Issue link: https://www.e-digitaleditions.com/i/1233462
Tablets & Capsules April 2020 9 therapies including lenalidomide and a proteasome inhibitor. Blockchain technology can meet DSCSA requirements S A N F R A N C I S C O , C A — A blockchain-based drug product tracking network can help compa- nies meet Drug Supply Chain Secu- rity Act (DSCSA) requirements by 2023, according to report released by the MediLedger Pilot Project. The FDA's DSCSA pilot project pro- the pharmaceutical manufacturer's six European API production sites located in Italy, Germany, France, Hungary, and the UK. The new API company will be the second largest in the world and is to be headquartered in France and have 3,100 employees. In other news, the FDA approved Sanofi's Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone to treat adults with relapsed refractory multiple myeloma who have received at least two prior ferences have been rescheduled: CPhI South East Asia (July 1-6), CPhI Japan (September 30-October 2), Parenteral Drug Association Annual Meeting (July 20-22), Phar-East (June 30-July 1), Analytica (October 19-22), Phar- maconex (TBD), Interphex (July 15-17), CPhI North America (Sep- tember 9-11), Interpack (February 25-March 3, 2021), The Regulatory Affairs Professional Society Euro Con- vergence (TBD), LogiPharma (Sep- tember 1-3), and Formulation and Delivery Series UK (July 8-9). FDA publishes 43 product- specific guidances S I L V E R S P R I N G , M D — T h e FDA published 33 new and 10 revised product-specific guidances, which provide recommendations for developing generic drugs and gen- erating the evidence needed to sup- port Abbreviated New Drug Appli- cation (ANDA) approval. Of the 42 guidances, 38 are for products with no approved ANDAs. Guidances for generic products include treatments for ALS, diabetes, HIV, lung cancer, and melanoma. FDA approves Biohaven and Catalent ODT migraine treatment NEW HAVEN, CT—The FDA approved Nurtec (rimegepant) orally dissolving tablet (ODT) as an acute treatment for adults suffering from migraines. The product is owned by Biohaven Pharmaceuticals, which partnered with Catalent to create the migraine treatment. Using Catal- ent's Zydis ODT platform, the com- panies created a freeze-dried tab- let that disperses almost instantly in the mouth without water, allowing patients to treat their migraines in a convenient and discreet manner. The ODT is Biohaven's first FDA-ap- proved product and is currently the first and only calcitonin gene-related peptide receptor antagonist available in a fast-acting ODT. Sanofi establishes API company, receives FDA approval for Sarclisa BRIDGEWATER, NJ—Sanofi plans to create an API manufactur- ing company that would combine