IN FOCUS FEATURE
Drug Development and Regulatory Approval Primer
FROM OUR WEB SITE
- BioMedomics Joins the Hamner Accelerator for Translational Bioscience
- Plant-Made Biotechnology Has a Growing Future
- Biogen Idec Wins FDA Approval for Crohn's Disease Treatment
- BioDelivery Sciences, Meda to Study More Pain Patch Uses
- 2007 Annual Report Available
- Wake Forest, Harvard Scientists Tap Amniotic Fluid For Stem Cells
- N.C. Pavilion Sponsors Sought for BIO 2008
- Rick Weddle, CEO of the Research Triangle Foundation, has been named president of the North American division of the International Association of Science Parks.More.
- Business Leader magazine has named Joseph DeSimone, Liquidia Technologies founder and Distinguished Professor of Chemistry at UNC-Chapel Hill, as one of 24 Triangle Impact Entrepreneurs for his contributions to innovative nanoparticle therapeutics and a targeted drug delivery platform at Liquidia Technologies. The awards will be presented March 3. More.
- CeNeRx BioPharma, a Research Triangle Park-based company developing and commercializing treatments for diseases of the central nervous system, has successfully completed the Phase l clinical program for Tyrima, its lead candidate for the treatment of depression and anxiety. More.
From Our Web Site
BioMedomics Joins the Hamner Accelerator for Translational Bioscience
The accelerator program provides an opportunity for leaders of emerging companies to access resources at The Hamner while also partnering on research projects and grant funding.
Plant-Made Biotechnology Has a Growing Future
Organized by North Carolina's Northeast Commission and the Eastern Office of the North Carolina Biotechnology Center, the mission of the Northeast Biotechnology Task Force is to build on the strengths of the research work conducted by scientists at North Carolina State University's Vernon James Research, the Extension Center in Roper, and East Carolina and Elizabeth City State universities.
Biogen Idec Wins FDA Approval for Crohn's Disease Treatment
The drug, manufactured at the company's Research Triangle Park plant, is currently used to treat multiple sclerosis. Biogen Idec and Elan Corp. of Dublin, Ireland, have a partnership to develop and market the formulation behind Tysabri.
BioDelivery Sciences, Meda to Study More Pain Patch Uses
Raleigh-based BioDelivery Sciences plans to expand its clinical development program to seek more pain indications for its lead product, BEMA Fentanyl.
2007 Annual Report Available
Read about the Biotechnology Center’s accomplishments during the fiscal year.
Wake Forest, Harvard Scientists Tap Amniotic Fluid For Stem Cells
Tengion, a tissue-engineering company associated with the Wake Forest University Institute for Regenerative Medicine, will begin its third Phase II clinical trial of its Neo-Bladder Augment derived from a patient's own (autologous) cells.
N.C. Pavilion Sponsors Sought for BIO 2008
The N.C. Department of Commerce is accepting sponsorships for the pavilion-style exhibit at this year's BIO International Convention in San Diego, Calif.
In Focus
Drug Development and Regulatory Approval Primer
By Robert A. Lindberg, PhD, RACBATON Director
The commercial development of most biotechnology products is subject to extensive regulation by U.S. and international authorities. In the United States, these agencies include (but are not limited) the Food and Drug Administration, the U.S. Department of Agricultureand the Environmental Protection Agency.
A primary interest of these agencies is to assure the safety and efficacy of new products for the public. Development, manufacturing and use of biotechnology products in a manner compliant with federal regulations often represent the greatest financing challenges to biotechnology companies.
The FDA regulates pharmaceutical and biological therapeutics, diagnostic and reagent products, medical devices, radiologic imaging devices, foods, cosmetics and so on. The primary concern of the FDA is public safety, although it also protects the public from inaccurate or overstated claims of benefit or effect.
News from Other Sites
North Carolina Shows How a State Builds a Biotech Industry
"Sending kids to those biotech degree programs requires good public schools, and the North Carolina science standards are considered among the very best in the nation. That's no accident."
From the Thoughts From Kansas (Blog)
BCC has a Slimy Solution for Fuel Supply
"The answer to the world's energy problems could eventually be found in a slimy little plant. The little plant, in turn, could be found right now, sprawling across your aquarium. It's algae. It's better known as a fast-multiplying nuisance than as something that could, if large industrial production is feasible, create a virtually inexhaustible energy source.
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From the (Wilmington) Star-News
Migraine Pill on Track for Decision by May 15
"Pozen could win regulatory approval in mid-May for its long-awaited migraine pill after the Chapel Hill company met a key deadline to answer safety concerns raised by the Food and Drug Administration."
From the (Raleigh) News and Observer
Community Watch
Please send Community Watch items to Jim Shamp.
Save the Date
Mar. 6
MedTech 2008
(Durham)
May 19-20
Biotech 2008
(Winston-Salem)
June 17-20
BIO 2008 Conference
(San Diego)
View our complete listing of events across North Carolina.
This newsletter was sent Thursday, Jan. 17, 2008. For the latest North Carolina biotechnology industry headlines, please visit the news section of our Web site.
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