Device makers may see privacy legislation in California and other U.S. states as a source of regulatory balkanization, but that very same problem is cropping up in the international arena. In addition to the European General Data Protection Regulation (GDPR), privacy requirements are popping up in Brazil and elsewhere, and Eric Bowlin, a partner at Deloitte Risk & Financial Advisory, told attendees on a virtual symposium that the best approach might be to base a compliance program on general principles.
HONG KONG – Daiichi Sankyo Co. Ltd. has won regulatory approval for Enhertu (trastuzumab deruxtecan) in Japan based on a pivotal phase II trial alone. The HER2-directed antibody-drug conjugate has been approved for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.
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.
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