Pharma Journalist -

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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