Navigation Links
Major advance in UCB pipeline: positive topline Phase 3 results for brivaracetam in epilepsy patients with partial-onset seizures
Date:7/23/2014

t program has involved over 3,000 people and offers over eight years of clinical experience with some patients.1 We look forward to discussing the data with the regulatory authorities and the scientific community."

Based on the results of the brivaracetam Phase 3 program, UCB plans to submit a New Drug Application to the US Food & Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2015.

This Phase 3 study was a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared to placebo, over a 12-week treatment period, in 768 randomized focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs.2,7 The primary endpoint for the European regulatory authorities is the 50% responder rate for partial-onset seizure frequency compared with placebo, over the treatment period standardized to a 28-day duration. The primary endpoint for the FDA is the percent reduction over placebo for partial-onset seizure frequency, over the treatment period standardized to a 28-day duration.2 Detailed data from this study will be submitted for presentation at upcoming epilepsy congresses and for publications in peer-reviewed journals.

About brivaracetam and the Phase 3 clinical development program Discovered and developed by UCB, brivaracetam is a highly selective synaptic vesicle protein 2A ligand.8,9

The phase 3 clinical development plan for brivaracetam consisted of the following studies:N01252: an evaluation of the efficacy and safety/tolerability of adjunctive brivaracetam 20, 50, and 100 mg/day compared with placebo over 12 weeks, in 399 randomized patients (greater than or equal to 16 to 70 yea
'/>"/>

SOURCE UCB
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Majority of Biotech/Pharma Employees Poised to Job Hunt
2. ZenCash Plucks Top Executives from Major DFW Brands
3. Accelerated Cure Project for Multiple Sclerosis Approved for Major Funding Award from Patient-Centered Outcomes Research Institute to Create MS Patient-Powered Research Network
4. Clinovo Rolls Out Major Enhancements for Open Source EDC ClinCapture at Outsourcing in Clinical Trials West Coast Conference
5. Verified Clinical Trials Stops Dual Enrollment in Clinical Trials in Major CNS Clinical Trials to Reduce Potential Adverse Events and Improve Data Quality
6. Major CRO Gives Top Ratings To Verified Clinical Trials To Stop Dual Enrollment In Clinical Trials On Late Phase Trial
7. Kibow Biotech Achieves Major Victory with Indias IPAB Decision to Uphold 2009 Product Patent
8. Sales Momentum Introduces 5 Payoffs to Asking Questions in Sales Calls in a White Paper - Mastering Major Account Selling
9. Dyadic International To Present At Two Major Conferences In December 2013
10. Sales Momentum Shares Three Common Pitfalls to Avoid When Developing Major Account Sales Strategies
11. The Blazing Diamond and the Quantum Jewel: Two Major Discoveries in Quick Succession
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/2/2015)... , March 2, 2015 VLP ... -based biotechnology company focusing on the research and ... generation antibody agents based upon a novel and ... 2015 Life Sciences Impact Grant Award from the ... grant, created by MCDED, is awarded to life ...
(Date:3/2/2015)... Calif. , March 2, 2015  Asterias Biotherapeutics, ... the emerging field of regenerative medicine, today announced that ... financial and operating results on Tuesday, March 10, 2015 ... Company will host a conference call and webcast on ... 1:30 p.m. Pacific to discuss the results and recent ...
(Date:3/1/2015)... March 01, 2015 Market Publishers ... for quality market research promotion on Internet. MarketPublishers.com ... reports worked out by DataGroup Booksellers. , Natalie ... Publishers Ltd, commented on the recent partnership agreement ... Booksellers in our team of publishers. Since 1974, ...
(Date:2/27/2015)... Mass. , Feb. 27, 2015 ... of the NCATS rare-diseases portfolio " in ... a new financing technique to reduce the risk ... diseases and potentially unlock new levels of funding ... The product of a unique collaboration between scientists ...
Breaking Biology Technology:VLP Therapeutics Wins the 2015 Life Sciences Impact Grant Award from the Montgomery County Department of Economic Development 2Asterias Biotherapeutics to Report Fourth Quarter and Full Year 2014 Results on March 10, 2015 2Market Publishers Ltd and DataGroup Booksellers Sign Partnership Agreement 2Market Publishers Ltd and DataGroup Booksellers Sign Partnership Agreement 3New Financing Technique May Hold Key to Unlocking Funding for Rare Diseases 2New Financing Technique May Hold Key to Unlocking Funding for Rare Diseases 3New Financing Technique May Hold Key to Unlocking Funding for Rare Diseases 4
... , , , , , , For transfection ... Features and benefits , , , , , , ... siRNA for effective gene silencing , Quick and easy setup , ... of RNase activity , , , , , ...
... , , , , , , For automated purification of genomic and mitochondrial ... , Format: , ... 8), QIAamp DNA Blood MDX Protocol, , ... Fresh or frozen whole blood (with common anticoagulants , such ...
... For , HotStarTaq DNA Polymerase , HotStarTaq Master Mix Kit , ... , Kit Contents , ... Technical Assistance , Safety Information , ... , HotStarTaq DNA Polymerase , ...
Cached Biology Technology:TransMessenger Transfection Reagent 2TransMessenger Transfection Reagent 3QIAamp DNA Blood BioRobot MDx Kit 2HotStarTaq PCR Handbook 2HotStarTaq PCR Handbook 3HotStarTaq PCR Handbook 4HotStarTaq PCR Handbook 5HotStarTaq PCR Handbook 6HotStarTaq PCR Handbook 7HotStarTaq PCR Handbook 8HotStarTaq PCR Handbook 9HotStarTaq PCR Handbook 10HotStarTaq PCR Handbook 11HotStarTaq PCR Handbook 12HotStarTaq PCR Handbook 13HotStarTaq PCR Handbook 14HotStarTaq PCR Handbook 15HotStarTaq PCR Handbook 16HotStarTaq PCR Handbook 17HotStarTaq PCR Handbook 18HotStarTaq PCR Handbook 19HotStarTaq PCR Handbook 20HotStarTaq PCR Handbook 21HotStarTaq PCR Handbook 22HotStarTaq PCR Handbook 23HotStarTaq PCR Handbook 24HotStarTaq PCR Handbook 25HotStarTaq PCR Handbook 26HotStarTaq PCR Handbook 27HotStarTaq PCR Handbook 28HotStarTaq PCR Handbook 29HotStarTaq PCR Handbook 30HotStarTaq PCR Handbook 31HotStarTaq PCR Handbook 32HotStarTaq PCR Handbook 33
(Date:1/22/2015)... 2015 Valid S.A. ("Company") (BM&FBOVESPA: VLID3 ON), is pleased ... State of Washington,s Department of Licensing, ... and central issuance system for driver,s licenses and identification cards ... planning and development will start in January 2015, with enrollment ...
(Date:1/22/2015)... DETROIT , Jan. 13, 2015 Technology Showcase, Hall ... iris-based identity authentication solutions, today announced it will showcase its ... and developed by the Department of Energy,s Oak Ridge ... International Auto Show . EyeLock,s iris identity authentication technology is ...
(Date:1/22/2015)... NXT-ID, Inc. (NASDAQ: NXTD and NXTDW) a biometric authentication ... success of the Wocket™ smart wallet at CES 2015 in ... as one of the "11 Hot Products at CES" in a review ... So Far" by Newseveryday.com and "The top 10 gadgets from CES 2015" ...
Breaking Biology News(10 mins):Valid USA Signs Contract For Washington Driver's License Issuance 2EyeLock Debuts First Iris Authentication Technology Embedded in 3D Printed Automobile 2EyeLock Debuts First Iris Authentication Technology Embedded in 3D Printed Automobile 3CES Response for NXT-ID's Wocket Smart Wallet Kicks Off 2015 2CES Response for NXT-ID's Wocket Smart Wallet Kicks Off 2015 3
... of newborns, blood samples stored in a Michigan bio-bank, ... practice of using the blood spots for medical research. ... public policy decisions and develop an improved consent process ... said Ann Mongoven, an assistant professor in MSU,s Center ...
... squids as different as they may look, they ... the phylum Mollusca , also called molluscs. An ... Professor Ken Halanych, USA, with the participation of Johannes ... into the relationships among different molluscs as part of ...
... 2011 SynCardia Systems, Inc. ( www.syncardia.com ), manufacturer ... announced today that University Hospital of Nantes successfully transplanted ... days of support. Mrs. Mouche is a French gypsy ... 40 km from Nantes. "We first implanted ...
Cached Biology News:MSU engages public on using newborn blood spots for research 2Research into molluscan phylogeny reveals deep animal relationship of snails and mussels 2Research into molluscan phylogeny reveals deep animal relationship of snails and mussels 3SynCardia's Total Artificial Heart Rescues LVAD Patient with Right Ventricular Failure 2SynCardia's Total Artificial Heart Rescues LVAD Patient with Right Ventricular Failure 3
ABgene® supplies a 94kDa ultra-pure recombinant thermostable DNA polymerase obtained by high level expression of the Taq DNA polymerase gene in E. coli....
Heavy-duty rim. Especially recommended as a titration flask. Corning5100. capacity 250 mL Special grade: student grade...
... This CLS number ... number, created to easily ... If showing no availability ... the old Sigma-Aldrich number ...
A convenience pack containing one each of the most popular sizes of Cat. No. 4980 flask. Designed for the low volume user, a case contains one each of five sizes: 50mL, 125mL, 250mL, 500mL, and 1L....
Biology Products: