India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges.

A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.

After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.

The med-tech industry across Latin America continues to grow, but the growth is uneven, concentrated in a handful of countries and faces significant challenges. A report released in December by the United Nations Economic Commission for Latin America and the Caribbean (ECLAC) reveals the complexity of the region's med-tech trade balance and underscores the main challenges for the industry in the region, whose performance was also impacted by the COVID-19 pandemic.

Glaciers are known to move slowly, but so is government, and the FDA needed seven years to make effective an order that cerebrospinal fluid shunts be deemed class II devices. The classification was applicable as of Aug. 22, 2014, in connection with a de novo petition filed by no less than industry colossus Medtronic plc, of Dublin, in a process that began in 2012, possibly earlier.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has undertaken a massive effort to reform its drug and device regulations, and as it pulls into the homestretch with those reforms, it is setting its sights to postmarketing efforts that include adverse event reporting, conformity assessments, patient-reported outcomes and a universal device identifier program.

Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.