Clinical Intelligence

Sunovion receives NDA Acceptance for COPD treatment SUN-101/eFlow

Thursday, October 13, 2016

Sunovion Pharmaceuticals has announced that the FDA has accepted for review the New Drug Application (NDA) for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.

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FDA approves Carnexiv (carbamazepine) injection for seizures

Wednesday, October 12, 2016

Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

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Teva, Celltrion partner on biosimilar commercialization

Thursday, October 6, 2016

Teva Pharmaceutical Industries, Celltrion and Celltrion Healthcare have entered into an exclusive partnership to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada. CT-P10 is a proposed mAb biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), Wegener’s granulomatosis and microscopic polyangiitis (MPA).

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Alnylam Pharmaceuticals discontinues revusiran development

Thursday, October 6, 2016

Alnylam Pharmaceuticals, an RNAi therapeutics company, announced that upon the recommendation of the ENDEAVOUR phase III study Data Monitoring Committee (DMC) to suspend dosing, the company has decided to discontinue development of revusiran, an investigational RNA interference (RNAi) therapeutic that was being developed for the treatment of hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM). This decision was made yesterday evening and has been communicated to investigators, study sites, and regulatory authorities.

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AbbVie’s HCV regimen receives FDA Breakthrough Therapy designation

Tuesday, October 4, 2016

The FDA has granted Breakthrough Therapy Designation (BTD) for AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.

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The CenterWatch Weekly, October 03, 2016

Monday, October 3, 2016

CHOP launches pediatric genetic care initiative

A $50 million genetics care initiative was recently implemented by the Children’s Hospital of Philadelphia (CHOP) for the research of genetic diagnostics and clinical disease management in pediatric care. Termed the Roberts Collaborative for Genetics and Individualized Medicine, this initiative is largely funded by the Roberts family, the founders of Philadelphia-based Comcast, with a sizable donation contributing toward the integration of genetic research and education in all of CHOP’s clinical departments and centers.

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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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