Algernon seeks ethics approval for Covid-19 trials in Australia
Clinical stage pharmaceutical development firm Algernon Pharmaceuticals is seeking ethics approval in Australia for its planned multinational Phase IIb/III study of its re-purposed drug Ifenprodil (NP-120) to treat coronavirus (Covid-19) patients.
Vraylar (cariprazine) for the Treatment of Bipolar Disorder and Schizophrenia
Vraylar (cariprazine) is a once-daily, oral, atypical antipsychotic drug indicated for the treatment of adults with bipolar I disorder and schizophrenia.
Zhittya gets regulatory approval in Mexico for trial of drug in PD patients
Zhittya Genesis Medicine has secured regulatory approval from Mexico's governing body COFEPRIS to test its drug in people with Parkinson's disease (PD).
Synthetic peptide drugs less likely to be approved than recombinant peptide drugs
GlobalData’s Likelihood of Approval (LoA) tool in the Drugs database considers the case for pipeline recombinant peptide drugs.
Givlaari™ (givosiran) for the Treatment of Acute Hepatic Porphyria
Givlaari™ (givosiran) is the first aminolevulinic acid synthase 1 (ALAS1)-targeting RNAi drug indicated for the treatment of acute hepatic porphyria (AHP) in adults.
Abeona to initiate Phase III trial of EB-101 to treat RDEB
Abeona Therapeutics is ready to initiate its pivotal Phase III clinical trial, VIITAL, to evaluate EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).
VUMERITY (diroximel fumarate) for the Treatment of Multiple Sclerosis
VUMERITY™ (diroximel fumarate), previously known as ALKS 8700, is a novel oral formulation indicated for the treatment of relapsing forms of multiple sclerosis (MS).