Tag Archives: drug approvals

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

FDA Approves Fewer New Drugs, but acts fast on innovative products As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near-record of 39 innovative new drugs approved in 2012. In addition, the Center for […]
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Frontrunners in Innovation: New Drug Approvals 2013

Frontrunners in Innovation: New Drug Approvals 2013 Trying to nail down the actual number of new drugs approvals in 2013 is like trying to swat a fly—it can be highly illusive.  Safe to say, however, as 2013 drew to a close,  the total number of new did not match 2012’s  high of 39. And yet, […]
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New Funding and Approval Pathways Prove Popular

By Rita Peters, Editorial Director, BioPharm International. Compared to other manufacturing and technology industries, the bio/pharmaceutical industry has one of the longest product development timelines. The research, development, testing, and regulatory review process typically extends for more than a decade, often exhausting the financial resources and commitment of investors. For patients with unmet medical needs, the […]
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Will "Robust Pipeline" Yield More New Drugs?

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in […]
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Sanofi's Aubagio to Square Off Against MS Injectables

The most obvious competitors for Sanofi’s Aubagio, the second oral multiple sclerosis (MS) drug to receive FDA approval, would appear to be Novartis’ Gilenya, and Biogen Idec’s hotly anticipated BG-12, which has a PDUFA date scheduled for December 28. Both Gilenya and BG-12 are administered orally as opposed to injected, but execs at Genzyme – […]
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