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Novartis said it will work diligently with the FDA to resolve the partial clinical hold and resume the study.
Makena has been approved to decrease preterm birth in pregnant women with a previous spontaneous preterm birth.
Reynolds claimed that his company’s product, called NeuroRelease, could essentially end paralysis.
The U.S. Department of Justice said the two charitable organizations, Good Days and Patient Access Network Foundation, allowed seven pharmaceutical companies to funnel money through their organization to provide Medicare patients with assistance in paying for medications developed by those companies.
Motif Bio plc announced that the Company has signed an agreement with the Walter Reed Army Institute of Research to conduct pre-clinical testing to evaluate novel combinations with iclaprim to improve safety and efficacy administered by a novel enhanced aerosol technology.
In its announcement on Thursday, the FDA said its preliminary tests of alternative antacid treatments such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole) currently show no NDMA at this time based on testing.
Imugene Limited announced that prominent City of Hope researchers Yanghee Woo, MD, Associate Clinical Professor, Department of Surgery and Director, Gastroenterology Minimally Invasive Therapy Program, together with Yuman Fong, MD, Professor and Chair of the Department of Surgery, received a AU$564,173 US Department of Defense Grant
This morning’s approval from the U.S. Food and Drug Administration marks the 11th therapeutic indication for Botox, a product tent pole for Ireland-based Allergan.
GlaxoSmithKline’s PARP inhibitor Zejula has been approved for wider use in some cancers.
The organizations hope the funding will result in clinical trials in the U.S. and countries in sub-Saharan Africa in the next seven to 10 years. Francis Collins, director of the NIH, said they would focus on “access, scalability and affordability.”
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