm, Tarsus, Viiv Healthcare.
Following a comment-and-review process waylaid by the COVID-19 pandemic, the U.S. FTC is finalizing its revised guides on the use of endorsements and testimonials in advertising.
A British billionaire who’s the founder and principal owner of the Tavistock Group, an international private investment fund with a portfolio that includes biotech companies, was arrested July 26 on multiple criminal charges of U.S. securities fraud, along with two private pilots whom allegedly received insider tips from him in lieu of a formal retirement plan.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baropace, Imperative Care, Numares.
Advocates are pressing the U.S. Congress to pass legislation to require more Medicare coverage of telehealth and telemedicine, but the Office of Inspector General (OIG) continues to report instances of fraud in this area. OIG reported July 24 that government attorneys had forced a guilty plea out of a telemedicine provider who has agreed to pay $44 million to deal with charges of fraud perpetrated over a period of three and a half years.
The U.S. Federal Trade Commission (FTC) has been exceptionally active in the mergers and acquisitions space for the past 18 months, but Congress might soon amplify these agencies’ ability to suppress these transactions. Sen. Amy Klobuchar (D-Minn.), who chairs the competition subcommittee of the Senate Judiciary Committee, said in a recent hearing that vertical mergers have flown largely off the enforcement radar, a problem that Congress could address by several means, including by providing the FTC with a heftier budget to pursue these cases.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
South Korea’s antitrust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down on 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program.
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