CAJICA, Colombia – The Latin American biotech sector is scrambling in the midst of the COVID-19 pandemic, not only in coping with the outbreak, but also in finding the path to the future, while avoiding the pitfalls and looking for new opportunities ahead.
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acacia, Beigene, Biophytis Eusa, Geron, Metvital, Mundipharma, Napp, Rhythm.
Biosimilars referencing Amgen Inc.’s rheumatoid arthritis drug, Enbrel (etanercept), could remain sidelined in the U.S. for nearly another decade, following a Federal Circuit decision Wednesday affirming the validity of two patents protecting etanercept and its manufacturing methods.
The U.S. Department of Veterans Affairs (VA) is looking for more discounts from prescription drug manufacturers, but it likely will be a few years before the ask becomes reality as it will require congressional action and federal rulemaking.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian, Blueprint, EMD, Golden, Hangzhou Yuyuan, Isa, Janssen, Medicinova, Mezzion, Pfizer, Revive, Rhythm, Scpharmaceuticals, Sun, TC, Obseva, Ultragenyx, Y-mabs.
A month ahead of its PDUFA date, Ultragenyx Pharmaceutical Inc.’s NDA for triheptanoin (UX-007) won FDA approval. Branded Dojolvi, the highly purified, synthetic, seven-carbon fatty acid triglyceride was cleared for use in treating pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD), a group of rare and life-threatening genetic disorders in which the body is unable to convert long-chain fatty acids into energy.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.