In the latest skirmish over who can get the 340B discounts on prescription drugs that are supposed to help qualifying U.S. providers offer charity care, the Pharmaceutical Research and Manufacturers of America (PhRMA) is challenging a recently passed Arkansas law that seeks to regulate drug manufacturers’ participation in the federal drug pricing program.
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane.
A cloud-based web application for long-term brain monitoring has received a CE mark to support personalized management of neuro-disorders such as epilepsy. Developed by Swiss neuroscience research organization Wyss Center, Epios Cloud displays and reviews electroencephalogram (EEG) recordings made by EEG devices using scalp and sub-scalp electrodes, heart rate and accelerometer measurements.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Haemonetics, Siemens.
Merck & Co. Inc. and Ridgeback Biotherapeutics Inc. are planning a U.S. emergency filing for potentially the first oral antiviral for COVID-19, after a phase III trial showed molnupiravir cut risk of hospitalization or death by around 50%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Alzinova, Basilea, Bexion, Cantargia, Diamedica, Glenmark, Immix, Jubilant, Liscure, Mirum, Pfizer, Reata, Selecta, TG.
The FDA’s 2019 approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi to treat children ages 6 to 17 with Lambert-Eaton myasthenic syndrome must be set aside because it violated the Orphan Drug Act in light of Catalyst Pharmaceuticals Inc.’s seven-year orphan exclusivity for its LEMS drug, Firdapse, the U.S. Court of Appeals for the 11th Circuit ruled Sept. 30.
As if it were needed, Amicus Therapeutics Inc.’s spin-off of its gene therapy work and PDUFA VII’s provisions to increase the capacity of the FDA’s Center for Biologics Evaluation and Research offered further proof this week of the global explosion that’s happening in the regenerative medicine field.
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