Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cepheid, Conformis, Guide Sensmart, Oxford Immunotec, Surgical Innovation Associates.
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd., a subsidiary of Roche Holding AG, has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) to add new indication to the list of those treatable with its combination of Tecentriq (atezolizumab) and Avastin (bevacizumab): unresectable hepatocellular carcinoma (HCC). Both medicines originated at Genentech Inc.
The governor’s signature brought California a step closer to realizing state officials’ dream of having their own generic and biosimilar drug label. In signing the California Affordable Drug Manufacturing Act into law Sept. 28, Gov. Gavin Newsom touted the legislation as a way to break down market barriers to affordable prescription drug prices. “Our bill will help inject competition back into the generic drug marketplace – taking pricing power away from big pharmaceutical companies and returning it to consumers,” he said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Aerie, Ascendis, BMS, Bridgebio, Histogen, Infinity, Medimetriks, Neuren, Organicell, Otsuka, Painreform, Pfizer, Seed Health, Windtree.
The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
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