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kyra smith

Contract Medical Writer - 0 views

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    Medical writing is the process of writing scientific or regulatory document by specialized writers known as the "medical writers". Medical writers might not be the real scientists who did the authentic research, but work with the physicians / scientists concerned in the creation of data, and thereby assist to present that data in appropriate and clear way.
Alex Parker

Bristol-Myers Squibb gets FDA breakthrough designation for daclatasvir-based regimen - 0 views

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    PBR Staff Writer Published 25 February 2014 Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).
Alex Parker

Pluristem files orphan drug application to US FDA for preeclampsia - 0 views

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    PBR Staff Writer Published 21 February 2014 Israel-based Pluristem Therapeutics has submitted its application to the US Food and Drug Administration seeking Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.
Alex Parker

Vertex gets FDA approval for Kalydeco sNDA - 0 views

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    PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).
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