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.
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.
A British billionaire who’s the founder and principal owner of the Tavistock Group, an international private investment fund with a portfolio that includes biotech companies, was arrested July 26 on multiple criminal charges of U.S. securities fraud, along with two private pilots whom allegedly received insider tips from him in lieu of a formal retirement plan.
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.
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