Claiming that convicted felon Martin Shkreli continues to exert control over Vyera Pharmaceuticals LLC from prison, the U.S. Federal Trade Commission (FTC) is seeking sanctions against the former hedge fund manager for intentionally destroying text and WhatsApp messages on his company-issued phone and a contraband phone years after he was instructed to preserve all documents potentially relevant to an ongoing antitrust investigation and litigation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Everest, Gamadelta, Kintor, Mindmed, Newron, Omeros, Propella, RDIF, Sorrento, Tenaya.
There’s been a change of plans. Following a preliminary review of briefing materials for a type C meeting, the FDA told Reata Pharmaceuticals Inc. that a pre-NDA meeting is instead the next best step in the development of omaveloxolone (RT-408) for treating Friedreich’s ataxia (FA).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Bioxcel, Genetx, Iovance, Myovant, Polypid, Reata, Ultragenyx.
A grueling day of congressional questions and accusations isn’t the end of a U.S. House Oversight Committee investigation into Abbvie Inc.’s pricing of blockbuster drugs Humira and Imbruvica.
In a rare move, the FDA disclosed summary trial information May 17 about Cytodyn Inc.’s Vyrologix (leronlimab), noting that currently available data don’t support the clinical benefit of the drug as a COVID-19 treatment.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Advicenne, Affyimmune, Biontech, Brii, Cytodyn, Eli Lilly, Innocare, Innovent, Kinnate, Merck, Pfizer, Qpex, Relief.
Now that Apellis Pharmaceuticals Inc.’s Empaveli pegcetacoplan has won FDA approval as the first targeted C3 therapy for treating paroxysmal nocturnal hemoglobinuria (PNH), the cost of treating the rare blood disorder is hefty.
The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions.