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GlaxoSmithKline plc announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral…
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AstraZeneca announced that it has agreed to buy a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) for a total cash consideration of $95m from a subsidiary of Swedish…
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AstraZeneca announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the…
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Iconic Therapeutics, a private biopharmaceutical company focused on novel therapeutics for serious diseases such as cancer and age-related macular degeneration (AMD), announced that the…
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Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO Impulse System for treatment of STEMI…
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Enteris BioPharma announced its entry into a definitive licensing agreement with Cara Therapeutics (Nasdaq: CARA) for Enteris' Peptelligence technology in the ongoing development of an…
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SMi Reports: Conference chair, Michel Mikhail, gives four key reasons to attend the Biosimilars conference this September The 10th Annual Biosimilars conference is set to take place…
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TOKYO & Astellas Pharma Inc. and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application…
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Pfizer announced an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility…
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Innovent Biologics, Inc. (Innovent) announced that it has entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of…
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