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Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway
2013-02-19 11:49:02| drugdiscoveryonline Downloads
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
Tags: plan
development
drug
pathway
GlaxoSmithKline's experimental HIV, AIDS drug to get priority review
2013-02-19 02:02:39| Biotech - Topix.net
U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.
Tags: review
drug
aids
priority
GSK wins priority status for new HIV drug in U.S
2013-02-15 19:10:30| Biotech - Topix.net
U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.
Bayer Submits New Drug Application for Riociguat for the Treatment of ...
2013-02-13 12:56:21| Chemicals - Topix.net
Bayer HealthCare today announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for riociguat, an investigational compound for the treatment of pulmonary arterial hypertension and persistent/recurrent chronic thromboembolic pulmonary hypertension after surgical treatment or inoperable ... (more)
Tags: the
of
application
treatment
Tissuegen and Biomedical Structures develop drug delivery platform for implantable devices
2013-02-13 06:00:00| Nonwovens Industry Breaking News
Enables a wider variety of drugs and biologically-based entities to be effectively used in implantable fiber-based medical devices.
Tags: delivery
develop
drug
devices
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