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FDA Grants Priority Review for a sNDA for XTANDI (enzalutamide) in Non-Metastatic CRPC

Mar 21, 2018
Pfizer and Astellas Pharma announced that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by…
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Ionis and Akcea Partner to Commercialize Inotersen for hATTR

Mar 21, 2018
Ionis Pharmaceuticals and Akcea Therapeutics, Inc., an affiliate of Ionis, announced an exclusive, worldwide license by Ionis to Akcea for inotersen and AKCEA-TTR-LRx, formerly…
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Lundbeck to acquire Prexton Therapeutics

Mar 21, 2018
H. Lundbeck A/S (Lundbeck) and Prexton Therapeutics BV (Prexton) announced signing of a definitive agreement in which Lundbeck will acquire Prexton. Under terms of the agreement,…
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Intezyne Partners with Exosome Diagnostics on IT-139 Companion Diagnostic

Mar 21, 2018
Intezyne announced that it has partnered with Exosome Diagnostics, a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics, to design…
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Mallinckrodt Completes Sale Of RECOTHROM And PREVELEAK To Baxter

Mar 21, 2018
Mallinckrodt plc announced it has closed the sale of RECOTHROM Thrombin topical (Recombinant) and PREVELEAK Surgical Sealant to Baxter International Inc. "This action further…
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Ardelyx and Knight Collaborate to Bring Tenapanor to Patients in Canada

Mar 21, 2018
Ardelyx, Inc. announced a license agreement with Knight Therapeutics, Inc. (Knight) that provides Knight with exclusive rights to commercialize tenapanor in Canada. Tenapanor is…
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Nexcelom Bioscience announces strategic growth investment from Ampersand Capital Partners

Mar 21, 2018
Nexcelom Bioscience announced that it has received a strategic investment from Ampersand Capital Partners. The funding will be primarily used to support Nexcelom's worldwide growth…
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Mylan Adds to Growing Oncology Portfolio with Launch of Generic Mutamycin Injection

Mar 21, 2018
Global pharmaceutical company Mylan N.V. announced the U.S. launch of the oncology drug Mitomycin for Injection USP, 5 mg/vial, 20 mg/vial and 40 mg/vial Single Dose Vials, a generic…
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MHRA Grants UK Patients Early Access to Akcea Therapeutics’ Volanesorsen for FCS

Mar 21, 2018
Akcea Therapeutics United Kingdom (UK) Ltd announced that volanesorsen has been granted a positive scientific opinion through the Early Access to Medicines Scheme (EAMS) by the UK’s…
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Kalytera Initiates Program to Develop a Novel Cannabinoid-Based Compound for Treatment of Acute and…

Mar 21, 2018
Kalytera Therapeutics announced that it has begun development of a novel cannabinoid-based compound for the treatment of acute and chronic pain. Patents for this compound have been…
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