Navigation Links
Arena and Eisai Complete End-of-Review Meeting with FDA for Lorcaserin New Drug Application
Date:12/22/2010

SAN DIEGO and WOODCLIFF LAKE, N.J., Dec. 22, 2010 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA).

"The meeting discussions reinforce our position that we have a path forward to seek FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "Based on guidance we have received from the agency, we are executing several activities and expect to resubmit the lorcaserin NDA by the end of 2011. As we continue discussions with the FDA to refine elements of our plan, we may identify ways to shorten this timeline. We will provide more details about our plan on the conference call and webcast this morning."

Arena submitted an NDA for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues. The end-of-review meeting with the FDA included a discussion of the FDA's position on issues identified in the CRL and Arena's plan to respond.

Conference Call & Webcast Arena will host a conference call and webcast today, December 22, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss its plan to address the CRL and resubmit the lorcaserin NDA. The conference call may be accessed by dialing 877.643.7155 for domestic callers and 914.495.8552 for international callers. Please specify to the operator that you would like to join the "Lorcaserin" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days fol
'/>"/>

SOURCE Arena Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Arena Pharmaceuticals to Host Conference Call and Webcast to Provide Update Following Lorcaserin End-of-Review Meeting With FDA
2. Arena Pharmaceuticals Initiates Phase 1 Clinical Trial of APD811 for Pulmonary Arterial Hypertension
3. Arena Pharmaceuticals Announces Third Quarter 2010 Financial Results and Reviews Recent Developments
4. Arena Pharmaceuticals Provides Update on GPR119 Portfolio for Type 2 Diabetes
5. Endologix Announces Publication of Clinical Trial Results Supporting Anatomical Fixation with a Suprarenal Aortic Extension
6. Arena and Eisai Announce Upcoming Lorcaserin Presentations at Obesity 2010
7. Arena and Eisai Provide Update on Lorcaserin FDA Advisory Committee Meeting
8. Arena Pharmaceuticals to Host Conference Call and Webcast Following Lorcaserin FDA Advisory Committee Meeting
9. Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management
10. Published Data Demonstrate Arena Pharmaceuticals Lorcaserin Has Low Abuse Potential
11. Arena Pharmaceuticals Announces Third Quarter 2009 Financial Results and Recent Developments
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... Calif. , Dec, 22, 2014  Eiger ... Phase 2a study of lonafarnib in patients with ... was conducted at the National Institutes of Health ... .  The double-blinded, randomized, placebo-controlled, dose ascending ... twice daily and 200 mg twice daily for ...
(Date:12/19/2014)... TODAY, AEGATE, the leader in ... the appointment of Peter Fox as Chief ... and Partner Officer. Peter has served as ... acquisition by Oracle in 2011. Prior to ... and subsequently Convergys, a world renowned billing ...
(Date:12/19/2014)... 19, 2014   Hospira, Inc. (NYSE: ... drugs and infusion technologies, today announced that the company ... Conference on Wednesday, Jan. 14, 2015, in San ... begin at 10:30 a.m. Pacific time on Wednesday, Jan. ... parties through a live audiocast accessible via the Investor ...
Breaking Medicine Technology:Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 2Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 3Aegate Appoints new CTO and Chief Channels & Partner Officer 2Aegate Appoints new CTO and Chief Channels & Partner Officer 3Aegate Appoints new CTO and Chief Channels & Partner Officer 4
(Date:12/22/2014)... 22, 2014 The holidays are here, and ... season. Many may be thinking about how to enjoy these ... few weeks. Health Republic Insurance of New York has compiled ... Chernus, to provide some smart ideas to enjoy the holiday ... 1)    Avoid arriving at a holiday gathering over-hungry , Have a ...
(Date:12/22/2014)... Shanghai, China (PRWEB) December 22, 2014 ... for MabThera (rituximab) for the treatment of non-Hodgkin’s lymphoma ... Health , a leading global healthcare consulting firm. MabThera ... B-cell lymphoma (DLBCL), the most common form of NHL. ... Market Access and Barriers,” the incidence of NHL in ...
(Date:12/22/2014)... (PRWEB) December 22, 2014 Only weeks ... southern and mid-western cities to have a battery manufacturer ... TalkLocal ( http://www.talklocal.com ) is launching in Henderson ... economy. , “A strong manufacturing sector is going ... founder Gurpreet Singh explained, “and TalkLocal works with small ...
(Date:12/22/2014)... Pasadena sleep apnea dentist, Dr. Marine ... drivers are 15 times more likely to cause deadly ... experts believe that sleep-deprived drivers may be just as ... of Americans may be sleep-deprived without even knowing it. ... 18 million Americans have sleep apnea, but as many ...
(Date:12/22/2014)... Luxury Linen purveyor Peacock Alley ... to provide logistics and support for one of Dallas’ ... a long history of giving back to the community in ... year's Toy Drive were Whataburger® and 99.5 The Wolf. , ... holidays. Providing gifts to children who would otherwise not receive ...
Breaking Medicine News(10 mins):Health News:Health Republic Insurance of New York Offers Five Simple Tips to Eat Healthy During the Holidays 2Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 2Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 3Health News:TalkLocal Launches in Henderson Weeks Following New Megafactory, New Jobs Announcement 2Health News:Pasadena Dentist, Dr. Marine Martirosyan, Now Offers Consultations for Sleep Apnea 2Health News:Peacock Alley and Community Partners of Dallas Fulfill an Estimated 12,000 Holiday Wishes for Deserving Children 2
... Rao, an American scientist of Indian origin has been ... a new system which makes use of data for ... is the Senior Director of Engineering Research Development at ... ,Rao is reported to have contributed towards ...
... drinkers go in for wholesome and healthy food, beer drinkers ... also seen among// wine drinkers when compared to beer ... in Copenhagen have found that beer drinkers buy unhealthy food ... prefer wine, according to BBC News. ,Studying ...
... Jefferson and colleagues from Cochrane Collaboration (International private organization ... trials) reviewed data from over 50 clinical trials involving ... researchers found that the old drugs which were used ... some drugs like amantadine and rimantidine which were used ...
... employ people with Asperger's Syndrome, who suffer from difficulties ... total of 50,000 people who suffer from this disorder, ... //People who suffer from the Asperger's Syndrome have difficulty ... though the intelligence of those who suffer from this ...
... Researchers from McMaster University has reported in the Journal ... found that the scientists screened 480 strains of Streptomyces ... all the strains were multi-drug resistance //as they were ... antibiotics. ,The researchers were astonished by ...
... transmission case is due today in Harbin court today. The ... blood collected from an infected couple who sold their blood ... Northeast China. // It was found that 15 people were ... and the other four got infection indirectly from the infected, ...
Cached Medicine News:
... potent, naturally secreted estrogen and is the ... In the ovary, estradiol is produced from ... potent estrogen derived from androstenedione. Estrone and ... In men, small amounts of estradiol are ...
... ADV is a Microparticle ... the quantitative determination of ... human serum or plasma ... Troponin-I values are used ...
... most potent, naturally secreted estrogen and is ... [1]. In the ovary, estradiol is produced ... less potent estrogen derived from androstenedione. Estrone ... tissues. In men, small amounts of estradiol ...
The second-generation Dade Behring Acute Care Troponin I (cTnI) method is the first FDA cleared high sensitivity cTnI assay with the low-end precision necessary to meet the ESC/ACC guidelines (CV <10...
Medicine Products: