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GSK submits US regulatory application for single-dose tafenoquine for P. vivax malaria

Nov 30, 2017
GSK and Medicines for Malaria Venture (MMV) announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of…
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Titan Pharmaceuticals Partners with Molteni to Market Probuphine in Europe

Nov 30, 2017
Titan Pharmaceuticals announced that it has entered into a binding term sheet with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., pursuant to which the parties…
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BIOCAD Launches the New Manufacturing Site in North Africa

Nov 30, 2017
Russian biotechnology company BIOCAD and Moroccan pharmaceutical company Sothema Labs announced the launch of medicines derived using the technology provided by the Russian manufacturer…
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FDA Renews and Expands Its Portfolio of Simcyp Simulator (PBPK) Licenses

Nov 29, 2017
Certara announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s PBPK Simcyp® Population-based Simulator and its Pediatric and Cardiac Safety…
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Sobi receives approval for Orfadin (nitisinone) Oral Suspension for the Treatment of HT-1

Nov 29, 2017
Sobi has received approval from Health Canada for an oral suspension formulation of Orfadin® (nitisinone). Orfadin is the first medicine approved in multiple countries globally for use…
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Biogen and Alkermes collaborates to develop and commercialize ALKS 8700

Nov 29, 2017
Biogen and Alkermes plc announced that they have entered into a global license and collaboration agreement to develop and commercialize ALKS 8700, a novel, oral, monomethyl fumarate…
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AstraZeneca submits sNDA for Tagrisso in 1st line EGFRm NSCLC in Japan

Nov 29, 2017
AstraZeneca announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso (osimertinib), a…
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Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate

Nov 29, 2017
Takeda Pharmaceutical announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately…
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Pharming submits application to FDA for RUCONEST to treat HAE

Nov 29, 2017
Pharming Group announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration for RUCONEST  for routine prophylaxis to…
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HITGEN & Boehringer enter DNA-Encoded Library Based Drug Discovery Research Collaboration

Nov 29, 2017
HitGen Ltd announced that the company has entered into a drug discovery research collaboration with Boehringer Ingelheim to identify novel small molecule leads for targets of interest…
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Industry Reports

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Press Releases

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