PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Attana, Front Line Medical, Galderma, Neuros Medical.
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.
Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.
The FDA has posted an update on its surveillance of adverse events for bronchoscopes, noting that the number of medical device reports (MDR) has risen to between 100 and 200 such reports per year in the U.S. However, the agency noted that there are half a million procedures performed with these devices each year in the U.S. alone, and that these data are insufficient to infer a specific incidence of adverse events.
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