The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo.
It didn’t take long for a U.S. district judge to grant Gilead Sciences Inc.’s request for a temporary restraining order to stop two interconnected health care networks in Florida from defrauding the company’s Advancing Access Medication Assistance Program that provides free HIV pre-exposure prophylaxis drugs to eligible, uninsured people.
The latest global regulatory news, changes and updates affecting biopharma, including: PhRMA: Broader response to trade barriers needed; Russia setting up drug purchasing center.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lianbio, Logicbio, Pharmacyte, XNK.
To say a lot is riding on the Nov. 3 presidential and congressional election in the U.S. would be an understatement, as the outcome could impact drug pricing, patent reform, research spending and pandemic response and preparedness.
When entrepreneurs and emerging businesses raise seed capital for a new business or generate funding for business growth, they often turn to the exempt offering framework under the Securities Act. However, when doing so, they are faced with a confusing and complex system that must be navigated. To simplify the process, the SEC has announced that it is amending its rules that govern offering exemptions, which small and medium-sized business rely on to raise capital.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Chemocentryx, Emmaus, Engene, Enlivex, Galapagos, Gensight, Gilead, Nanomab, Vifor Fresenius.
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
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