Synthon Pharma`s Generic Gefitinib Receives Tentative Approval In US
NIJMEGEN, The Netherlands, August 25, 2020 / B3C newswire / -- Byondis B.V. (formerly Synthon Biopharmaceuticals B.V.) today announced that the first patients have started treatment in a Phase I study of its investigational antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985) in combination with niraparib in patients with a HER2-expressing locally advanced or metastatic solid tumor.
NIJMEGEN, The Netherlands--(BUSINESS WIRE)--Synthon Biopharmaceuticals B.V., a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless cancers and autoimmune diseases, today announced that it is relaunching as Byondis.
Fentanyl : Insys Therapeutics vs. Teva Pharmaceutical
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Synthon Biopharmaceuticals (Synthon) has announced that the US Food & Drug Administration (FDA) has granted Fast Track designation for its investigational anti-HER2 antibody-drug conjugate (ADC) [vic-] trastuzumab duocarmazine (SYD985). This designation is for treating patients diagnosed with HER2-positive metastatic breast cancer (MBC) that has progressed during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease, or progressed during or after [ado-]trastuzumab emtansine treatment.
European regulators have approved a generic 40mg version of Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone (glatiramer acetate).
Synthon announced that it has successfully concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe. Synthon’s three-times-a-week glatiramer acetate is a therapeutically equivalent version of the originator medicine Copaxone 40mg.
Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation.
Synthon BV says a Teva patent covering the active ingredient in Copaxone has been revoked by the European Patent Office’s technical board of appeal.