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.
Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery.
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medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
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: HHS announces testing agreements; TGA slaps two companies for violations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brighter.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CSL, DBV, Chiesi, Imugene, Innocare, Innovation, Janssen, Neuraly, Pharmaxis, Polarityte, Poseida, Provention, Roche, Senhwa, Taigen.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada prepares for resurgence of COVID-19 shortages; Russia sets drug pricing structure.
The U.S. FDA is no longer reviewing lab-developed tests (LDTs) under the emergency use authorization (EUA) program, which eliminates product liability protection for them under the Public Readiness and Emergency Preparedness (PREP) Act. Harvard’s Michael Mina said on an Oct. 30 press briefing that the PREP Act question could be extended to LDTs administratively even outside EUA review, a move he said is under consideration based on his communications with Assistant Secretary for Health Brett Giroir.
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.
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