Tag Archives: drug approvals

Will "Robust Pipeline" Yield More New Drugs?

By Jill Wechsler | Published: January 21, 2013
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

By Ben Comer | Published: September 13, 2012
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 – [...]
Posted in FDA, Regulatory, Safety, Strategy, pricing | Also tagged , , , | 2 Comments

Patent Filing to Drug Approval: A Difficult Journey Even for the Mighty

By Guest Blogger | Published: March 20, 2012
By Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit. The UK Financial Times this week (March 18) flagged up data from Withers & Rogers, a London-based IP firm, showing how the numbers of patent filings from the ten leading pharma companies has dropped in recent years. According to the law firm, only 129 “patent families” [...]
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FDA Approvals Down on Last Two Years

By Jennifer Ringler | Published: February 23, 2011
A new FDA report summarizes the new drug approvals for 2010, and highlights some surprising numbers compared to years past. According to a recent FDA report, FDA’s Center for Drug Evaluation and Research (CDER) approved 21 New Molecular Entities (NMEs) in 2010, which is less than in 2009 (26) and 2008 (24), but greater than the [...]
Posted in FDA, Regulatory | Also tagged | 1 Comment