A twisted, uncertain path has led to a U.S. FDA approval for Biogen Inc.’s Qalsody (tofersen), the first drug targeting a genetic cause of amyotrophic lateral sclerosis (ALS). Qalsody is for ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. Patients with SOD-1 mutations account for 2% of ALS cases.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carl Zeiss Meditec, Insulet, Proprio.
The U.S. Supreme Court has declined to hear a case that tests the notion that artificial intelligence (AI) can be an inventor, a development that may be nothing more than the beginning of the AI-as-inventor story under U.S. law. The Patent and Trademark Office’s (PTO) April 25 webinar on the subject included some remarks that AI could be used to produce a tsunami of potentially duplicative patent applications, but the event demonstrated that there is almost no at-large support for AI-as-inventor, suggesting that the status quo will stand for the time being.
As it requested, the U.S. FDA got an earful April 25 as people with long COVID and their caregivers shared their experiences with the condition that has no approved, or even authorized, treatment and is not that well understood, given its range of symptoms that vary from person to person.
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.
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