Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
Krystal Biotech Inc. has received FDA acceptance of its IND application for lead oncology drug candidate KB-707 for the treatment of locally advanced or metastatic solid tumor malignancies. KB-707 is a modified herpes simplex virus 1 (HSV-1) vector designed to deliver genes encoding both human IL-12 and IL-2 to the tumor microenvironment and promote systemic immune-mediated tumor clearance.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Hope Vision, Numares.
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
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.
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