Two decades after launching clinical trials, Kyowa Hakko Kirin finally received FDA approval for add-on Parkinson’s therapy https://endpts.com/decades-into-the-making-kyowa-hakko-kirin-wins-fda-approval-for-add-on-parkinsons-therapy/?utm
Mylan won tentative US approval for generic version of Lilly’s Alimta, but it could be years before it can be sold. https://endpts.com/mylan-wins-tentative-us-approval-for-generic-version-of-lillys-alimta-but-it-could-be-years-before-its-sold/
CARsgen Therapeutics Inc. announced the FDA has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma. https://www.prnewswire.com/news-releases/carsgen-therapeutics-receives-us-fda-orphan-drug-designation-for-fully-human-anti-bcma-b-cell-maturation-antigen-autologous-chimeric-antigen-receptor-car-t-cells-for-the-treatment-of-multiple-myeloma-300910042.html
GeneTx Biotherapeutics and Ultragenyx Pharmaceuticals announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GTX-102 for the treatment of Angelman Syndrome. http://www.firstwordpharma.com/node/1663578#axzz5yYpVzctk
Puma Biotechnology announced that the FDA has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases. http://www.firstwordpharma.com/node/1663665#axzz5yYpVzctk
Emalex Biosciences announced that it has received Fast Track designation for its investigational product, ecopipam, from the FDA for the treatment of patients with Tourette Syndrome (TS). https://www.drugs.com/clinical_trials/emalex-biosciences-receives-fda-fast-track-designation-ecopipam-patients-tourette-syndrome-18251.html
Ra Pharmaceuticals announced that the FDA granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis. http://www.firstwordpharma.com/node/1663855#axzz5yer9Drup
BioXcel Therapeutics announced that the FDA has granted Orphan Drug Designation for BXCL701, an investigational orally-available systemic innate immunity activator with dual mechanisms of action, for the treatment of Acute Myeloid Leukemia (“AML”). http://www.firstwordpharma.com/node/1663856#axzz5yer9Drup
In other news…
Vertex is paying $950 million for stem cell diabetes player Semma Therapeutics https://www.fiercebiotech.com/biotech/vertex-plunks-down-950m-for-stem-cell-player-semma-therapeutics
Mallinckrodt is preparing for a possible bankruptcy amid a maelstrom of opioid claims. https://endpts.com/mallinckrodt-preps-a-possible-bankruptcy-amid-a-maelstrom-of-opioid-claims-report/
Roivant’s Vivek Ramaswamy is closing in on a $3B cash deal to sell control of five Vant companies to Sumitomo Dainippon https://endpts.com/vivek-ramaswamy-is-closing-in-on-a-3b-cash-deal-to-sell-control-of-5-vants-plus-to-sumitomo-dainippon/
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