As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
LONDON – Moves to expand the legal remit of the European Medicines Agency (EMA) and give it more powers to deal with the COVID-19 pandemic and future health emergencies are moving to fruition, after the European Parliament and national health ministers in the European Council separately voted through the proposal.
While the amount of regulatory data in 2021 is up by 19% over last year, the 90 approvals by the U.S. FDA through late June is a decline of 17% over the same period in 2020, although the agency gave its blessing to the highest number of new molecular entities within the last several years.
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. bowed out of an opioid trial set for June 28 in New York by reaching a last-minute settlement with the state.
The FDA’s recent release of documents related to its accelerated approval of Aduhelm (aducanumab) did little to reduce the controversy surrounding that decision and the U.S. pricing of Biogen Inc.’s Alzheimer’s drug.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adial, Astellas, Aurinia, Biomarin, BMS, I-Mab, Incyte, Innocare, Jazz, Lynk, Mirati, Morphosys, Nicox, RDIF, Regeneron, Samsung, Y-Mabs.
PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
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