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March 16, 2011
MorphoSys AG and Boehringer Ingelheim have signed a manufacturing agreement for therapeutic antibodies covering the process development and manufacture of additional clinical material for MorphoSys’s MOR208 program and other drug candidates.
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March 16, 2011
Akrimax Pharmaceuticals has introduced NitroMist (Nitroglycerin Lingual Aerosol) 400mcg/spray indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
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March 16, 2011
Almac has invested in two ZED automated inline wallet presses at its Craigavon and Pennsylvania facilities.
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March 16, 2011
RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold.
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March 15, 2011
Cytovance Biologics has secured financing of $22.5 million from Great Point Partners, LLC to invest in the expansion its biologic manufacturing capabilities in Oklahoma City.
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March 15, 2011
KINAXO Biotechnologies GmbH has entered a second collaboration with Takeda Pharmaceutical Co., under which KINAXO will apply its PhosphoScout technology to assist research of Takeda’s drugs under development.
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March 15, 2011
Incyte Corporation’s COMFORT-II, the second Phase III trial of investigational Janus kinase (JAK) inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis.
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March 15, 2011
Dr. Stuart Grant has been promoted to associate director of regulatory affairs and medical writing at ClinTec International.
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March 14, 2011
Elanco, Lilly’s animal health division, has made a one-time offer to acquire the animal health business of Janssen Pharmaceutica NV, a Johnson & Johnson company.
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March 14, 2011
PROLOR Biotech, Inc. is relocating its corporate office and R&D facility to a new, larger building located near its current site in the Weizmann Science Park in Nes Ziona, Israel.
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March 14, 2011
Lance Miyamoto has been appointed senior vice president of Human Resources, Catalent Pharma Solutions, Inc.
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March 14, 2011
Mark D’Souza has been appointed president and chief executive officer of Labopharm and a member of the board of directors.
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March 11, 2011
McNeil-PPC, Inc., a Johnson & Johnson subsidiary, has finalized the terms of a Consent Decree with the FDA.
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March 11, 2011
Dendreon Corp. received approval from the FDA for the expansion of its NJ manufacturing facility, allowing the company to significantly increase the availability of Provenge.
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March 11, 2011
Tolerx and GlaxoSmithKline’s Phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint in patients with new-onset autoimmune type 1 diabetes.
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