Daiichi Sankyo Co Ltd. has experienced yet another setback with its quizartinib NDA submission, as the U.S. FDA has now extended the review period by three months to July 24, 2023, to allow additional time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies.
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer.
Xian Janssen Pharmaceutical Ltd. obtained marketing approval in China for Spravato (esketamine hydrochloride nasal spray) in combination with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Unlike existing antidepressants on the market, which can take weeks to take effect, the newly approved nasal spray shows effects right away.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, Avidity, Bluebird, Bridge, Kancera, Lantheus, Maat, Moderna, Sanofi, Soligenix, Xbrane.
The U.S. Supreme Court has handed down a broadly unanimous decision that allows the targets of Federal Trade Commission (FTC) enforcement action to appeal that action to federal district court prior to the conclusion of the agency’s review or enforcement process. The outcome could prove a boon to life science companies that may now challenge FTC actions against mergers and acquisitions prior to the conclusion of that action, a point at which the company’s options have narrowed drastically.
Avanos Medical Inc. recalled 1,000 units of two of its Ballard Access suction systems for use in clearing artificial airways in neonatal and pediatric patients because of multiple complaints of cracked device manifolds. The recall affects 1,000 units distributed in the U.S. between October 2022 and January 2023, but this is the second recall of Avanos products in less than a year.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is a groundbreaking guidance that was enabled by legislation that allows the filing of PCCPs with all device types, not just software as a medical device (SaMD). However, a member of the FDA team acknowledged recently that this new approach to device change management could require that the agency revisit existing guidances such as a guidance for when to file a new regulatory submission for 510(k) devices, thus heralding a series of guidance revisions that may take several years to unwind.
Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Route 92 Medical, Yourbio Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Bristol Myers Squibb, Daiichi Sankyo, Incyte, Xortx.
RSS
