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AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi

Aug 23, 2019
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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Roxadustat approved in China for the treatment of anaemia in non-dialysis-dependent patients with…

Aug 23, 2019
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 Signs Ophthalmology Option Agreement

Aug 22, 2019
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 Granted FDA Breakthrough Device Designation for the PiCSO Impulse System

Aug 22, 2019
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 and Cara Therapeutics Enter into Licensing Agreement for Peptelligence to Advance…

Aug 22, 2019
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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Four Key Reasons to Attend the 2019 Biosimilars Conference

Aug 22, 2019
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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FDA Grants XTANDI (enzalutamide) Application Priority Review for the Treatment of Men with…

Aug 22, 2019
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 Invests Half Billion Dollars to Advance State-of-the-Art Gene Therapy Facility in Sanford,…

Aug 22, 2019
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 Enters a Licensing Agreement with Lilly to Develop & Commercialize a Novel Diabetes…

Aug 21, 2019
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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Enable Injections Enters into Strategic Partnership with Genentech

Aug 21, 2019
Enable Injections, Inc. (Enable), a company developing and manufacturing investigational wearable infusion devices for combination products, announced it has entered into a development…
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Industry Reports

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Press Releases

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