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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Adamis, Algernon, Apellis, Diamedica, Everest, Icanomab, Immunitybio, Ix, Kiromic, Mindmed, Pharmather, RDIF.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Astellas, Bridgebio, Creative Medical Technology, Pharmaessentia.
The potential for using real-world data (RWD) to support the development of cancer drugs for children has yet to be realized as researchers, sponsors and regulators continue to struggle with the collection of meaningful data.
More than 150 U.S. patents could be at stake if the World Trade Organization (WTO) were to adopt an intellectual property waiver as originally proposed by India and South Africa.
It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the approval comes with a less broad label than Heron would have liked. Zynrelef (bupivacaine and meloxicam), which had a May 12 PDUFA date, is approved for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annovis, Antengene, Ascendis, Heron, Palisade, RDIF, Strongbridge.
It came as no surprise May 12 that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, to recommend the use of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), in 12- to 15-year-olds following the FDA’s decision earlier this week to expand the vaccine’s emergency use authorization (EUA) to that age group.
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