The U.S. FDA has granted breakthrough device designation to Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine. The designation, which provides for priority review and consultation with the agency on product development, underscores the need for effective treatments for the costly and debilitating condition. According to a summary in a patent filing, the wireless system comprises a treatment pulse generator unit and an implantable electrode unit to provide neurostimulation therapy for headaches.
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.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
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.
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