Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

NEW YORK, Aug. 3 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathw...

Prostate Cancer Active Surveillance Protocol Clinical Trial Conducted by NorthShore University HealthSystem

Prostate Cancer Patients See Benefit to Program Evanston, IL (Vocus) June 15, 2009 -- Prostate cancer is the second leading cause of cancer deaths in American men. Every three minutes, a man in the United States is diagnosed with prostate cancer, and every 20 minutes ...

Innovative Oxidative Stress Management Protocol Safely and Effectively Enhances Body's Primary Antioxidant

OSCEOLA, Wis., June 11 /PRNewswire/ -- NeuroScience, Inc. has launched an antioxidant protocol that combines an objective assessment of glutathione levels along with unique antioxidant compounds, including OSR#1, CysNAC, and NeuroVitamins. These products are capable of eliminating free radicals in...

Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)

LA JOLLA, Calif., June 2 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug for the ...

Hard to Treat Diseases (HTDS) clinical trial protocol for MMR Vaccine expected Q2 2009

SHENZEN, China, March 27 /PRNewswire-FirstCall/ - Hard to Treat Diseases (HTDS) www.htdsmedical.com Today after the market closed the company announced the clinical trial protocol for their MMR Vaccine is under preparation, and is expected to be approved by the end of the second quarter 2009. ...

Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer

EXTON, Pa., March 23 /PRNewswire/ -- Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced today that the U.S. Food and Drug Administration (FDA) has agreed to and approved the design of a single, pivotal, Phase III clinical trial evaluating farletuzumab (also known a...

Cordex Pharma Submits to the FDA an Amended Special Protocol Assessment for ATPace

LA JOLLA, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that it has submitted to the U.S. Food and Drug Administration (FDA) an amended Phase 3 protocol for ATPace to be reviewed as a Special Protocol Assessment (SPA). The amendment addres...

Dr. Blair Keagy Launches MPAnalytics, Inc. Medical Consultant Group : MPAnalytics, a Medical Consultant Group, Provides Market Analysis and Guidance for New Medical Devices, Technology, and Clinical Trial Protocol

Blair Keagy, MD, CEO, is pleased to announce the launch of MPAnalytics, Inc. - a medical consultant group dedicated to helping businesses evaluate the commercial potential of new medical products and technologies. CHAPEL HILL, N.C. (Business Wire EON) November 17, 2008...

Duska Therapeutics Receives Comments From FDA on Phase 3 ATPace(TM) Protocol Synopsis

LA JOLLA, Calif., Aug. 12 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has received comments from the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products on a synopsis of a proposed Pha...

MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine

MOUNTAIN VIEW, Calif., Jan. 16 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ), an emerging pharmaceutical company, today announced that it has completed the special protocol assessment (SPA) process with the U.S. Food and Drug Administration (FDA) for the first Phase 3 cl...

FDA Approves the Opening of a Phase II Registration Protocol Using REXIN-G(R) for Osteosarcoma in California U.S.A.

SAN MARINO, Calif., Nov. 5 /PRNewswire/ -- Epeius Biotechnologies Corporation announced today that the company has taken a major step toward the commercialization of its lead product with the opening of a Phase II Registration Protocol using Rexin-G for osteosarcoma in the United States. Follo...

CNS Response, Inc. Modifies rEEG(SM) Trial Protocol for 'Treatment-Resistant Depression' Study

COSTA MESA, Calif., Oct. 25 /PRNewswire-FirstCall/ -- CNS Response, Inc. (OTC Bulletin Board: CNSO) announced today that it has conducted a quality assurance analysis of its current multi-center trial of rEEGSM -guided pharmacotherapy for individuals with treatment-resistant depression. Based ...

Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077

CONSHOHOCKEN, PA and VANCOUVER, BC, Oct. 15 /PRNewswire/ - Neuromed Pharmaceuticals, a biopharmaceutical company developing new and improved chronic pain drugs, announced today it has successfully reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol ...

Susan G. Komen for the Cure(R)'s Founder, Nancy G. Brinker, Reengages With Organization Following Tenure as U.S. Chief of Protocol

Return to Private Life Increases Volunteer Time to World's Largest Breast Cancer Organization Founded in Her Sister's Memory WASHINGTON, March 9 /PRNewswire/ -- Nancy G. Brinker ignited the global breast cancer movement 29 years ago by promising her sister, Susan G. Komen, who died at age 36...

Supratek Pharma Inc. announced today that under the Special Protocol

Assessment (SPA) process, it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal study protocol for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract MONTREAL, Nov. 28 /P...

Susan G. Komen for the Cure Founder Sworn in as Chief of Protocol

Nancy G. Brinker, Leader of the Global Breast Cancer Movement, Takes on New Role at Dept. of State WASHINGTON, Oct. 10 /PRNewswire-USNewswire/ -- The ceremonial swearing-in of Ambassador Nancy G. Brinker, founder of Susan G. Komen for the Cure, the world's largest breast ...

President George W. Bush Appoints Susan G. Komen for the Cure Founder as Chief of Protocol

Nancy G. Brinker, Leader of the Global Breast Cancer Movement, Takes New Public Role DALLAS, Sept. 14 /PRNewswire/ -- The appointment of Ambassador Nancy G. Brinker, founder of Susan G. Komen for the Cure, the world's largest breast cancer organization, as Chief of...

Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer

Napo Pharmaceuticals, Inc., which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners , today announced that under the Special Protocol Assessment (SPA) process it has obtained agreement with the United Stat...

BioCryst Receives Special Protocol Assessment for Fodosine

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the FDA's Special Protocol Assessment (SPA) process for the design of its planned pivotal clinical trial of the oral formulation of the company's le...

New Protocol Targets Aggressive Brain Cancer

After 20 years in the U.S. Marine Corps, 50-year-old Joseph Wollschlager Jr. felt invincible. Until one day at work when what looked like a seizure// led to the diagnosis of a life-threatening brain tumor. Survival rates for this type of cancer are usually less than a year. But Wollschlager i...

New Screening Protocol Identifies More Case Of Lynch Syndrome

A new way to select patients for further testing may increase detection of Lynch syndrome, a disorder that predisposes people to developing colorectal cancer at a young age, //researchers report in the Feb. 21 issue of the Journal of the National Cancer Institute. Lynch syndrome, also known a...

New data from NIH lab confirms protocol to reverse type 1 diabetes in mice

New data published in the Nov. 24 issue of Science supports the protocol to reverse type 1 diabetes in mice and there is proof now that adult precursor cells// from the spleen can add to the renewal of beta cells. In 2001 and 2003, researchers at Massachusetts General Hospital (MGH) showed the bene...

Low Dose Anti Rejection Protocol Helps Intestinal Transplant Recipients

Rakesh Sindhi, a surgeon and a researcher at the children hospital of Pittsburgh is planning to present how the new low dose anti rejection protocol //has appreciably improved the outcomes of the intestinal transplant recipients. Research performed by Rakesh Sindhi, MD, Co-Director of Pediatric...

GeoVax Labs, Inc. Announces Six Month 2009 Financial Results and Provides Operational Update

...al path for this project has a much shorter duration than our current program for the development of a preventative vaccine. We have already commenced protocol development for our first Phase 1 human clinical trials investigating the therapeutic vaccine approach. Our reassessment of the time required to gain...

CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

...oll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of th...

Arena Pharmaceuticals Announces Second Quarter 2009 Financial Results and Recent Developments

... maintain their weight loss as compared to those on placebo. 66.4% of lorcaserin patients who completed one year of treatment according to the trial's protocol lost at least 5% of their weight and the average weight loss in this responder population was 26 pounds. Treatment with lorcaserin also resulted in hi...

QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy

...e vaginal maturation index, changes in vaginal pH (all p<0.001) and improvements in the most bothersome symptom of vaginal dryness (p=0.01 on a per protocol analysis). All women were supplied with a non-hormonal vaginal lubricant to be applied as needed during the treatment period and the study results dem...

Kaiser Permanente Approves $11 Million in Community Benefit Grants

...rst joint effort to establish a uniform patient safety program to the nation's public hospitals. The initial goal is to establish quality improvement protocol and procedures at 80 public hospitals nationwide, of which 30 will be named later this year. Equipping Health Care Professionals With Tools an...

Millennium Pharmaceuticals Inc./Lymphoma Research Foundation funds lymphoma research

... is to prepare clinicians to design and administer clinical studies in lymphoma and to take on the primary responsibilities for clinical trial design, protocol writing, Institutional Review Board (IRB) submission, and publication. Dr. Fu will be pursuing a Career Development Plan with the guidance of his me...

Neusoft Medical's Latest Innovation, NeuViz 16 CT Scanner, Approved by FDA for the U.S. Market

...gher spatial resolution during scanning and creates more detailed 3D/MPR images. The product also features DoseRight Modulation as well as a pediatric protocol to ensure optimized dose without compromising image quality. One of the core technologies of CT is embedded software, which determines the qual...

Study aims to induce recovery from ankylosing spondylitis

...rldwide Cochrane Collaboration in evidence-based medicine. The treatment protocol is based on a molecular understanding of the interaction of intracellular a...se trials are aimed at moving the molecular discovery known as the Marshall protocol as quickly as possible from bench to bedside. Data from the initial A...

Newly Patented Sterilization/Disinfection Method Reduces Risk of Microorganism Growth on Hard Surfaces

...A pioneered the use of this patented steam as a hard surface disinfection protocol (TANCS®), and is the licensee for this application. The protocol is suitable for a wide range of cleaning and disinfection issues not readil...

MO BIO Laboratories, Inc. Launches PowerFood(TM) Microbial DNA Isolation Kit

... from food cultured microorganisms. The PowerFood Microbial DNA Isolation Kit stands out from other commercial food kits with its easy-to-use protocol that allows for isolation of DNA from a variety of gram + and gram - food pathogens. Further, it is the only complete kit on the market, eliminating ...

Colonoscopy Beats 'Camera Pill' at Catching Colon Cancer

...s the potential to encourage more patients to get screened for colon cancer, Van Gossum said. In time, "technological improvements, as well as adapted protocol for colon preparation, could increase the sensitivity of this new method," he noted. Dr. Felice Schnoll-Sussman, director of research with the Jay ...

Statement for Attribution to Andy Braner, President, Kanakuk Colorado, Bayfield CO

...th. "In addition, we will continue to be vigilant in our efforts to detect and isolate any campers with flu-like systems. Our influenza protocol at Kanakuk Colorado includes: immediate isolation of campers with flu-like symptoms, personal care and screening by physicians and nurses, and parenta...

Nurses File Cal-OSHA Complaint After Hospital Refuses to Supply Swine Flu Masks for Units with Infected Patients

...ess for infection control purposes. Compounding these problems, some rooms with infected patients lack appropriate HEPA filters, and proper isolation protocol is not being followed, with visitors moving in and out of contact with infected patients. "Nurses will be on the front line of the fight agai...

Peregrine Pharmaceuticals Reports Financial Results for Fiscal Year 2009

...rminates its contract prior to completion, the risk that the company does not receive all of its funding under the DTRA contract, the risk that future protocol submissions may not be approved and the risk that the company may not be able to monetize any of its assets. It is important to note that the company'...

Coronary Calcium Scans Can Raise Cancer Risks

...ngle CAC scan would be, and found an enormous variation. There is no single protocol -- set of rules -- for such a scan, which can be done on a variety of equip...in 1990, and CT scanner technology has changed, so it is not clear what the protocol might be," he noted. The study found roughly a 14-fold difference in rad...

Study Suggests Preseason Shoulder Strength May Determine Injury Severity for Baseball Pitchers

...r a five-year period (2001-2005). Over the course of the five-year period, 144 major and minor league baseball pitchers were analyzed using a specific protocol by a single athletic trainer. Prone internal rotation (IR), prone external rotation (PER), seated external rotation (SER) and supraspinatus (SS) stren...

Caltech chemists say antibody surrogates are just a 'click' away

...he new work, Heath and his colleagues, including Caltech graduate student Heather D. Agnew, the first author on the Angewandte paper, have developed a protocol to quickly and cheaply make such highly stable compounds, which are composed of short chains of amino acids, or peptides. "I actually traveled to Chic...