Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, industry prepare for vaccine; FDA updates trial guidance; Labeling changes for diabetes drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alligator, Biocryst, Engene, Johnson & Johnson, Novo Nordisk, PTC.
As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year.
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.
The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Antengene, Emmaus, Engene, Eyenovia, Genmab, Janssen, Neurogene, Ose, Realta, Rezolute.
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
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