Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
The FDA has put a hold on a clinical study of a rare disease gene therapy BMN-307 from Biomarin Pharmaceutical Inc. after several mice developed liver tumors following a high dose in a preclinical trial.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arctic Vision, Astrazeneca, Impel, Neuren, Oncopeptides, Pharmabcine, Supernus.
The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. The approval comes as several competitors, including Axsome Therapeutics Inc and Abbvie Inc., have NDAs submitted or approved for new therapies to treat migraine.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cstone, Eqrx, Evgen, Kahr, Moderna, Novartis, Orphalan, Pfizer, Polaryx, Relief, TCR2, Tetra.
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
In a precedential opinion, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s conclusion that Belcher Pharmaceuticals LLC’s chief science officer engaged in inequitable conduct by withholding material information from the U.S. Patent and Trademark Office during prosecution of Belcher’s 9,283,197 patent.
Now that the U.S. judge overseeing Purdue Pharma LP’s bankruptcy proceedings has conditionally signed off on a $10 billion settlement intended to resolve 3,000 opioid lawsuits filed by states, tribes and local governments, the privately owned drugmaker can take the first steps to transform itself into a public service company owned mostly by the National Opioid Abatement Trust and governed by a new independent board.
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