CAP in Medical Technology

More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL

Wyeth Withdraws European Application COLLEGEVILLE, Pa., April 23 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that it is withdrawing its application for an extension to the European Marketing Authorization for TYGACIL(R) ...

Cognition Therapeutics Closes Series A Financing to Advance Drug Candidates for Alzheimer's Disease

...thods is unique in the pharmaceutical industry. We're pleased to have Ogden cap and M5Invest join our other investors in supporting our pioneering approach...c and private companies. www.cogrx.com . About Ogden cap , LLC Ogden CAP, LLC is a New York company that has investments is a ...

Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections

...ce Broader safety window enabling potential longer course of therapy Possibility for expanded indications including bacteremia, severe cap and osteomyelitis Lower potential for drug-drug interactions including those with dietary tyramine, SSRIs and vasoconstrictors ...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)

...a did not demonstrate efficacy in the treatment of cap (3 positive, 11 negative, 1 abstaining). (Lo...therapeutic need for more effective treatments for cap and their interest in seeing the company pursue fu... About Community Acquired Pneumonia (CAP) cap is the sixth most common cause of death in the Uni...

Video: Partnership Unites UCB with Consumer Product Innovator OXO(R)

...inge steady using various grip positions. Easy to remove needle cover - rounded finger loop for easy removal of needle cover; flared needle cap designed to reduce needle pricks due to recoil. Easy to push syringe plunger - large and soft thumb pad for patients to push the plunger. ...

Midwest Research Institute Launches Clinical Molecular Diagnostics Laboratory

... Receives CLIA Certification and cap Accreditation PALM BAY, Fla., April 17 /PRNewswire-USNewswire/ -- To address the growing need for molecular diagnostics, officials at the Florida...

Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX

...hard Gentile, Northeastern Ohio University , Youngstown, Ohio "A Nd:YAG Laser with Sequential Emission of 1320nm and 1440nm Wavelengths with cap Technology is Effective in Neck Rejuvenation," Adriana Ribe, Natalie Ribe, Institut Natalie Ribe, Carceloa, Barcelona, Spain "Evaluation of ...

Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial

...of 200 patients in the randomized portion of the trial. Since then, the company has continued to enroll patients under CAPs, including the most recent cap approved by the FDA in mid-November allowing for enrollment of an additional 60 patients. As of October 24, 2008, the company had enrolled 607 patient...

Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia

...cacy of TYGACIL for the treatment of patients with cap with illness severe enough to require hospitalizat...nstipation. About Community-Acquired Pneumonia cap is defined as pneumonia acquired outside a hospita...ddition, hospitalization rates among patients with cap are approximately 20 percent. Symptoms of...

Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin

... in its regulatory strategy for cethromycin in the cap indication. To gain further insight into the evolv...ttee meeting discussing non-inferiority margins in cap clinical trials scheduled for April 1 and 2, 2008 ...8184. About Community Acquired Pneumonia (CAP) cap is the sixth most common cause of death in the Uni...

Replidyne Provides Strategic Update

...on (FDA), in which four Phase III clinical trials consisting of one placebo-controlled trial in each of ABS and AECB and two non-inferiority trials in cap would be adequate to submit a new drug application for faropenem covering the three indications. In November 2007, the FDA accepted Replidyne's specia...

Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia

... South Africa. "The need for new drugs to address cap is imperative, as bacterial resistance rates and a...is evidence of the potential value of this drug to cap patients." Approximately 5.6 million cases of cap are diagnosed each year in the United States, resu...

Paratek Pharmaceuticals Announces the Close of $40 Million Private Placement to Finance Programs to Combat MRSA Infections

...plete enrollment this December. Funding from the financing will allow for the completion of studies necessary to initiate Phase 3 studies in cSSSI and cap by mid-2008. The financing will also help Paratek continue development of a novel community-based broad-spectrum antibiotic that has been designed spe...

FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia

...nd levofloxacin - an existing treatment option for cap - cured 86.3 percent of studied patients. The most... Akron, Ohio. About Community-Acquired Pneumonia cap is defined as pneumonia not acquired in a hospital...cans each year. The cost of treating patients with cap is about $10 billion per year, with inpatient cost...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

...e a potent therapeutic option for the treatment of cap caused by Haemophilus influenzae. The following p...DA has not approved cethromycin as a treatment for cap or any other indication. About Advanced Life Scie...secondary clinical endpoints. Data from the second cap pivotal trial is expected to be reported in the Fa...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

...e a potent therapeutic option for the treatment of cap caused by Haemophilus influenzae. The following p...DA has not approved cethromycin as a treatment for cap or any other indication. About Advanced Life Scie...secondary clinical endpoints. Data from the second cap pivotal trial is expected to be reported in the Fa...

DEFLUX(R) Significantly Reduces Urinary Tract Infections in Children With Vesicoureteral Reflux

...t over 600 co-workers, with approximately 400 at the company's head office and production facility in Uppsala, Sweden. Q-Med AB is listed in the Large cap segment of the OMX Nordic Exchange in Stockholm. Q-Med Scandinavia Inc. markets DEFLUX(R), for the treatment of vesicoureteral reflux, VUR, (a malfor...

July Issue of Journal of Antimicrobial Chemotherapy Highlights Study of Factive Tablets for Five-Day Treatment of Community-Acquired Pneumonia

...and seven-day course of treatment with FACTIVE for cap formed the basis of the approval last month from t...ved in the U.S. for the five-day treatment of both cap and acute bacterial exacerbations of chronic bronc...ommunity-acquired pneumonia, as recommended in the cap treatment guidelines from the Infectious Diseases ...

Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial

...otocol clinical cure rate compared to Biaxin(R) in cap (cethromycin 91.5% (205/224) compared to Biaxin(R)...historical rate observed in any reported Biaxin(R) cap clinical trials to date. Cethromycin also achiev..., scientific forum. Program Design The Phase 3 cap clinical trial program is comprised of two randomi...

Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial

...to the projected timeline for announcement of top-line data from the second cap study, Trial CL-05. The Company is hosting a conference call and live web...e per protocol clinical cure rate compared to Biaxin(R) (clarithromycin) in cap (cethromycin 91.5% (205/224) compared to Biaxin(R) 95.9% (212/221) [-9.1, +...

Choosing Lab Quality Management Software

...ime pressures of managing and complying with accreditation requirements. Assessing the labs challenges The lab had previously undergone cap accreditation and was well aware of the additional demands that accreditation makes on staff time and resources. Connie Thurber, who led the accredita...