The EMA issued a guidance Feb. 25 outlining the requirements for manufacturers planning to modify COVID-19 vaccines to address emerging variants of the SARS-CoV-2 coronavirus.
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
As expected, the FDA granted an approval for Amondys 45 (casimersen), a new Duchenne muscular dystrophy (DMD) therapy developed by Sarepta Therapeutics Inc.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aquestive, Bluebird, Cansino, Exelixis, Gannex, J&J, Retrotope, RDIF, Sinopharm, Viiv.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Antengene, Kura, Pfizer, RDIF, Teleflex.
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
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