Navigation Links
So Long, Old Friend: The End of the Blockbuster Drug Era? What 2008 Holds for Bringing Drugs to Market
Date:11/15/2007

Hoffmann-La Roche Inc. CEO George Abercrombie, Pfizer R&D Head Martin Mackay, HHS Deputy Secretary Tevi Troy, Former CMS Administrator & FDA Commissioner Mark McClellan Headline Agenda at FDA/CMS Summit 2007

WASHINGTON, Nov. 15 /PRNewswire-USNewswire/ -- It's shaping up to be a record year for drug approvals. Unfortunately for the biopharma sector and investors, it's a record low. The Food and Drug Administration is on track to grant marketing approval to 18 or fewer new drugs in 2007, and pipelines are not looking better in the coming years. For the research and development and marketing executives responsible for getting new drugs to customers, the level of unpredictability may be unprecedented. And Washington lawmakers and regulators are driving the uncertainty. Yesterday's blockbuster will not be the prototype for future drug development. Sweeping new legislation is reforming the FDA and changing how drugs are developed; Medicare is radically altering product economics; and Wall Street is looking for the next big thing.

(Logo: http://www.newscom.com/cgi-bin/prnh/20071115/DC07546LOGO )

The FDA/CMS Summit, taking place December 6-7 in Washington, D.C., will feature the key decision makers from government and industry to help biopharmaceutical executives understand what regulatory and policy developments mean for research and commercial success.

"Today may look a lot like yesterday, but the rules of the game have fundamentally changed," said Cole Werble, editor-in-chief of The RPM Report, the lead sponsor of the conference. "Industry needs to learn what recent changes to FDA law mean and what the impact might hold for drug development and marketing. The FDA/CMS Summit provides leaders in industry key insight from policy-makers who have been involved in these changes."

The FDA/CMS Summit provides health care executives with an exclusive oppo
'/>"/>

SOURCE Windhover Information Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Novel Angiogenic Drugs, Including a Future Blockbuster from Genzyme, Could Revolutionize Treatment of Peripheral Arterial Disease
2. Merck Will Obtain Blockbuster Antidiabetic Drug Sales in Type 2 Diabetes Market by 2011
3. Forest Laboratories Announces Federal Appeals Court Upholds Lexapro(R) Patent Decision
4. Stem Cell Science Holds Opportunities as Important Tool for Diabetes Research Beyond Cell-Based Treatments
5. Nobel Award in Medicine Holds Strong Messsage for Animal Activists
6. Isis Enters Broad Collaboration With Ortho-McNeil, Inc. for the Discovery, Development and Commercialization of Antisense Drugs to Treat Metabolic Diseases
7. Thomson Scientific Publishes Who Is Making The Biggest Splash? - A Quarterly Review of Scientific Literature on Drugs and Therapies From April - June 2007
8. Isis Pharmaceuticals and Thomas, McNerney & Partners Announce That the Newly Formed Altair Therapeutics Will Develop Antisense Drugs for Respiratory Conditions
9. First New Class of Platinum-Based Chemotherapy Drug Candidates in 30 Years Demonstrate Ability to Kill Tumors Resistant to Currently Marketed Platinum Drugs
10. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
11. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... ON (PRWEB) January 15, 2014 AudioNotch ... experimental new therapy for the treatment of tinnitus. Patients ... tinnitus frequency, and over a period of weeks to months, ... Sound Therapy in two forms: Notched Music and Notched White ...
(Date:1/14/2014)... Histogen, Inc., a regenerative medicine company ... under simulated embryonic conditions, today announced that they have ... Inc. for physician-dispensed aesthetic products containing Histogen’s proprietary multipotent ... is an amendment to the existing license between Histogen ...
(Date:1/14/2014)... Texas , Jan. 14, 2014 The ... and research medicinal plants and therapeutic derivatives thereof ... health professionals, and researchers about the challenges of ... http://photos.prnewswire.com/prnh/20100430/DC95601LOGO ) The Society ...
(Date:1/14/2014)... , Jan. 14, 2014  RXi Pharmaceuticals Corporation (OTCQX: ... and commercializing innovative therapies addressing major unmet medical ... received the Notice of Allowance from the United ... self-delivering RNAi compounds (sd-rxRNA®), for the treatment of ...
Breaking Biology Technology:Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 2Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8RXi Pharmaceuticals Receives US Notice of Allowance for a Key Patent Relating to its Self-Delivering Technology with sd-rxRNAs targeting CTGF, including RXI-109, for the Treatment of Fibrotic Disorders 2RXi Pharmaceuticals Receives US Notice of Allowance for a Key Patent Relating to its Self-Delivering Technology with sd-rxRNAs targeting CTGF, including RXI-109, for the Treatment of Fibrotic Disorders 3
... Wis. - At least six Wisconsin biotech companies ... an event that may be another signal of the ... , ,The Wisconsin companies will travel to Minneapolis for ... by the Biotechnology Industry Organization . Companies will ...
... Madison, Wis. - The Center for Technology Transfer ... Spinworks LLC, a company that has developed a series ... to reduce usage of natural gas in their furnaces. , ... and will help Spinworks expand its business and product offerings, ...
... Active Air Networks Wisconsin said Monday it ... to consumers and business users throughout Wisconsin communities. ... multiple villages and towns throughout Washington County. Its citywide ... 802.11 a/b/g Wi-Fi standards. The service is mobile, yet ...
Cached Biology Technology:Six Wisconsin firms to present at BIO Mid-America VentureForum 2Six Wisconsin firms to present at BIO Mid-America VentureForum 3Tech center supports energy-saving device for heat-treating plants 2
(Date:4/22/2014)... from NeuroPhage Pharmaceuticals, Inc. have engineered a series ... neurodegenerative diseases that are characterized by misfolded proteins, ... molecules are based on what the Company calls ... recognizes a characteristic common to many toxic, misfolded ... This approach provides NeuroPhage with an array of ...
(Date:4/21/2014)... at The University of Texas at Dallas have ... carbon structures used in the manufacture of many ... Paul Pantano, associate professor of chemistry, and Dr. ... recently received a $459,000, three-year grant from the ... the National Institutes of Health, to track how ...
(Date:4/21/2014)... colleagues from Pittsburgh University, find how lipid mediators ... Nature Chemistry. Lipid mediators are molecules playing an ... to some of them has earned a Nobel ... "cellular power plants", the organelles where oxidation of ... (ATP), a molecule universally used for storage and ...
Breaking Biology News(10 mins):NeuroPhage discovers GAIM-changing molecules to combat Alzheimer's and related diseases 2NeuroPhage discovers GAIM-changing molecules to combat Alzheimer's and related diseases 3Grant to fund research on possible cell contaminants 2Grant to fund research on possible cell contaminants 3The anti-inflammatory factory 2The anti-inflammatory factory 3
... Western Europe,s largest lakes, Lake Geneva, in large enough quantities ... that these small bits of plastic can be harmful to ... waterborne organisms, the full extent of their consequences in lakes ... is being extending under a mandate by the Swiss Federal ...
... paper published in the Journal of Animal Science ... when including distillers dried grains with solubles (DDGS). Some ... the fat-softening effects of DDGS. Firmer fat means longer-lasting ... found that including saturated fats in DDGS diets makes ...
... to threaten common ash trees across Europe, new research in ... impact of forest diseases to discover if diseases played a ... large-scale pathogen outbreaks were much more infrequent in the past, ... locations, such as the international seed trade, is a major ...
Cached Biology News:Microplastic pollution prevalent in lakes too 2Microplastic pollution prevalent in lakes too 3Saturated fats do not yield better bacon 2
Mycoplasma tested...
Human PDGF, CF...
... Lacks the mycobacteria found ... side-effects. For this reason, Incomplete, ... Freund's Adjuvants may be used to produce water-in-oil ... emulsions stimulate high and long-lasting antibody responses which ...
Alexa Fluor 350/488/594 Filter Set (Semrock Brightline) *mounted* *Zeiss Axio AF...
Biology Products: