Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Inovio, Melt, Merck, Novartis, Regulus, Relief, Ridgeback, Roche, Scynexis, Teva.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apogenix, Black Diamond, Chi-Med, Foresee, Hemoshear, Larimar, Momenta, Nabriva, Protara, Realta.
“Nothing to see here” seems to be the general reaction to the four executive orders President Donald Trump signed Friday in an effort to reduce U.S. prescription drug prices. Two of the orders – one on importing drugs from Canada and the other on kicking the safe harbor out from under the rebates pharmacy benefit managers (PBMs) get from drug companies – instruct Health and Human Services (HHS) to continue, or resume, rulemaking on those measures.
The FDA approved Kite Pharma Inc.’s Tecartus (brexucabtagene autoleucel, KTE-X19), the first cell-based gene therapy for adults with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.
DUBLIN – Although Europe has moved first to approve Blenrep (belantamab mafodotin), Glaxosmithkline plc’s antibody-drug conjugate (ADC) as a fifth-line therapy in relapsed or refractory multiple myeloma, U.S. patients may well be first to gain access to the new drug.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Astrazeneca, Biomarin, Blueprint, Galapagos, Gilead, Heron, Insmed, Kyowa Kirin, Miragen, Myokardia, Novartis, Oncoceutics, Sarepta, Vistagen.
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