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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Defender Safety.
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.
It looks like the two biosimilars referencing Amgen Inc.’s Enbrel (etanercept) will have to wait out the rest of the decade before launching in the U.S. The U.S. Supreme Court declined May 17 to hear Sandoz Inc.’s appeal of last year’s split Federal Circuit ruling affirming the validity of two patents protecting etanercept and its manufacturing methods
Song Guo Zheng, a rheumatology professor and researcher at Ohio State University (OSU), was sentenced May 14 to 37 months in prison for lying on U.S. NIH grant applications about his ties to at least five Chinese research institutes.
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics.
As part of its ongoing investigation into what it considers excessive price increases for some prescription drugs, the U.S. House Oversight Committee plans to put Abbvie Inc. CEO and Chairman Richard Gonzalez on the hot seat May 18 for a grilling on the company’s pricing of Humira and Imbruvica.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
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