Navigation Links
Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Date:1/24/2011

fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The increasing incidence of CDI, along with higher rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.

About FidaxomicinFidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of fidaxomicin eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, have been shown to disrupt the gut flora. Fidaxomicin facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence rates. Optimer has filed applications in the U.S. and the EU for marketing authorization for fidaxomicin for the treatment of CDI and reducing risk of recurrence when used for treatment of initial CDI.

About Optimer PharmaceuticalsOptimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin).  Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI).  The Company has submitted an NDA to the FDA, and filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being deve
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin
2. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
3. Data From Optimers Second Phase 3 Study of Prulifloxacin Presented at Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
4. Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI)
5. Optimer Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
6. Optimer Pharmaceuticals to Present at the 28th Annual J.P. Morgan Healthcare Conference
7. Optimer Pharmaceuticals Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency
8. Optimer Pharmaceuticals to Present at September 2010 Investor Conferences
9. Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting
10. Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
11. Optimer Pharmaceuticals to Host Investor and Analyst Event on November 18
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... 2014  The management team at Columbia Laboratories, ... a conference call on July 31, 2014, to ... June 30, 2014.  The call details are as ... am EDTDial-in numbers: , Toll free: (877) 870-4263 ... & archive): , www.columbialabs.com , under ,Investor, ...
(Date:7/23/2014)...  Silk Road Medical, Inc., a developer of ... and extra-cranial cerebrovascular disease, announced today the appointment ... position of Chief Technology Officer.  In this new ... Development efforts across its family of transcarotid access ... joining Silk Road Medical, Michael was the Vice ...
(Date:7/23/2014)... July 23, 2014  Dompe, a leader in R&D for ... that rhNGF (Recombinant Human Nerve Growth Factor) has been designated ... Administration (FDA). The candidate drug, developed by ... drug for the treatment of neurotrophic keratitis, a degenerative corneal ... and is currently without a cure. This is the ...
Breaking Medicine Technology:Columbia Laboratories to Discuss Second Quarter 2014 Financial Results on July 31st Conference Call 2Silk Road Medical Appoints Ground Breaking Innovator as Chief Technology Officer 2Silk Road Medical Appoints Ground Breaking Innovator as Chief Technology Officer 3Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis 2Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis 3Dompe announces the Food and Drug Administration (FDA) has granted orphan drug designation to its rhNGF-based treatment for neurotrophic keratitis 4
... N.C., July 27 Timothy Mastro,MD, FACP, DTM&H, ... 1st,as Senior Director of Research, will share information ... prevention at the,International AIDS Conference in Mexico City., ... Planned Trials," will examine ongoing and upcoming clinical ...
... BIRMINGHAM, Ala., July 28 BioCryst,Pharmaceuticals, Inc. (Nasdaq: ... Phase II study of intravenous (i.v.) peramivir administered ... for the treatment of seasonal,influenza. The trial, conducted ... met its primary endpoint of improvement in the ...
Cached Medicine Technology:HIV Prevention Expert Dr. Timothy Mastro Speaks on Future of Pre-Exposure Prophylaxis at International AIDS Conference 2BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting 2BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting 3BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting 4BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting 5
(Date:7/23/2014)... July 23, 2014 (HealthDay News) -- Regularly checking the ... stroke, researchers report. "Screening pulse is the method ... over age 65 who have never had a stroke. ... noninvasive and easy way to identify people who might ... said study author Dr. Bernd Kallmunzer, of Erlangen University ...
(Date:7/23/2014)... Officials from China,s Northwest Agricultural and Forestry University in ... signed a memorandum of agreement that lays the groundwork ... Safety in China. , The signing ceremony was held ... between high-level officials of the U.S. Department of Agriculture ... agreement is a landmark event for UC Davis and ...
(Date:7/23/2014)... Coral, FL (PRWEB) July 23, 2014 Rich ... announce the success of their charity yard sale to support ... was raised and 100% of the proceeds will be donated ... at the event are being donated to the Habitat for ... Fort Myers, Florida 33903. , One of the highlights ...
(Date:7/23/2014)... 23, 2014 Global Cardio Care, Inc., ... External Counterpulsation (EECP), is celebrating the 100th birthday ... at the health center. , Weber has been ... receiving ongoing EECP therapy since 1999, he no longer ... CEO of Global Cardio Care, introduced the Sara ...
(Date:7/23/2014)... 23, 2014 Bodybuilding.com, the Internet’s most-visited ... of nutritional supplements, has officially opened the polls for ... , the fastest growing sports nutrition company, is up ... of the Year, Best Tasting Protein of the Year- ... of the year - Whey-HD™, Pre-workout Supplement of the ...
Breaking Medicine News(10 mins):Health News:Routine Pulse Check May Prevent Second Stroke, Study Says 2Health News:Global food safety research agreement signed by China and UC Davis 2Health News:Global food safety research agreement signed by China and UC Davis 3Health News:Rich Dad Education Charity Yard Sale Raises Over $650 for Habitat for Humanity of Lee and Hendry Counties 2Health News:Global Cardio Care Celebrates EECP Patient’s 100th Birthday 2Health News:Vote Now; BPI SPORTS is Nominated for Eight 2014 Bodybuilding.com Supplement Awards 2Health News:Vote Now; BPI SPORTS is Nominated for Eight 2014 Bodybuilding.com Supplement Awards 3
... born children can also lead normal lives in a ... the McMaster University’s Saroj Saigal. Where educational achievements are ... who were born prematurely, and those with a normal ... greater risk of problems in behavior and academic achievement. ...
... a person was used as a basis to judge the ... report published in the Journal of the American Medical Association. ... that of their Indian and White compatriots, where HIV and ... said to have been implemented by the South African National ...
... failure following use of the drug aprotinin, marketed as ... the drug in heart surgery patients.// The clotting drug ... undergoing cardiac surgery. ,It has now been ... were twice as likely to develop kidney failure and ...
... Global Health Program, founded by Bill and Melinda Gates, ... Executive Director, according to the Gates foundation Release. Dr ... GlaxoSmithKline, will now lead the program. ,Yamada’s key ... while also working on enhancing the availability of drugs ...
... of Medical Research, Sydney have expressed hope over their ... rheumatoid arthritis. //It is also claimed to improve the ... attack, sepsis, psoriasis and post transplant recipients. ... models (mice) and promising results have been obtained. It ...
... unscientific fears, according to a skier who is on a ... a report which states that second hand smoke (SHS) does ... smokers consider the measures as attempts by the powerful antismoking ... ,The Utah Legislature is bei9ng called upon to counter ...
Cached Medicine News:Health News:Safety Of Heart Drug Questioned 2
... The only portable 36/70 static/kinetic/multi-color perimeter that ... room and costs only slightly more than ... perimeter,The Centerfield automatically performs static and kinetic ... to 70 with a fixation shift. Offers ...
... Wavefront Analyzer provides the practitioner with ... analysis system on the market today! ... auto refractometer, auto keratometer, and a ... benefits of wavefront measurement!, ,The KR-9000PW ...
The new TOPCON 8800 Series of auto refractors and auto kerato-refractors satisfies the needs of today's demanding eyecare practice !...
The new TOPCON 8800 Series of auto refractors and auto kerato-refractors satisfies the needs of today's demanding eyecare practice !...
Medicine Products: