Alkermes initiates ALKS 5461 NDA for major depressive disorder

Tuesday, August 22, 2017

Alkermes announced the initiation of its rolling submission of a New Drug Application (NDA) to the FDA, seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action, for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission of the NDA for this Fast Track designated medicine by year-end 2017.

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Fastest drug developers and their practices

Tuesday, August 1, 2017

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. A new CenterWatch analysis of new molecular entities (NMEs) approved by the FDA from 2014 through 2016 shows no signs of dramatic, industry-wide improvement. Sponsors interviewed by CenterWatch cited multiple factors that influence the speed of their development programs. In particular, the selection of investigative sites and vendors (including CROs), and the relationships forged with them, were an important focus of companies seeking to improve the speed and efficiency of clinical trials.

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FDA approves Alkermes ARISTADA treatment for schizophrenia

Wednesday, June 7, 2017

Alkermes announced that the FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is now FDA-approved in four doses and three dosing duration options (441mg, 662mg or 882mg once monthly, 882mg once every six weeks and 1064mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

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Alkermes initiates phase III study of ALKS 8700 for multiple sclerosis

Thursday, March 16, 2017

Alkermes has announced the initiation of a new phase III study of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in development for the treatment of relapsing forms of multiple sclerosis (MS). ALKS 8700 is designed to rapidly and efficiently convert to MMF in the body and offer differentiated features as compared to the currently marketed dimethyl fumarate, TECFIDERA. The five-week, head-to-head study will evaluate the gastrointestinal (GI) tolerability of ALKS 8700 compared to TECFIDERA in approximately 420 patients with relapsing-remitting MS (RRMS). This elective study is part of the ongoing clinical development program for ALKS 8700, named EVOLVE-MS (Endeavoring to Advance Treatment for Patients Living with Multiple Sclerosis). The company plans to submit a New Drug Application (NDA) for ALKS 8700 for the treatment of RRMS to the FDA in 2018.

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Alkermes has positive phase III results for ALKS 5461 in major depressive disorder

Monday, January 25, 2016

Alkermes has announced preliminary topline results from FORWARD-3 and FORWARD-4, the first two of three phase III efficacy studies to read out from the comprehensive FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS).

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Ruthigen, Pulmatrix ink merger agreement

Monday, March 16, 2015

Ruthigen, a biopharmaceutical company based in Santa Rosa, Calif., and Pulmatrix, a Lexington, Mass.-based clinical stage biotech, have entered into a definitive merger agreement. Pulmatrix will become a wholly-owned subsidiary of Ruthigen and all of Pulmatrix’s debt and equity securities outstanding prior to the consummation of the merger will be exchanged for shares of Ruthigen common stock that will represent approximately 81% of the outstanding common stock of Ruthigen.

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TrialNetworks appoints Jorge G. Guerra advisory board chairman

Monday, January 20, 2014

Jorge G. Guerra, M.D., has joined TrialNetworks as chairman of the advisory board. The TrialNetworks platform, which began as an innovative site engagement and communication portal, has rapidly grown into a comprehensive cloud-based solution for key aspects of a clinical trial from startup through closeout, including feasibility surveys, training, trial conduct efficiency, patient recruitment and retention, site activation and document management.

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