Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognoa, Edwards, Sorrento.
Novartis AG is closing in on a label expansion for its blockbuster inflammatory disease drug, Cosentyx (secukinumab), after announcing supportive phase III results in children with two subtypes of juvenile idiopathic arthritis (JIA).
Borrowing a chapter from venture capitalists, the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit Global Health Investment Corp. (GHIC) to accelerate the development and commercialization of medical technologies and products needed to respond to or prevent future pandemics and other public health emergencies.
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, BMS, Boehringer, Inmune, Janssen, Kamada, Karyopharm, Kedrion, Novartis, RDIF, Roche, Scynexis, Sinovac, Soleno, Stealth, Tetra, Zealand.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
Acting FDA commissioner Janet Woodcock appeared at the annual forum held by the Medical Device Innovation Consortium (MDIC) and noted that real-world evidence (RWE) has tremendous potential in regulatory decision making. However, she cautioned that while “the future is very bright” for RWE, “it’s going to take longer than some of the enthusiasts might have thought” to maximize this source of data in product reviews.
Drug regulators throughout China cracked down last year on companies manufacturing and selling counterfeit and substandard drugs and active pharmaceutical ingredients.