Navigation Links
Alimera Sciences Reports Second Quarter 2014 Financial Results
Date:8/7/2014

We continue to have strong relationships with contract sales organizations in other EU countries, and as we expand to other markets we will implement contract, direct or hybrid sales models depending on the unique characteristics of that market."

"We continue to make strong progress in our geographic expansion efforts and remain on track to launch ILUVIEN in Portugal and France during the fourth quarter of 2014. In June 2014, the Italian Medicines Agency granted marketing authorization to ILUVIEN. We also received a positive outcome of the Repeat-Use Procedure for ILUVIEN in 10 additional EU countries, and we are working closely with these countries during the national phase to obtain ILUVIEN marketing authorization in each one. Recently, Norway and Denmark became the first countries to grant national marketing authorization following the positive outcome in June of the Repeat-Use Procedure application."

As announced in April 2014, Alimera's resubmission of its new drug application (NDA) for ILUVIEN to the U.S. Food and Drug Administration (FDA) to address questions raised in the FDA's October 2013 complete response letter has been acknowledged by the FDA as a complete class 2 response and a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 had been established. In the October 2013 complete response letter, the FDA referenced deficiencies in the methods and controls used for the drug product at the third party facility where ILUVIEN is manufactured. In July 2014, the third party facility received a notification from the Los Angeles District of the Department of Health and Human Services (LA District) after their pre-approval and good manufacturing practice inspection of the facility in connection with Alimera's NDA. In that notification, the LA District recommended approval of the NDA by the FDA. This is only a recommendation which the FDA is not obligated to follow. Only the FDA can issue an official approval of the NDA.

Se
'/>"/>

SOURCE Alimera Sciences, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

Related biology technology :

1. Sangamo BioSciences Announces Presentation At The 2014 Wedbush Securities Life Sciences Management Access Conference
2. Ardelyx to Present at the Wedbush 2014 Life Sciences Management Access Conference
3. Neural ID Enables Auditing and Analysis of Biosignal Data Directly from the TIBCO Spotfire® Powerful Data Visualization Platform for PerkinElmer’s Life Sciences Customers
4. Sequenom, Inc. Announces Participation At The 2014 Wedbush Securities Life Sciences Management Access Conference
5. Applied DNA Sciences to Host Conference Call Tuesday August 12, 2014
6. iBIO Institutes PROPEL Center Awards Grants for AdvaMed 2014 to Early-Stage Life Sciences Companies
7. Rancho BioSciences, in Partnership with Omicsoft, have Integrated Array Suite with tranSMART
8. Dr. Michael E. Hogan, Ph.D., Joins Applied DNA Sciences as Vice President, Life Sciences
9. Epic Sciences Appoints Greg Lucier as Chairman of the Board of Directors
10. U.S. Environmental Protection Agency (EPA) Awards Vala Sciences a Second ToxCast Contract
11. Proove Biosciences Exhibits Industry Leading Data and Research at International Spine Intervention Society’s 22nd Annual Scientific Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... 23, 2015 Portal Solutions , a ... on Microsoft Office 365 and SharePoint platforms , today ... program for being one of the region’s fastest-growing mid-sized companies ... growth. , “To be recognized a second year in ...
(Date:1/22/2015)... 22, 2015 GEA Niro Soavi the ... laboratory homogenizer, the PandaPLUS 2000, which is ideal for ... and cell disruption . This compact laboratory homogenizer ... juices, liquid food, food additives and ingredients as well ...
(Date:1/22/2015)... RI (PRWEB) January 22, 2015 Protocol ... , The growing team of brand-neutral, independent consultants, Protocol ... Philip Rogers explained that over the years, his company ... , Moroso, Town of Plainfield, as well as others. ...
(Date:1/22/2015)... January 22, 2015 Dr. Greg Leyer of ... annual Scripps Natural Supplements Pre-Conference seminar on probiotics in San ... an annual continuing education conference for health care professionals. This ... the topic of probiotics in health. Dr. Leyer spoke about ...
Breaking Biology Technology:Washington SmartCEO Announces Portal Solutions as 2015 Future 50 Award Winner Second Year in a Row 2Washington SmartCEO Announces Portal Solutions as 2015 Future 50 Award Winner Second Year in a Row 3GEA Niro Soavi Announces the PandaPLUS 2000 Homogenizer for Processing New Applications for Nanoemulsions and Cell Disruption 2Protocol Networks Brings Independent Technology Consulting to the Constitution State 2
... of the month, declining reimbursement, rates may force ... patients with limited access to care when they need it ... boomers approach,retirement age, a confluence of forces may threaten access ... joint disorders., A near-epidemic level of bone and joint ...
... Leading a trend of unprecedented,growth in biotechnology innovation, ... traction in the past year in,terms of development ... released,today at the 2008 BIO International Convention in ... support the need to measure,innovation in the market, ...
... Energetiq Technology, Inc., a,developer and manufacturer of specialized ... a revolutionary,technology that enables light sources to achieve ... spectral range. The LDLS(TM) Laser-Driven,Light Source is embodied ... series of,user-friendly compact light products that can be ...
Cached Biology Technology:A Perfect Storm Threatens Patient Access to Specialty Medical Care 2A Perfect Storm Threatens Patient Access to Specialty Medical Care 3In a Year of Unprecedented Growth for Biotechnology Innovation, Targeted Therapies Gain Most Significant Traction, According to New Deloitte Study 2In a Year of Unprecedented Growth for Biotechnology Innovation, Targeted Therapies Gain Most Significant Traction, According to New Deloitte Study 3In a Year of Unprecedented Growth for Biotechnology Innovation, Targeted Therapies Gain Most Significant Traction, According to New Deloitte Study 4In a Year of Unprecedented Growth for Biotechnology Innovation, Targeted Therapies Gain Most Significant Traction, According to New Deloitte Study 5Energetiq's Laser-Driven Light Source Technology Enables Continuous Spectrum Light Sources, from Visible to Deep Ultraviolet 2
(Date:1/22/2015)... , January 22, 2015 , ... year  The European Patent Office to present a video ... British nominations to be featured: Christofer Toumazou and ... former finalists and winners of the Award   Starting ...
(Date:12/24/2014)... Dec. 23, 2014  Since its launch in December 2014, the ... the pain of trying to remember their usernames and passwords ... to their smartphones. To assist people who have struggled to ... that created 1U and focuses on redefining identity, announced today ...
(Date:12/19/2014)... , Dec. 18, 2014 Research and Markets ... the "iPhone 5S Fingerprint Sensor - Apple/AuthenTec TMDR92 ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... Apple introduced the fingerprint reading feature with the iPhone ...
Breaking Biology News(10 mins):Ten Years of the European Inventor Award: A Retrospective Look at the Inventors and Ideas That Have Changed Our Lives 2Ten Years of the European Inventor Award: A Retrospective Look at the Inventors and Ideas That Have Changed Our Lives 31U Offers Best Solution to the Username / Password Dilemma: For FREE! 21U Offers Best Solution to the Username / Password Dilemma: For FREE! 3iPhone 5S Fingerprint Sensor - Apple/AuthenTec TMDR92 & Sapphire - Technology Report 2
... key to the blinding effects of diabetic retinopathy is ... Georgia researchers said. Interleukin-6, known to contribute ... helps ignite inflammation of the retina, a first step ... blindness is working-age adults, MCG researchers reported online in ...
... of dollars each year on exotic smelling perfumes and lotions ... a new study in Psychological Science , a journal ... be the best way to capture a potential mate,s attention. ... habits: Animal studies have shown that male testosterone levels are ...
... Malaga have created the ,Inventory of Daily Stressors, a ... physical appearance, taking part in numerous extracurricular activities and ... that increase the risk of suffering from childhood stress. ... to assess daily stress amongst schoolchildren", Mara Victoria Trianes, ...
Cached Biology News:Discovery points toward anti-inflammation treatment for blinding disease 2A new method to measure childhood stress 2
... Design with Purpose -- ... MS provide the highest level ... performance in an affordable, easy-to-use ... autosampler and workstation guarantees success ...
EnzChek cellulase substrate *blue fluorescent, 339/452...
Homo sapiens 4-aminobutyrate aminotransferase Antigen: Recombinant Protein...
... sizing single-stranded RNA ranging from 0.5 kb to 10 ... consists of nine bands in even increments (0.5 1 ... to simplify size estimation. The 1.5 kb band is ... and identification of RNA bands on the gel. All ...
Biology Products: