Clinical Intelligence

Amgen’s phase III migraine drug success

Friday, September 30, 2016

Amgen has announced positive top-line results for erenumab (AMG 334) from A phase III, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention (ARISE). These data showed the ARISE study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab compared with placebo at 12 weeks. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of migraine.

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Zafgen initiates phase I trial of ZGN-1061

Wednesday, September 21, 2016

Zafgen, a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has announced that the company has recently initiated dosing in the multiple ascending dose (MAD) cohorts of its ongoing phase I clinical trial of ZGN-1061. The initiation of the MAD portion was triggered following a review of the initial safety and tolerability data from the first two cohorts of the single ascending dose (SAD) portion of the clinical trial. ZGN-1061 is a second-generation, differentiated MetAP2 inhibitor in development for severe and complicated obesity indications.  

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Janssen completes WHO submission for EUAL for Ebola vaccine regimen

Wednesday, September 14, 2016

Bavarian Nordic has announced that Janssen Vaccines & Prevention has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic’s MVA-BN Filo vaccine. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.

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GenSight to add teenage patients in Leber’s hereditary optic neuropathy trial

Tuesday, September 13, 2016

GenSight Biologics, a biopharma company that discovers and develops innovative gene therapies for neurodegenerative retinal diseases and diseases of the central nervous system, has announced that regulatory agencies and ethics committees in the U.S., France and the U.K., have authorized a protocol amendment to include teenage patients (15-18 years) in RESCUE and REVERSE, two ongoing phase III clinical trials of GS010 in the treatment of Leber’s Hereditary Optic Neuropathy (LHON).

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