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Acorda Resubmits New Drug Application for INBRIJA (CVT-301, levodopa inhalation powder)

Dec 7, 2017
Acorda Therapeutics announced the resubmission of its New Drug Application (NDA) for INBRIJA to the U.S. Food and Drug Administration (FDA). INBRIJA is an investigational treatment for…
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Neon Therapeutics Announces Clinical Trial Collaboration with Merck

Dec 7, 2017
Neon Therapeutics announced that it has entered a clinical trial collaboration with Merck (known as MSD outside the United States and Canada) to evaluate Neon Therapeutics’ proprietary…
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Concentric Analgesics Receives FDA Fast Track Designation for CA-008 for Post-Surgical Pain

Dec 7, 2017
Concentric Analgesics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CA-008 for the treatment of post-surgical pain. CA-008 is a…
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Carmot enters a Multi-Year Drug Discovery Collaboration with Amgen

Dec 7, 2017
Carmot Therapeutics, announced that it has entered into a multi-year drug discovery collaboration and licensing agreement with Amgen (Thousand Oaks, CA). As part of the agreement,…
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Advanced Clinical expands operations in Europe with two new offices

Dec 7, 2017
Advanced Clinical, a clinical development organization providing CRO, FSP, Quality & Validation, and Strategic Resourcing services, announced the opening of its new offices in…
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FDA grants Genentech’s Avastin full approval for most aggressive form of Brain Cancer

Dec 6, 2017
Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin (bevacizumab) for the treatment of adults with…
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Pfizer to develop and commercialize CRESEMBA in China and Asia Pacific region

Dec 6, 2017
Pfizer and Basilea Pharmaceutica announced that they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and…
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First Patient Enrolled in Phase 3 Trial for ATIR101 in Adult Patients with Blood Cancer

Dec 6, 2017
Kiadis Pharma announces that the first patient has been enrolled in the HATCY Phase 3 clinical trial for ATIR101. The multinational trial will evaluate the safety and efficacy of…
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Mylan and Aspen announce Launch of Generic Busulfex Injection

Dec 6, 2017
Mylan N.V. and its partner, Aspen, announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's…
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Sunovion receives FDA approval for Lonhala Magnair Inhalation Solution to Treat COPD

Dec 6, 2017
Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution…
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