Navigation Links
Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
Date:11/20/2008

REINACH, Switzerland, November 20 /PRNewswire-FirstCall/ -- Arpida (SWX: ARPN) announced today that the Anti-infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 17 to 2 against the approval of intravenous iclaprim, an antibiotic currently in development for the treatment of patients with complicated skin and skin structure infections (cSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

Arpida remains confident in the efficacy and safety of intravenous iclaprim and its potential in combating serious resistant infections. Iclaprim has been tested against both vancomycin and linezolid, and in combined Phase III studies that included nearly 1,000 patients with cSSSI, iclaprim has been shown to have high cure rates, exceeding 90 percent in the Per-Protocol population. Iclaprim has demonstrated potent bactericidal (killing) activity against MRSA and an extended range of resistant pathogens, with a well tolerated side-effect profile. Arpida is fully committed to iclaprim's development and will continue to work with the FDA to address any questions related to iclaprim in anticipation of the drug's Prescription Drug User Fee Act (PDUFA) goal date of January 16, 2009.

In addition to the FDA regulatory application, the European Medicines Agency (EMEA) accepted intravenous iclaprim for review August 2008. In September 2008, Arpida filed a New Drug Submission for intravenous iclaprim in Canada.

Arpida continues to study the potential of iclaprim, including investigation of an oral formulation. In early 2008, Arpida received FDA approval to conduct a Phase II iclaprim 'intravenous-to-oral' switch trial in patients with cSSSI. Patient enrolment was completed in September 2008 and results are expected in December 2008.

Additional studies are ongoing worldwide to investigate the use of intravenous iclaprim in hospital-acqui
'/>"/>

SOURCE Arpida Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Arpida Invited to Present Data on Iclaprim at Scientific Conference
2. Arpida Provides Further Comments on the Pivotal Phase III Trials
3. Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
4. Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
5. Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
6. Pivotal Phase III Data Confirm the Efficacy and Safety of Arpidas Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections
7. GeoVax Labs, Inc. Comments on Discontinuance of Mercks HIV Vaccine Trial
8. Pediatric Pulmonary Expert Comments on Study of Lung Transplants for Cystic Fibrosis
9. SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes
10. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
11. Replidyne to Participate on Anti-infective Panel at RBC Capital Markets Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... PITTSBURGH , July 30, 2014   ... Markets Groups Inc.: OTC Pink: UPZS), a Delaware ... a distribution agreement with Larasan Pharmaceutical Corporation ("Larasan"), a ... products.  According to the agreement, US-based Larasan will ... gourmet 6" frozen pizza through Larasan,s vast distribution ...
(Date:7/30/2014)... TARRYTOWN, N.Y. and PARIS ... REGN ) and Sanofi (EURONEXT: SAN and ... new Phase 3 ODYSSEY trials of alirocumab in people ... greater percent reduction from baseline in low-density lipoprotein cholesterol ... comparator.  Alirocumab is an investigational monoclonal antibody targeting PCSK9 ...
(Date:7/30/2014)... -- Packaging Coordinators, Inc. (PCI) is pleased to announce it ... Services Limited (Penn Pharma). Penn Pharma is headquartered in Tredegar, ... United Kingdom and operates regional offices in ... Tokyo , Japan. Penn Pharma offers both drug ... form manufacturing, as well as Clinical Packaging, Labeling, and ...
Breaking Medicine Technology:Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 2Unique Pizza and Subs Announces Asian Distribution Agreement with Larasan Pharmaceutical Corporation 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 2Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 3Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 4Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 5Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 6Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 7Regeneron and Sanofi Report Positive Top-Line Results from Nine Phase 3 Trials of Alirocumab in People with Hypercholesterolemia 8PCI Announces Definitive Agreement to Acquire Penn Pharma 2PCI Announces Definitive Agreement to Acquire Penn Pharma 3PCI Announces Definitive Agreement to Acquire Penn Pharma 4PCI Announces Definitive Agreement to Acquire Penn Pharma 5
... imaging,(BSGI) is effective in the detection of cancers not ... study presented today at the annual meeting of,the Radiological ... "BSGI can identify the most difficult ... F. Brem, M.D., professor of,radiology and director of the ...
... Horizon Therapeutics, Inc., a,privately held biopharmaceutical ... 3 trials evaluating its lead investigational ... HZT-501, a novel, proprietary fixed-dose,combination product ... significant reduction in the incidence of ...
Cached Medicine Technology:New Breast Imaging Technology Targets Hard-to-Detect Cancers 2New Breast Imaging Technology Targets Hard-to-Detect Cancers 3Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints 2Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints 3Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints 4
(Date:7/30/2014)... WEDNESDAY, July 30, 2014 (HealthDay News) -- For patients ... is enough to trigger airway inflammation for at least ... just what you smell, but also what you think ... Monell Chemical Senses Center in Philadelphia, said in a ... about scents and fragrances. When we expect that an ...
(Date:7/30/2014)... jockeying for supremacy within a cancerous tumor, the most ... fastest, researchers at Dana-Farber Cancer Institute report in a ... journal Nature . The findings have important ... the study authors explained: Doctors need to ascertain which ... metastasis and select drugs that target the critical genes ...
(Date:7/30/2014)... 2014 On July 29, 2014, Freedom ... Institute of Public Health, Gandhinagar released a new report ... II: The Way Forward .” The report was released ... and Practices to Improve Nutrition Security in New Delhi, ... the Green Revolution" and chair of the Coalition ...
(Date:7/30/2014)... 2014 Shabaikai is an ambitious historical ... the Pomo Indians located on the shores of Russian ... Shabaikai, meaning ‘crooked snake’. Clarkson takes the reader into ... violence of prohibition and organized crime, providing a glimpse ... the most powerful men in the world convene the ...
(Date:7/30/2014)... (PRWEB) July 30, 2014 With the recent ... Ground Zero, the Ground Zero Museum Workshop in the Meatpacking ... bookings. Says the Museum Workshop's Carole Barnes, "We have had ... all the major travel sites who sell us so tourists ... crystal clear as to what we do and what the ...
Breaking Medicine News(10 mins):Health News:Even Thinking an Odor is Harmful May Spur Asthma Symptoms 2Health News:Target growth-driving cells within tumors, not fastest-proliferating cells 2Health News:Target growth-driving cells within tumors, not fastest-proliferating cells 3Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 2Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 3Health News:New Report on Integrated Health and Microfinance in India Shows the Way Forward 4Health News:Bill E. Clarkson Releases Debut Fact-Based Novel, Shabaikai 2Health News:Despite Some Confusion over 9/11 Memorial Opening, Kid-Friendly Ground Zero Museum Workshop on 14th Street Continues It's Mission 2Health News:Despite Some Confusion over 9/11 Memorial Opening, Kid-Friendly Ground Zero Museum Workshop on 14th Street Continues It's Mission 3Health News:Despite Some Confusion over 9/11 Memorial Opening, Kid-Friendly Ground Zero Museum Workshop on 14th Street Continues It's Mission 4Health News:Despite Some Confusion over 9/11 Memorial Opening, Kid-Friendly Ground Zero Museum Workshop on 14th Street Continues It's Mission 5
... the second day of Sedation Dentistry Safety Week, the spotlight ... team members throughout the United States who help ensure that ... comfortable and anxiety-free. "Safety is very much an all-team responsibility," ... and one of the world,s leading sedation dentistry educators. ...
... the reader,s choice award for Westlake village and East Ventura County in ... caring local business represented in the newspaper. , ... Westlake Village, CA ... Khanna the reader,s choice award for Westlake village and East Ventura ...
... Diamond Mothers Day Card for Breast Cancer Campaign,Hallmark Cards ... designed by Strictly Come Dancing host, Tess Daly, to support its ... donate £1/4 million to two breast cancer charities. , ... ...
... given financial incentives to improve the quality of ... of changes important to advancing quality, according to ... adopted by medical groups include speeding up adoption ... more closely tracking the improvement of physician performance ...
... Invention Machine , a leading provider of ... by Blue Highway LLC to help transform ... in medical diagnostics. A Welch Allyn company, ... software to accelerate and sustain product innovation, deliver ...
... MOUNTAIN VIEW, Calif., March 9 Alexza Pharmaceuticals, Inc. ... corporate presentation will be webcast live during the Cowen ... 17, 2008 at 4:40 p.m. Eastern Time. The ... Place. To access the live presentation via the ...
Cached Medicine News:Health News:Sedation Dentistry Safety Week Spotlights the Important Role of Dental Team Members 2Health News:Sedation Dentistry Safety Week Spotlights the Important Role of Dental Team Members 3Health News:Ventura County Star Newspaper Honors Khanna Institute 2Health News:Tess Daly Supports Hallmark's Breast Cancer Campaign 2Health News:Tess Daly Supports Hallmark's Breast Cancer Campaign 3Health News:Study finds pay for performance stimulates changes in medical practice 2Health News:Study finds pay for performance stimulates changes in medical practice 3Health News:Blue Highway Selects Invention Machine Goldfire to Fuel Product Pipeline and Sustain Breakthrough Innovation 2Health News:Blue Highway Selects Invention Machine Goldfire to Fuel Product Pipeline and Sustain Breakthrough Innovation 3Health News:Alexza's Corporate Presentation to be Webcast at the Cowen & Company 29th Annual Health Care Conference 2Health News:Alexza's Corporate Presentation to be Webcast at the Cowen & Company 29th Annual Health Care Conference 3
... Focus multichannel pipettes speed ... reagents into microplates, with ... l volumes. The improved ... Focus multichannels, combined with ...
... rows, and microplatesthat is the area of ... becoming an ever-increasing force. Ergonomics (reduced weight ... reason that the Multichannel Research model was ... provides effective, precise, and rapid processing of ...
... Hall, the aortic and mitral valves are distinctly ... the disc opens to 75 to maximize forward ... to minimize regurgitation. Designed to rotate within its ... the leading edge of the disc parallel to ...
Inquire...
Medicine Products: