Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTI, Diurnal, I-Mab, Iterum, Janssen, Johnson & Johnson, Lantheus, Regenxbio.
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.
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.
A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the new therapy approved for Americans with HES in nearly 14 years, according to the FDA. An EMA filing in HES is expected later this year.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aligos, Apollomics, Aquestive, Avrobio, Biomed Valley, Cipla, CSL, FSD, Gilead, Glaxosmithkline, Heron, Huya, Inceptua, Inovio, Khondrion, Orchard, Shionogi, Stemedica, Xcures.
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