Salix and Progenics Announce FDA Advisory Committee to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain

Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) today announced that the FDA is seeking input from an Advisory Committee on Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain. 

 The FDA's action to convene an Advisory Committee was taken in response to the formal appeal by Salix of the complete response action taken by the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain. The FDA has said that it will take action under the appeal after receiving input from the Advisory Committee. The FDA will notify the Company once the Advisory Committee meeting date has been determined. 

Published: 11 June 2013
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ImmunoCellular Therapeutics Announces Recommendation of Data Monitoring Committee to Continue ICT-107 Phase II Trial Following Interim Analysis

Study Completion Anticipated by Year-End 2013

ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced that the Data Monitoring Committee (DMC) has completed a pre-specified interim analysis of the ICT-107 phase II clinical trial in patients with newly diagnosed glioblastoma and recommended that the company continue the trial to completion.

The trial design for the ICT-107 study provides for the interim analysis to be conducted by the independent DMC after 32 events (patient deaths) are reached.

Published: 07 June 2013
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Medicago is First in the World to Report Positive Interim Results for its H7N9 Pre-Clinical Trial

- The H7 VLP vaccine candidate induces an antibody response after a single dose in mice-

Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a preclinical trial for an H7N9 Avian Influenza VLP vaccine candidate ("H7 vaccine"). The data show that three micrograms of the H7 vaccine administered with and without adjuvant induced high antibody titers after one dose.

Published: 06 June 2013
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TESARO, Breast International Group (BIG), and the European Organization for Research and Treatment of Cancer (EORTC) Announce Collaboration for Niraparib Clinical Development in Breast Cancer

TESARO, Inc. (TSRO), an oncology-focused biopharmaceutical company, Breast International Group (BIG), a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment of Cancer (EORTC), an international, independent, multidisciplinary non-profit research organization, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor.

Published: 03 June 2013
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Omthera Pharmaceuticals Announces First Quarter 2013 Financial Results

Omthera Pharmaceuticals, Inc. (OMTH), an emerging specialty pharmaceutical company, today announced its financial results for the first quarter of 2013.

Omthera Pharmaceuticals also announced today that it had entered into a definitive merger agreement with AstraZeneca pursuant to which AstraZeneca will acquire Omthera for $12.70 per share, or approximately $323 million. In addition to the cash payment, each Omthera stockholder will receive one Contingent Value Right (CVR) of up to approximately $4.70 for each share they own, equating to $120 million, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. This will bring the total potential acquisition value to $443 million.

Published: 28 May 2013
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