Navigation Links
Alimera Sciences Reports Third Quarter 2013 Financial Results
Date:11/11/2013

at the benefits of ILUVIEN did not outweigh its risks. The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee (Advisory Committee) may be of assistance in addressing these deficiencies and providing advice whether a patient population can be identified in which the benefits of ILUVIEN might outweigh its risks. Alimera was notified by the FDA, shortly after the issuance of the CRL, of the scheduling of a January 2014 meeting of the Advisory Committee. In a subsequent communication with the FDA, Alimera believes it clarified that the purpose of the Advisory Committee meeting is to consider the benefits and risks of ILUVIEN based on existing data available from Alimera's FAME™ Study. Alimera believes that if this were a positive meeting, it could lead to further discussions with the FDA regarding the potential approvability of the NDA.

In the CRL, the FDA also referenced deficiencies in the methods and controls used for the drug product at the facility where ILUVIEN is manufactured. Alimera does not believe that these deficiencies will affect its European commercial supply. Alimera and its third-party manufacturer are in the process of resolving these deficiencies.

"We look forward to the Advisory Committee meeting in January 2014 where we, together with retinal physicians, can discuss the benefits and risks of ILUVIEN in a public forum," said Mr. Myers.

Third Quarter 2013 Financial Results Total revenue for the third quarter of 2013 was $758,000, compared to total revenue of $179,000 for the second quarter of 2013, the quarter in which ILUVIEN was launched commercially in Germany and the United Kingdom.

Research and development expenses for the third quarter of 2013 decreased to $1.8 million, compared to $2.2 million for the third quarter of 2012. The decrease was primarily attributable to decreases of $320,000 in costs related to the completion of the enrollment of the physician utilizati
'/>"/>

SOURCE Alimera Sciences, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Alimera Sciences to Release Third Quarter 2013 Results and Provide Update on Upcoming FDA Advisory Committee Meeting
2. Alimera Sciences Reports Second Quarter 2013 Financial Results
3. Alimera Sciences to Release Second Quarter Fiscal Year 2013 Financial Results
4. Alimera Sciences Reports First Quarter 2013 Financial Results
5. Alimera Sciences Secures $20 Million Debt Facility
6. Alimera Sciences To Release First Quarter Fiscal Year 2013 Financial Results
7. Alimera Sciences Reports Fourth Quarter 2012 Financial Results
8. Alimera Sciences To Release Fourth Quarter And Fiscal Year 2012 Financial Results
9. Alimera Sciences Participating in Credit Suisse London One-on-One Healthcare Conference
10. Alimera Sciences Names European Management Team
11. Alimera Sciences To Present At Credit Suisse 2012 Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... Calif. , July 30, 2015 Edwards Lifesciences ... science of heart valves and hemodynamic monitoring, today announced that ... Board of Directors. "Bob is an ardent champion ... a true privilege to have him on Edwards, board as ... Mussallem , Edwards, chairman and CEO.  "Bob has provided a ...
(Date:7/30/2015)... 2015  ResMed Inc. (NYSE: RMD ) today ...  Revenue for the quarter was $453.1 million, a 9 ... 2014 (a 17 percent increase on a constant currency ... quarter ended June 30, 2014.  Diluted earnings per share ... ended June 30, 2014.  The results ...
(Date:7/30/2015)...  Unichem Pharmaceuticals ( USA ), Inc. ... 25 mg 1000-count bottle to the consumer level. This ... to the identification of a Clopidogrel tablet found in ... risk associated with mistakenly taking a Clopidogrel tablet instead ... experiencing Clopidogrel,s side effects which include bleeding and/or bruising. ...
Breaking Medicine Technology:ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 2ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 3ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 4ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 5ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 6ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 7ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 8ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 9ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 10ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 11ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 12ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 13ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 14ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 15ResMed Inc. Announces Results for the Fourth Quarter and Fiscal Year 2015 16Unichem Pharmaceuticals (USA), Inc. Issues a Voluntary Nationwide Recall of Hydrochlorothiazide Tablets Due to the Potential Presence of Foreign Tablets 2
... from the "NEXT" Study Also Showed Arzoxifene Significantly ... Women with OsteoporosisATHENS, Greece, March 23 Eli ... presented new data showing arzoxifene, an investigational selective ... at increasing bone mineral density (BMD) in the ...
... TBI TrialCOSTA MESA, Calif., March 19 Oxygen Biotherapeutics, ... company has received a letter from the FDA that ... a basis to resume clinical studies of Oxycyte(R) in ... carrier.The letter was in response to the company,s request ...
Cached Medicine Technology:Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis 2Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis 3Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis 4Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis 5Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A. 2Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A. 3
(Date:7/31/2015)... , ... August 01, 2015 , ... The Honor Society ... Advisory Panel on the Future of Nursing (GAPFON) 20-21 July 2015 in San Juan, ... participate in this meeting. , Dr. Silvia Cassiani, Advisor, Nursing and Allied Health Personnel ...
(Date:7/31/2015)... ... July 31, 2015 , ... Recently touted by Becker’s ... predictive health analytics , Jvion continues to disrupt the predictive analytic and big ... targets patient and population level illness to drive prevention and better health outcomes. ...
(Date:7/31/2015)... ... , ... There’s no better way to enjoy the summer weather than by ... next meal, making July the most appropriate to be National Hot Dog Month. King ... Make the next cookout different than the ones in the past. Celebrate National Hot ...
(Date:7/31/2015)... ... 31, 2015 , ... M3 USA MDLinx.com, source of the Smartest Doc Board ... Courses. , The additions of Gastroenterology, Pulmonology and Allergy/Immunology round out an already ... for the exam easy and painless. MDLinx offers thousands of board-exam style questions ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... Well-known for ... now offering wedding cakes with custom designs, making life just a little ... beautifully designed wedding cakes for each customer who orders one. , The bakery provides ...
Breaking Medicine News(10 mins):Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 2Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 3Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 4Health News:Jvion Showcased as Leader in the Predictive Analytic Market 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 2Health News:King Kullen Honors National Hot Dog and Blueberry Month 3Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 2Health News:MDLinx Offers Three New Board Exam Prep Courses - Gastroenterology, Pulmonology and Allergy/Immunology 3Health News:Pastry Palace of Las Vegas Announces It Is Now Offering Custom Wedding Cakes in Las Vegas 2
... mimic sounds and now researchers have used ,virtual mates, to ... on a mate. The research, published in Ethology , ... ,calls,. Parrots are among the few species of ... mimic new sounds, but the evolutionary reason for this ability ...
... a single rock being overturned or an entire mountaintop ... processes, and vice versa. Ecological scientists will discuss findings ... growth to the diversity of insect species on green ... buildingsat the Ecological Society of America,s 95th Annual Meeting ...
... tools for simultaneous tumor imaging and treatment, because of ... cells. In mice, researchers from Emory University School of ... to implanted brain tumors, while enhancing tumor visibility via ... online by the journal Cancer Research . ...
... Reinberg HealthDay Reporter , MONDAY, Aug. 2 ... time on the Internet run the risk of developing ... 1990s, uncontrolled or unreasonable Internet use has been identified ... researchers say. Pathological Internet use has been linked with ...
... Dotinga HealthDay Reporter , MONDAY, Aug. 2 (HealthDay ... partly inherited, a new study reveals that close relatives of ... are much more likely than those of other people to ... families with autism," said study co-author John A. Sweeney. "These ...
... symbol of courage and sacrifice, of sin and sexuality, of ... the color red makes men more alluring to women. ... found men more appealing when they were either pictured wearing ... finding is reported in the August issue of the ...
Cached Medicine News:Health News:'Virtual mates' reveal role of romance in parrot calls 2Health News:Scientists unravel human-ecosystem interactions 2Health News:Scientists unravel human-ecosystem interactions 3Health News:Scientists unravel human-ecosystem interactions 4Health News:Iron oxide nanoparticles becoming tools for brain tumor imaging and treatment 2Health News: Addictive Internet Use Tied to Depression in Teens 2Health News: Addictive Internet Use Tied to Depression in Teens 3Health News:Vision Abnormality Seen in Close Relatives of Autism Patients 2Health News:Women more attracted to men in red 2
For vacuum-driven processing of spin columns; Reduced sample handling and accelerated processing; Parallel sample processing using QIAGEN spin columns; Easy cleaning of internal components by simpl...
Inquire...
... allows processing of up to 24 spin columns in ... columns into and out of a centrifuge. The ... savings rapid vacuum-driven purification and cleanup of ... Convenience minimal hands-on-time ...
... Caliper provide an automated alternative to Kuderna-Danish, Rotary, Vacuum-Style and Nitrogen Blow-Down Evaporators. For over ten years ... ... ... ...
Medicine Products: