Opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in...
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).
Secuado (asenapine) for the Treatment of Schizophrenia
Secuado® (asenapine) is an atypical anti-psychotic drug approved for the treatment of schizophrenia in adult patients. It is the first drug approved as transdermal patch formulation for schizophrenia treatment in the US.
Vyvanse® (lisdexamfetamine) for the Treatment of Binge-Eating Disorder
Vyvanse® (lisdexamfetamine dimesylate) is a central nervous system (CNS) stimulant indicated for the treatment of moderate-to-severe binge-eating disorder and attention deficit hyperactivity disorder (ADHD).
FDA accepts Lilly’s protocol of pain trial for CID initiative
The US Food and Drug Administration (FDA) has accepted Eli Lilly’s pain clinical trial for the Complex Innovative Trial Designs (CID) Pilot Meeting Program.
TrialScope seeks to expedite clinical trials approval process with new UI
TrialScope has released a new version of its TrialScope Disclose platform to accelerate the review and approval process for clinical trial disclosure.
August’s top news stories
Biopharmaceutical firm Retrophin reported that the Phase III clinical trial of fosmetpantotenate failed to meet endpoints in pantothenate kinase-associated neurodegeneration (PKAN) patients; and MyoKardia has commenced dosing of patients in a Phase I trial of small molecule MYK-224 for the treatment of hypertrophic cardiomyopathy (HCM). Clinicaltrialsarena.com wraps up the key headlines from August 2019.
Opdivo (Nivolumab) for the Treatment of Unresectable or Metastatic Melanoma
Opdivo (nivolumab) is indicated for the treatment of unresectable or metastatic melanoma in patients with a positive BRAF V600 mutation who were previously treated and made progression with Yervoy (ipilimumab).