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Alkermes Receives Refusal to File Letter From FDA for ALKS 5461

Apr 4, 2018
Alkermes plc announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461, a once-daily,…
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FDA accepts BLA for moxetumomab pasudotox in hairy cell leukaemia

Apr 4, 2018
AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational…
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Compugen Announces License Agreement With MedImmune for antibody products

Apr 4, 2018
Compugen Ltd. announced it entered into an exclusive license agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to enable the development of…
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Q-State Biosciences and Vertex Pharma Enter into Multi-Year Drug Discovery Collaboration

Apr 4, 2018
Q-State Biosciences announced that the company has entered into a strategic collaboration with Vertex Pharmaceuticals Incorporated to discover drugs using Q-State’s novel Optopatch…
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Hear From Boehringer-Ingelheim and Janssen at SMi’s 6th annual conference Pharmaceutical Freeze…

Apr 4, 2018
SMi Group are delighted to announce the 6th annual Pharmaceutical Freeze Drying Technology conference, being held this June 2018! Read on for a massive £400 off. Optimizing…
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Puma and Pint Pharma to Commercialize NERLYNX (neratinib) in Latin America

Apr 3, 2018
Puma Biotechnology and Pint Pharma International have entered into an agreement for Pint Pharma to commercialize NERLYNX (neratinib) in Argentina, Brazil, Chile, Colombia, Mexico and…
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SpinalCyte Announces MRI Evidence of Disc Regeneration Following Phase 1/Phase 2 Clinical Trial of…

Apr 3, 2018
MRI analysis of patients who received intradiscal injections of human dermal fibroblasts (HDFs) shows significant improvement in disc height after six months. This is the latest…
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PharmaCyte Ships Clinical Trial Cells to Austrianova for Encapsulation

Apr 2, 2018
PharmaCyte Biotech, Inc. announced that vials of cells from PharmaCyte’s Master Cell Bank (MCB) have been shipped by Eurofins Lancaster Laboratories (Eurofins) to Austrianova’s…
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Dr. Reddy’s Laboratories and Promius Pharma announce the filing of an NDA for its migraine…

Apr 2, 2018
Dr. Reddy’s Laboratories Ltd and its subsidiary, Promius Pharma, LLC announced the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the U.S. Food and Drug…
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Synlogic Doses First Patient in Phase 1b/2a Trial of SYNB1020 for Treatment of Hyperammonemia in…

Apr 2, 2018
Synlogic announced that the first patient was dosed in its Phase 1b/2a clinical trial of SYNB1020. SYNB1020 is a Synthetic Biotic medicine being developed for the treatment of…
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