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 has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration.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.
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avencell, Biocon, Hanchorbio, Keros, Mabwell, Molecure, Nectero, Overland, Polpharma, Replay, Verrica.
The U.S. Court of Appeals for the Federal Circuit declined an invitation in United Therapeutics Corp. v. Liquidia Technologies Inc. to expand the enablement and written description bar for biopharma claims into the realm of regulatory approval.
The U.S. FDA has approved the first treatment directly targeting the mites that cause Demodex blepharitis, an eye disease shared by about 25 million people in the U.S. and now a huge market opportunity for the developer.
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