News

Mylan N.V. and its partner, Aspen, announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial, a generic version of Otsuka Pharmaceutical's…
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Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Lonhala Magnair (glycopyrrolate) Inhalation Solution…
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Yesterday marked dosing of the first patient with type 1 diabetes in a feasibility study to evaluate the functionality and safety of an automated insulin delivery (AID) system in…
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Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and…
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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 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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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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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 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 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 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 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 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 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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Brammer Bio announced the completion of renovations and launch of its late-stage clinical capacity and commercial-ready cGMP manufacturing site in Cambridge, Massachusetts for gene…
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Recipharm has equipped three more of its facilities with serialisation capabilities in line with the US regulatory requirements in time for today’s introduction of the Drug Supply Chain…
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Catalyst Pharmaceuticals announced positive top-line results from a second Phase 3 clinical trial (LMS-003) of Firdapse® (amifampridine phosphate tablets equivalent to 10 mg…
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Stealth BioTherapeutics (Stealth) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead candidate, elamipretide, for the treatment…
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Lead Pharma announced that it has achieved a third milestone under its research collaboration with Sanofi, triggering an undisclosed milestone payment. The collaboration aims to develop…
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Beactica, the Swedish drug discovery company, announced that it has been awarded 2 MSEK (~$240 000) by the Swedish Governmental Agency for Innovation Systems (Vinnova) to advance its…
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