About two months ahead of the planned PDUFA date, the U.S. FDA has granted expanded approval of PD-1 antibody Jemperli (dostarlimab) from partners Anaptysbio Inc. and GSK plc for use in combination with standard-of-care chemotherapy. GSK said the drug would be the only frontline immuno-oncology treatment for endometrial cancer available in combination with carboplatin and paclitaxel. The supporting supplemental BLA for the expanded indication previously received priority review.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridgebio, Biohaven, Citius, GC, Harm Reduction, Invectys, Marinus, Merck & Co., Moberg, Nanjing Leads, Redhill, Spero, Transcenta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Gilead, Keros, Peptomyc.
Citius Pharmaceuticals Inc.’s retooled version of withdrawn cancer drug Ontak (denileukin diftitox) is not quite ready for prime time, according to the U.S. FDA, which issued a complete response letter (CRL) for the interleukin-2-diphtheria toxin fusion protein known as Lymphir. The agency is asking for Citius to incorporate enhanced product testing and additional controls but did not raise any concerns regarding safety and efficacy, the company said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Astrazeneca, Biohaven, Cessation, Defender, Jiangsu Recbio, Krystal, Precision.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Anova, Denovo, Incannex, Innocare, Inozyme, Myopax, Octapharma, Opthea, Pint.
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate.
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.
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.
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