Navigation Links
Cempra Provides Guidance on the Clinical Program Required for Regulatory Approval for Solithromycin for Community-Acquired Bacterial Pneumonia (CABP)
Date:6/13/2013

CHAPEL HILL, N.C., June 13, 2013 /PRNewswire/ -- Cempra, Inc. (Nasdaq: CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infections, today described the steps expected for regulatory approval for solithromycin for community-acquired bacterial pneumonia (CABP).  This path forward is a result of a dialogue and End-of-Phase 2 meeting with the Food and Drug Administration (FDA).

"We believe our End-of-Phase 2 meeting with the FDA has provided us with clear direction toward approval of solithromycin for CABP," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra.  "We were pleased with the FDA input and believe we are in a position to proceed with our second Phase 3 study and the rest of the clinical program, subject to receipt of the necessary funding.  We know the requirements for the CABP safety database and efficacy endpoints for NDA submission. In addition, we received preliminary feedback on the trial design for the uncomplicated gonococcal infection indication."

The Phase 3 solithromycin clinical program in CABP will be planned to consist of an oral trial and an intravenous (IV)-to-oral clinical trial. Cempra followed the CABP guidance that the FDA proposed in a November, 2011, meeting of the Anti-Infective Drugs Advisory Committee. The FDA provided comments on the Phase 3 oral CABP protocol in June, 2012, and this global study is ongoing. This study compares five days of oral solithromycin with seven days of oral moxifloxacin. FDA responses prior to and at the End-of-Phase 2 meeting addressed the second Phase 3 study, which is the planned intravenous-to-oral step-down trial.

In the IV-to-oral Phase 3 study, approximately 800 patients with Port II to
'/>"/>

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

Page: 1 2 3 4

Related biology technology :

1. Cempra Presents Post-Phase 2 Analysis of Solithromycins Efficacy and Safety Results from Patients with Community Acquired Bacterial Pneumonia (CABP)
2. Cempra, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating Results
3. Cempra Inc. Presents Additional Data on the Clinical Profile and Activity Spectrum of Solithromycin at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
4. The Hemostemix Group of Companies Provides Corporate Strategy Update
5. Study led by GW professor provides better understanding of waters freezing behavior at nanoscale
6. Yongye International Provides Update on Status of Proposed Go Private Offer
7. Neuralstem Reports First Quarter Financial Results And Provides Business And Clinical Update
8. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of First Quarter 2013 Financials
9. Celsion Corporation Reports First Quarter 2013 Financial Results and Provides Business Update
10. Adamis Pharmaceuticals CEO Provides Update for Shareholders
11. Cellular Biomedicine Group Provides Update and 2013 Milestones
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... EvoDerma ’s NOOME Anti-Aging Motion has been upgraded ... with a second treatment cup to help prevent and smooth ... is thinner on the edges for a softer contact with ... uneven surfaces on the face, neck and décolleté. Choose to ... areas such as the cheeks and neck, or opt for ...
(Date:7/10/2014)... POINT, Ind. , July 10, 2014 ... expanded its use of capnography for respiratory ... growing group of healthcare leaders in embracing ... measures how effectively patients are breathing and ... depression occurs. By measuring the amount of ...
(Date:7/10/2014)... -- Kainos Capital, a firm specializing in acquiring and managing ... acquired the Slim-Fast brand from Unilever. Unilever will retain ... transaction were not disclosed. Slim-Fast is a ... ready-to-drink shakes, powders, bars and snacks to retail customers ... the United Kingdom and Ireland.  ...
(Date:7/10/2014)... , July 10, 2014 Research ... addition of the "International Photonic Integrated Circuit ... Forecasts to 2019" report to their offering. ... The concept of photonic integration traces its ... century. The promise of photonic integration went unexplored ...
Breaking Biology Technology:Introducing a New Bonus Treatment Cup for EvoDerma’s NOOME Anti-Aging Motion 2Franciscan St. Anthony Health-Crown Point Underscores Patient Safety Commitment Through Expanded Use of Capnography 2Kainos Capital Acquires Slim-Fast From Unilever 2International Photonic Integrated Circuit (Monolithic Integration, Hybrid Integration, Module Integration) Market - Forecasts to 2019 2
... and chief executive officer with Radiation Shield Technologies (RST), ... the Radiological Society of North America (RSNA) 94th Scientific ... a.m. to 5 p.m. Nov. 30 to Dec. 5 ... Dr., Chicago. North Building, Hall B. Booth No.: 9517. ...
... DNA Mini Portrait™ is this years, most unique must-have gift , ... ... of custom portraits made from the customers, DNA, launch DNA Mini Portraits™, ... and pop culture. DNA Minis are the most personal and unique ...
... Calif., and SEATTLE, Nov. 26 Spectrum,Pharmaceuticals, Inc. ... Inc.,(Nasdaq: CTIC )(MTA: CTIC) announced today ... 50/50 owned joint venture, RIT Oncology LLC, to ... States.,ZEVALIN, a radioimmunotherapeutic (RIT), is currently marketed in ...
Cached Biology Technology: New Radiation-Blocking Medical Garments Introduced at RSNA Meeting in Chicago : Demron-M Technology Provides Total Protection in a Lightweight, Durable, Flexible Fabric 2DNA 11, Creators of DNA Art, Introduces a More Affordable Line of Custom Portraits for this Year's Gift Giving Season 2Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 2Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 3Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 4Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 5Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 6Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 7Spectrum Pharmaceuticals and Cell Therapeutics to Jointly Market ZEVALIN, a Proprietary, Marketed Oncology Drug 8
(Date:7/10/2014)... -- Fingerprint Cards, (FPC,s) new mobile touch sensor ... Chinese Top 5 smartphone OEM has selected FPC1021 for a ... October 2014.   FPC is proud to announce ... has a planned date for the start of mass production ... phone of 3 million units. The Chinese OEM wants to ...
(Date:7/10/2014)... , July 9, 2014  Acuity Market Intelligence today released ... 2014 Edition" indicating that the global market for National Electronic ... 2013 to 2018. During this time, the number of National ... 3.5 billion. Asia , with its vast ... National eID cards issued, while Europe ...
(Date:7/10/2014)... for Basic Science (IBS), the main organization of the ... has announced that a group of researchers, led by ... in the field of optogenetics that can remotely control ... technology "OptoTrk" and it has succeeded with neuronal differentiation ... is that it requires only light to activate neuronal ...
Breaking Biology News(10 mins):FPC Wins DW for 1021 Touch Sensor for Flagship Smartphone from Chinese Top 5 Smartphone OEM 2National Electronic ID Programs Generate $54 Billion Between 2013 and 2018 with 3.5 Billion National eID Card Holders Worldwide 2New optogenetic tool for controlling neuronal signalling by blue light 2
... N.M. A matchbook-sized atomic clock 100 times smaller than ... researchers at Symmetricom Inc. Draper Laboratory and Sandia National Laboratories. ... 1.5 inches on a side and less than a half-inch ... its predecessors. Instead of 10 watts, it uses only 100 ...
... Aware, Inc. (NASDAQ: AWRE ), a leading supplier ... today announced that Edmund C. Reiter has resigned, effective April ... of the board of the company citing personal reasons.   ... General Counsel have been named co-CEOs and co-Presidents on an ...
... April 11, 2011 MiMedx Group, Inc. (OTCBB: MDXG), ... biomaterial-based products and bioimplants processed from human amniotic membrane, ... product, EpiFix™, a biologic implant specifically processed to offer ... options. The Company also announces the hiring of Frank ...
Cached Biology News:World's smallest atomic clock on sale 2World's smallest atomic clock on sale 3World's smallest atomic clock on sale 4Aware, Inc. Announces Resignation of Chief Executive Officer 2Aware, Inc. Announces Resignation of Chief Executive Officer 3MiMedx Group Announces Launch of EpiFix™ and Hiring of Vice President, Wound Care 2MiMedx Group Announces Launch of EpiFix™ and Hiring of Vice President, Wound Care 3MiMedx Group Announces Launch of EpiFix™ and Hiring of Vice President, Wound Care 4
... GC-rich nucleic acids ,The GC-RICH PCR ... and a proofreading polymerase, powers through templates ... with other polymerases and other blends of ... and the unique GC-RICH Resolution Solution combine ...
... Hot Start Taq ... activity before the onset ... nonspecific amplification and primer-dimer ... is raised, the antibody ...
B-FABP (FL-132)...
Roll of Mesh 5m x 25cm...
Biology Products: