At its October meeting, the EMA’s Committee for Human Medicinal Products (CHMP) voted in favor of 11 new therapies, two of them for treating cancers and two for treating HIV-1. The European Commission will review the recommendations and make its decisions by the end of 2020.
Once upon a time in an age before the Internet, all things digital and even Hatch-Waxman, the FDA worked in its corner of the government approving drugs and therapeutic equivalents with little fanfare or transparency. Its decisions were duly recorded on paper and filed away. With the files located only at the agency, pharmacies across the country were left to wonder about which drugs could be substituted for another. Their recourse was to pick up the phone and pay for a long-distance call to the FDA every time a question arose. To reduce the number of phone calls it was getting, the FDA printed out a list of approved drugs with their equivalents and sent it to the pharmacies. The year was 1980, and the month was October. Going with the season, the FDA slapped an orange paper cover on the listing, giving birth to the Orange Book.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livmor, Sanuwave, See-Mode Technologies.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
In Regeneron Pharmaceuticals Inc.’s Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), the FDA has approved its first ever treatment for the Ebola virus in pediatric and adult patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, Armata, Eton, Merck, Immunitybio, OS, Regeneron, Zhittya.
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