Alkermes

Pulmatrix appoints Robert Clarke as CEO

Thursday, September 6, 2012 08:28 AM

Pulmatrix, a Lexington, Mass.-based clinical stage biotechnology company, has promoted Robert Clarke, Ph.D., to the position of CEO and to the board of directors.

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FDA approves once-weekly treatment for type 2 diabetes

Monday, January 30, 2012 02:35 PM

The FDA has approved Bydureon (extended-release exenatide), the first once-weekly treatment for type 2 diabetes, developed by Amylin Pharmaceuticals and Alkermes.

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Alkermes initiates phase III ALKS 9070 study for schizophrenia

Monday, December 19, 2011 01:42 PM

Alkermes has initiated a phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.

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FDA reviews BYDUREON, type 2 diabetes medication

Friday, August 12, 2011 02:48 PM

Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

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Elan cuts 104 jobs

Friday, July 15, 2011 10:13 AM

Following the recent decision to sell its drug manufacturing unit to Alkermes for $960 million, Elan is eliminating 104 jobs from a Pennsylvania facility that is part of the deal, according to a notice filed with the Pennsylvania Department of Labor.

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Study results support BYDUREON’s NDA

Friday, July 8, 2011 12:21 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced results from QT (tQT) study of exenatide to increase the QT interval across a wide range of plasma concentrations. The study was conducted to satisfy a requirement by the FDA in support of the New Drug Application (NDA) for BYDUREON (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

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Diabetes phase II study shows positive results

Monday, March 14, 2011 01:50 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced positive results from a phase II study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type II diabetes.

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