Navigation Links
Concern over fast tracking of new drugs

Concerns over the fast tracking of new drugs for commercial licensing are raised by a senior doctor in this week's BMJ.

It follows approval of natalizumab, a new drug for multiple sclerosis, and its recall three months later, after three trial patients developed a life threatening condition while being treated.

Natalizumab was licensed by the US Food and Drug Administration in 2004 for use in relapsing multiple sclerosis on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of $2bn.

Around 3000 patients took part in the trials and nearly 5000 patients have been treated in the United States since it became commercially available. In the United Kingdom, natalizumab was due for appraisal by the National Institute for Health and Clinical Excellence in 2006.

But on 28 February 2005, natalizumab was recalled after three trial patients developed progressive multifocal leucoencephalopathy (PML), a rapidly progressive neurodegenerative disease. Two of the patients died.

The approval of natalizumab and its recall after three months raises questions about the fast tracking of new drugs by the FDA for commercial licensing, says the author, consultant neurologist Abhijit Chaudhuri. It also highlights the potential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, and safety is lacking.

Short term solutions for a chronic disease like multiple sclerosis are not likely to be effective, and experience with natalizumab should be taken as a signal to change the way we treat this disease, he concludes.


'"/>

Source:BMJ-British Medical Journal


Page: 1

Related biology news :

1. Findings have implications for tracking disease, drugs at the molecular level
2. Radio-tracking associated with dramatic shift in water vole sex ratio
3. UQ researcher tracking key to healing the brain
4. How satellite tracking revealed the migratory mysteries of endangered Atlantic loggerhead turtles
5. New way of tracking muscle damage from radiation
6. Researchers identify target for cancer drugs
7. MetaChip provides quick, efficient toxicity screening of potential drugs
8. Newly discovered pathway might help in design of cancer drugs
9. UNC launches study of liver injury caused by drugs
10. UCLA study assesses cost-effectiveness of Hepatitis B drugs
11. Sponges as drugs
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Concern over fast tracking new drugs

(Date:12/17/2014)... 2014 Valencell, a leader in performance biometric ... to industry leaders such as Intel, Jabra, Atlas, and ... wearable products. These products will be showcased at CES ... Vegas . "Our partners choose ... robust – with the clinical data to back it ...
(Date:12/17/2014)... DENVER , Dec. 16, 2014  Automation ... is this more evident than at international borders. ... secure document scanners have allowed veteran travelers to ... Automated Passport Control (APC) Kiosks at an increasing ... the globe. According to ...
(Date:12/11/2014)... , Dec. 09, 2014 Research and ... ( http://www.researchandmarkets.com/research/twhjll/biometrics_market ) has ... in the APAC Region 2015-2019"  report to their ... in this market is advances in technology. With ... upgrade biometric solutions to the latest standard that ...
Breaking Biology News(10 mins):Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2Biometrics Market in the APAC Region 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2
... An international team of scientists, including researchers at Columbia University ... common malaria parasites require for survival at each stage of ... new approach to combating malaria, one of the world,s deadliest ... of the journal Nature . "Perhaps the ...
... 2013 A Ben-Gurion University of the Negev (BGU) study ... Stress Disorder (PTSD) if their mother is already afflicted. ... & Anxiety , while fewer than 10 percent (8.4 percent) ... fifth (21 percent) of their children presented PTSD symptoms. Children ...
... Spring Harbor, NY A team of researchers at Cold ... DNA called an enhancer element that enables cancerous blood cells ... that is incurable in 70% of patients. Just as ... new class of promising drugs one version of which ...
Cached Biology News:Study finds new vulnerability in malaria parasite 2Scientists discover how leukemia cells exploit 'enhancer' DNA elements to cause lethal disease 2Scientists discover how leukemia cells exploit 'enhancer' DNA elements to cause lethal disease 3
(Date:12/24/2014)... (PRWEB) December 23, 2014 Nashville Fertility ... was elected treasurer for the American Society for Reproductive ... knowledge and research in reproductive medicine. In his ... seat on the executive board and will have a ... Dr. Hill has actively supported ASRM since 1984 when ...
(Date:12/24/2014)... Dec. 23, 2014 China Biologic Products, ... a leading fully integrated plasma-based biopharmaceutical company in ... its majority-owned subsidiary, Shandong Taibang Biological Products Co. ... from the China Food and Drug Administration (the ... As previously disclosed in the Company,s public filings, ...
(Date:12/24/2014)... , Dec. 23, 2014 Sigma-Aldrich Corporation ... the waiting period under the Hart-Scott-Rodino Antitrust Improvements ... expired on December 22, 2014, thereby completing the ... for the acquisition of the Company by Merck ... clearance satisfies another condition to closing the transaction, ...
(Date:12/22/2014)... December 22, 2014 The Center ... leader of technical training across the life sciences industry, ... Management (SCDM) to provide the organization's members with ... —providing access to the more than 350 sessions across ... with 10% off when registering for a public ...
Breaking Biology Technology:Nashville Fertility Center Announces Dr. George A. Hill Selected to Serve as ASRM Treasurer for 2014-15 2Nashville Fertility Center Announces Dr. George A. Hill Selected to Serve as ASRM Treasurer for 2014-15 3China Biologic Receives GMP Certification for New Coagulation Factor Facility 2China Biologic Receives GMP Certification for New Coagulation Factor Facility 3Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 2Acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany, Receives U.S. Antitrust Clearance 3CfPIE Announces Partnership with the Society for Clinical Data Management 2CfPIE Announces Partnership with the Society for Clinical Data Management 3
... SPEX ) reported that the Nasdaq Stock Market ... common stock from the Nasdaq,Global Market to the Nasdaq ... on the Nasdaq Capital Market on November 11, 2008., ... market tier designations for,Nasdaq-listed stocks, and presently includes over ...
... Company Will Host a Conference Call Today To Discuss the Data ... ... (Nasdaq: SGMO ) announced today top-line data from its,SB-509-601 clinical ... Therapeutic(TM) program to develop SB-509 for diabetic,neuropathy (DN). The data demonstrate ...
... 10 /Xinhua-PRNewswire-FirstCall/ -- Shengtai,Pharmaceutical, Inc. (OTC Bulletin Board: ... distributor of high-quality,pharmaceutical grade glucose products in China, ... the three months ended September 30, 2008,after the ... 13, 2008.,Management will conduct a conference call on ...
Cached Biology Technology:Spherix Transfers Stock Listing to Nasdaq Capital Market 2Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601 2Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601 3Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601 4Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601 5Sangamo BioSciences Announces Results From Diabetic Neuropathy Clinical Trial SB-509-601 6Shengtai Pharmaceutical Schedules 2009 First Quarter Financial Results and Conference Call 2Shengtai Pharmaceutical Schedules 2009 First Quarter Financial Results and Conference Call 3
Mouse monoclonal [B314.1 (MAC 387)] to Macrophage L1 protein Calprotectin (rating: ****) ( Abpromise for all tested applications)....
MOUSE ANTI HUMAN CYTOKERATIN 1-8...
Request Info...
... Polyoxyethylene Lauryl Ether 30% ... Kathon Preservative. Surfactant. Clear ... immunohistochemistry is 1 mL ... solution added to 400 ...
Biology Products: