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Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.
"Although we're several days into sequestration, details about the full impact of funding cuts are still hazy," Kim Lufkin, communications officer of the Global Health Technologies Coalition, writes in the group's "Breakthroughs" blog, noting, "On [March 1], the Office of Management and Budget released a report to Congress, which details funding cuts required to offset $85 billion in the fiscal year 2013 budget."
Now, a new study published on the preprint server medRxiv in July 2020 discusses the explanation in terms of the biological aging markers in patients with severe disease, rather than the chronological age.
Bristol-Myers Squibb Company today announced the full results, published in the New England Journal of Medicine, from a Phase II clinical trial in patients with hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin ('null responders').
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