| HOME >> BIOLOGY >> TECHNOLOGY |
Stringent, Yet Ill-Defined, Approval Standards Make it Difficult for Companies to Bring Hospital Antibiotics to Market, According to a New Report from Decision Resources
WALTHAM, Mass., Nov. 12 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Gilead will topple GlaxoSmithKline (GSK) as the top player in the anti-infectives drug market in 2014. According to the new report entitled Commercial Outlook for Anti-Infectives: 2003-2014, GSK's fall will be due to generic erosion and a sparse anti-infectives pipeline. Gilead's rise will be due to its remarkable growth in HIV driven by its blockbuster products, Truvada and Atripla.
The report also finds that increasingly stringent, yet ill-defined, approval standards make it difficult for companies to bring hospital antibiotics to market. The FDA's heightened scrutiny of hospital antibiotics has resulted in extended review periods, cancelled advisory meetings, postponed PDUFA dates and the issuance of multiple consecutive approvable letters requesting further data.
"We believe there is discordance between the FDA's expectations and the submission data presented by drug developers," said Sylvia Eash, Ph.D., analyst at Decision Resources. "As a result, the lack of FDA guidance that clearly defines these standards has emerged as the greatest challenge for drug developers who are left to wonder how the approval process will change while their late-stage hospital antibiotic candidates await further regulatory decisions. Agents suffering from these regulatory uncertainties include J&J's Doribax, Pfizer's Zeven, Theravance's telavancin and J&J's ceftobiprole."
The report is the first of its kind from Decision Resources, outlining
the entire drug market for anti-bacterials, anti-virals and anti-fungals.
Each drug class is thoroughly dissected with robust data on major brands,
supporting brands, lat
'/>"/>
| SOURCE Decision Resources Copyright©2008 PR Newswire. All rights reserved |
Related biology technology :
1. diaDexus, Inc. and Living Heart Foundation Offer the PLAC(R) Test to Detect Hidden Risk for Heart Attack and Stroke in Retired NFL Players
2. SURGEX(TM) Becomes the Official Sports Nutrition Drink of Former NBA Player Dee Brown and his Edge Basketball Training Facility
3. Backe Digital-Brand-Marketing Blends Traditional Advertising with Expanded Digital Services
4. Amicus Therapeutics to Present at Lazard Capital Markets Healthcare Conference
5. Spherix Transfers Stock Listing to Nasdaq Capital Market
6. MichBio Expo Will Feature Sessions for Michigan Manufacturers Interested in Entering Medical Device Market
7. Calorimeters and Thermal Analysis Equipment Market to Exceed $539 Million by 2012, According to New Report by Global Industry Analysts
8. Former NASDAQ International President Among Execs Launching Firm to Access Global Markets
9. WellSpring Pharmaceutical Corp. Announces Hire of Wayne Miller as Vice President, Sales & Marketing, Consumer Brands
10. Osteotechs Next Generation Grafting Material, MagniFuse(TM) Bone Graft, a Breakthrough in Bone Regeneration; MagniFuse(TM) Bone Graft seeks to redefine the standard of care in the U.S. bone graft substitute market estimated to be in excess of $1.2 billio
11. Cell/Tissue Culture Supplies Market to Reach $4.97 Billion by 2012, According to New Report by Global Industry Analysts
| Copyright © 2003-2012 Bio-Medicine. All rights reserved. ABOUT | CONTACT US | DISCLAIMER | PRIVACY POLICY | TERMS AND CONDITIONS |  |