Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ortho Regenerative Technologies, Pharmaessentia USA, Pharming Group, Regeneron, Visen.
Preparing for the full implementation of the 2013 Drug Supply Chain Security Act (DSCSA), the FDA finalized two guidances June 3 and released two draft guidances to help supply chain partners comply with the law’s requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
The U.S. Federal Trade Commission (FTC) is turning the biopharma industry’s claim about rebates on its ear, saying some rebates paid to pharmacy benefit managers and third-party payers are an anticompetitive tool drug companies use to maintain their U.S. market power.
Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch, Can-Fite, Celltrion, Clearside, Dermavant, Eli Lilly, Iaso, Innovent, Micurx, Protagonist, Roivant.
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.
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