A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.”
In an ongoing sibling saga of biopharma trade secret theft, Gongda Xue, a Swiss resident and Chinese citizen, has been convicted, following a U.S. trial, of charges related to a conspiracy to steal trade secrets from Glaxosmithkline plc over a six-year period beginning in 2010, the U.S. Attorney’s Office for the Eastern District of Pennsylvania reported May 2.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Isono Health, Mirvie, Spinex, Strados, Suneva Medical, X-Therma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Axsome, Biogen, Coherus, Horizon, Hutchmed, Ideaya, Junshi, Moderna, Myovant, Novavax, Regeneron, Sage, Supernus, Vaxxinity, Vertex, Vitti.
Bridge to Life Ltd. has won FDA breakthrough device designation for its Lifecradle Heart Preservation Transport System enabling clinicians to affordably implement hypothermic oxygenated perfusion of heart grafts during organ transport. Lifecradle employs a “plug-and-play” design to differentiate it from historic static cold storage but also from “normothermic” preservation which provides oxygen delivery at near physiologic temperatures.
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