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The U.S. Food and Drug Administration’s performance in its review of new drug applications varies widely depending on the therapeutic area involved, according to a new report from the California Healthcare Institute and the Boston Consulting Group. The report suggests that the agency could learn from areas in which it is high performing to improve its approach in others. We spoke to David Gollaher, CEO of the California Healthcare Institute, about the report, why the numbers used to track FDA performance may provide an incomplete picture, and the need for new measures of success. Read More
Deals
- GSK Goes Hostile
Pharma keeps offer at $13 per share and goes directly to shareholders. Read More - Daiichi Sankyo Enters Biosimilars Arena with Coherus BioSciences
Newly launched biotech employs seasoned production team with a global perspective. Read More
Regulatory
- User Fee Deal Eased Some Burdens, Exacerbated Others, Report Says
Tufts Center for the Study of Drug Development says supplemental new drug and biologic licenses grew more onerous. Read More - Groups Weigh in on Biosimilars
Naming, interchangability key focus of discussions. Read More
Healthcare Economics
- Use of Avastin for Eye Disease Could Save NHS $136 Million Annually
Trial pitting Avastin against Lucentis finds they yield similar results for wet-AMD. Read More
Patents
- Bayer Appeals Forced Licensing in India
Issue creates friction between government trade representatives. Read More
Drug Development
- Vertex’s Cystic Fibrosis Considered ‘Game-Changer’
Interim mid-stage data on combination therapy impresses investors. Read More
HIV/AIDS
- Gilead's Truvada Gains Support for HIV Prevention
Risk-reducing use would be a first. Read More
Trials and Tribulations
- Blech, One-Time "King of Biotech," Pleaded Guilty to Manipulating Stock Prices
The weekly round-up of failed trials, missed targets, and other business mishaps. Read More
Business Strategy
- Protalix Approval a Win for Its Manufacturing Technology
Podcast: May 7, 2012 Read More
- The Burrill Report (May 14, 2012): Keeping Score at the FDA
Listen to the latest edition from The Journal of Life Sciences. Browse all podcasts
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The Burrill Report
May 2012
May 2012
Download a free copy of the May 2012 issue of The Burrill Report. 2011—Focus on M&A and Partnering
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Podcast
Protalix Approval a Win for Its Manufacturing Technology
David Aviezar, CEO of Protalix, discusses the FDA approval of the company's Gaucher disease drug, the advantages of Protalix's manufacturing process offers, and the company’s strategy to pursue biosimilars.
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By the numbers
Daiichi Sankyo Enters Biosimilars Arena with Coherus BioSciences
Daiichi Sankyo and the newly launched company Coherus BioSciences are partnering to develop and commercialize biosimilars in certain Asian countries.
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