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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