Navigation Links
Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
Date:12/13/2007

preclinical study to evaluate indiplon administration during the

third trimester of pregnancy.

"While we are disappointed in the FDA action, we will accept the FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required," said Gary A. Lyons, President and CEO of Neurocrine.

About Neurocrine

Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. The product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, endometriosis, irritable bowel syndrome, pain, and diabetes. Indiplon was licensed from DOV Pharmaceutical in 1998. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties relating to Neurocrine's indiplon program that could cause actual results to differ materially from those indicated in the forward-looking statements. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to; risk that the Company will not be able to address issues and or requests set forth in the action letter from the FDA in a timely manner if at all; risk that the Company will not be able to address issues and or requests set forth in the action letters from the FDA in a manner acceptable to the FDA if at all; the risk that FDA may reject any future indiplon regulatory filings or find them incomplete or insufficient; risk that indiplon approval and subsequent commercialization may be significantly delayed; and the other risks described in Neurocrine's annual report on Form 10-K for the year ended Dec
'/>"/>

SOURCE Neurocrine Biosciences, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Neurocrine Biosciences to Present at the BioCentury: Newsmakers in the Biotech Industry Conference
2. Neurocrine Biosciences to Present at the Thomas Weisel Partners Healthcare Conference
3. Neurocrine Biosciences to Present at the Bear Stearns Healthcare Conference
4. Neurocrine Biosciences to Present at the A.G. Edwards Annual Emerging Growth Conference
5. Neurocrine Biosciences to Present at the UBS Global Life Sciences Conference
6. Neurocrine Biosciences Announces Conference Call and Webcast to Present Third Quarter 2007 Financial Results
7. Neurocrine Biosciences and Dainippon Sumitomo Pharma (DSP) Announce Agreement to Develop and Commercialize Indiplon in Japan
8. Neurocrine Biosciences Announces Conference Call and Webcast to Provide Indiplon Update
9. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
10. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
11. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2015)... , ... July 28, 2015 , ... VetStem Biopharma will ... stem cell credentialing course to local area veterinarians. , The tour and course will ... units at no charge) at VetStem’s Poway facility. Staff members are welcome to attend ...
(Date:7/28/2015)... , July 28, 2015 Tauriga Sciences, Inc. ... life sciences company, today announced that its stockholders approved ... common stock of the Company from 1,000,000,000 to 2,500,000,000 ... 27, 2015 at the Law Offices of Nixon Peabody ... Special Meeting, there were 480,655,929 shares of common stock ...
(Date:7/28/2015)... MORRISTOWN, N.J. , July 28, 2015 /PRNewswire/ ... its second Phase 1 clinical trial with MMI-0100, ... that is being developed for pulmonary disorders characterized ... the United Kingdom , is ... study further evaluating the safety and tolerability of ...
(Date:7/28/2015)... OF PRUSSIA, Pa. , July 28, 2015 /PRNewswire/ ... U.S. Food and Drug Administration has accepted for review ... investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment ... met all primary endpoints. Hemophilia ... deficient or defective factor VIII; nearly all affected patients ...
Breaking Biology Technology:VetStem Biopharma weekly veterinary continuing education classes and GMP manufacturing facility tour 2Tauriga Sciences, Inc. Stockholders Approve Increase In Authorized Common Stock 2Tauriga Sciences, Inc. Stockholders Approve Increase In Authorized Common Stock 3Moerae Initiates Lipopolysaccharide (LPS) Challenge Study of Inhaled MMI-0100 for Pulmonary Disease Following Encouraging Safety and Tolerability Observed in Single Ascending Dose Phase 1 Study 2U.S. FDA Accepts for Review CSL Behring's Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A 2U.S. FDA Accepts for Review CSL Behring's Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A 3
... Kristina Lind and Mikael Kubista, TATAA Biocenter, Medicinaregatan 7A/B,405 30 Gteborg, Sweden , ... Introduction , A technique for ... Sano et al. (1992). It combines the molecular recognition of antibodies , ... similar , to conventional enzyme-linked immunosorbent assays (ELISA) ...
... Difference gel electrophoresis (DIGE) is a relatively straightforward , ... using fluorescent , dyes. The technique, originally ... cyanine (Cy) dyes to differentially label proteins separated by 2-D gel , ... can be achieved by scanning the multiplex ...
... Joella Blas, and Efthalia Gerasimopoulos, Bio-Rad Laboratories, Inc.,Hercules, CA 94547 USA , ... Introduction , Bio-Plex assays allow ... volume of sample. The assays are based on detection of signal from ... have bound to each target protein. , ...
Cached Biology Technology:Real-Time Immuno-PCR on the iCycler iQ System, Rev A 2Real-Time Immuno-PCR on the iCycler iQ System, Rev A 3Real-Time Immuno-PCR on the iCycler iQ System, Rev A 4Real-Time Immuno-PCR on the iCycler iQ System, Rev A 5Imaging and Analysis of DIGE Product Information Sheet, Rev B 2Imaging and Analysis of DIGE Product Information Sheet, Rev B 3Imaging and Analysis of DIGE Product Information Sheet, Rev B 4Imaging and Analysis of DIGE Product Information Sheet, Rev B 5Imaging and Analysis of DIGE Product Information Sheet, Rev B 6Imaging and Analysis of DIGE Product Information Sheet, Rev B 7Feasibility of Multiplexing Bio-Plex Total Target and Phosphoprotein Assays 2Feasibility of Multiplexing Bio-Plex Total Target and Phosphoprotein Assays 3Feasibility of Multiplexing Bio-Plex Total Target and Phosphoprotein Assays 4
(Date:7/23/2015)... Aware, Inc. (NASDAQ: AWRE ), a leading supplier of ... second quarter ended June 30, 2015.  Revenue ... decrease of 33% compared to $6.8 million in the same ... 2015 was $0.3 million, or $0.01 per diluted share, which ... the same period a year ago.  Lower ...
(Date:7/20/2015)...  Acuity Market Intelligence,s latest research "The Global ... and Privacy" forecasts that between 2014 and 2020 ... downloaded to smart mobile devices by 2.2 billion ... projected to generate more than $67.9 billion in ... period.    "Biometrics is at the ...
(Date:7/9/2015)... July 9, 2015  Unchained Labs just can,t ... acquisition of Avid Nano. Avid Nano designs, develops ... systems.    Also today, Unchained Labs ... easiest to use protein sizing system. The pUNk ... protein,s hydrodynamic size, size distribution, aggregation population and ...
Breaking Biology News(10 mins):Aware, Inc. Reports Second Quarter 2015 Financial Results 2Aware, Inc. Reports Second Quarter 2015 Financial Results 3Aware, Inc. Reports Second Quarter 2015 Financial Results 4Aware, Inc. Reports Second Quarter 2015 Financial Results 5Aware, Inc. Reports Second Quarter 2015 Financial Results 6Biometrics on Smart Mobile Devices to Redefine Digital Identity with 12.9 Billion Biometric App Downloads between 2014 and 2020 2Unchained Labs just can't get enough, acquires Avid Nano, rocks out the new pUNk! 2
... 1990s, biomedical researchers interested in finding the causes and ... the broad interconnected regulatory networks of the human body ... genetic information seemed to hold the key toward vastly ... there,s been a reappraisal, says Mayo Clinic anesthesiologist and ...
... Fishes account for over half of vertebrate species, but ... fairly well understood by scientists for decades, knowledge about relationships ... now. A team of scientists led by ... Arts and Sciences at the University of Oklahoma, published two ...
... carbon created during combustion will remain in soil than have ... in the ground in order to restrain climate change will ... black carbon will dissolve from soil to rivers. The flux ... was estimated in a research article published in Science ...
Cached Biology News:Mayo Clinic anesthesiologist earns APS's Walter B. Cannon Award 2Mayo Clinic anesthesiologist earns APS's Walter B. Cannon Award 3Something's fishy in the tree of life 2'Black carbon' flowing from soil to oceans 2
... LAS-3000 imaging system combines new CCD ... interface, providing significantly improved system sensitivity ... The system is especially dedicated to ... system for Western blotting applications.,Fuiji's LAS-3000 ...
Capture faint-light images without losing sensitivity or resolution. With its brand new hardware and interface design, the LAS-1000plus turns sample imaging into a simple process....
... FLIM system combines the space and time dimensions ... of the optical microscope to open new horizons ... light source for excitation, the decay of a ... of the decay measured. Subtle changes in ...
...
Biology Products: