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Project Zero Delay Accelerates Drug's Path to Clinical Trial

HOUSTON and WILMINGTON, Del., Aug. 3 /PRNewswire-FirstCall/ -- A phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes three to six...

Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.

Company Expands Overseas TBI Trial COSTA MESA, Calif., March 19 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received a letter from the FDA that outlines what the agency termed a "path forward" as a basis to resume clin...

New PRO2000 HIV-Prevention Findings Important Milestone on Path Toward Development of Effective Vaginal Microbicide

Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides, issued the following statement on the results of the Phase II/IIb safety and effectiveness study of BufferGel and PRO2000 (0.5 percent concentration): SILVER SPRING, Md., Feb. 9 /PRNewswire/ -- The Microbicide Trials N...

Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval

SAN MATEO, Calif., Sept. 24 /PRNewswire/ -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure....

ActivBiotics Outlines a Clinical Path Forward to Examine if Rifalazil Is Superior to Azithromycin in the Treatment of Chlamydia STD

WELLESLEY HILLS, Mass., Feb. 19 /PRNewswire/ -- Joseph F. Finn, Jr., CPA, the Assignee for the Benefit of Creditors of ActivBiotics, announced today the design of a clinical trial to investigate whether Chlamydia STD is treated adequately by currently approved antibiotics. Rifalazil, the most ...

New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

ROCKVILLE, Md., May 2, 2007-The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs " report identifying many of the unanswered scientific questions th...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

...ll. "In addition to reporting data from the first of our Phase 3 trials for mipomersen, we and Genzyme refined and communicated the regulatory path for mipomersen in the United States and Europe. While the strategy continues to evolve, Genzyme plans to file the first NDA for mipomersen in the U.S...

Economy is Driving Many Osteoporotic Women to Retire Later - But Their Ability to Work May Be Undermined by Sub-Optimal Management of Their Disease

...ne and puts women at higher risk for fractures or broken bones.(19) About the Know My Bones Council Guided by the belief that the path to optimal bone health can be found through educating and empowering women to more actively manage their disease, six leading women's advocacy groups ...

Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen International Consensus Meeting on the Primary Treatment of Early Breast Cancer

...etrix GeneChip(R) 3000Dx2 (GCS3000Dx2) system. The MapQuant(TM) Dx testing solution for routine micro-array profiling of breast tumors also includes a path Kit, CE-marked, ensuring easy sampling, RNA-preservation and sample shipping at room Temperature, and a CE-compliant software, ensuring highly reliabl...

St. Francis Surgeon Uses Tissue Regeneration Technology to Rebuild Patients' Heart Structures

...ported Gerdisch, who is co-director of the St. Francis Midwest Heart Valve Center . "Then, in March 2008, we performed the first enlargement of the path blood follows as it exits the heart using the CorMatrix ECM, in lieu of a prosthetic device, for a patient undergoing valve surgery. The first m...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

...um oxybate to the U.S. Food and Drug Administration (FDA) by the end of 2009. UCB will consult with the European Medicines Agency (EMEA) to define the path forward. UCB has the exclusive marketing and distribution rights to sodium oxybate for fibromyalgia in Europe and some other countries outside North A...

Alfacell Provides Shareholder Update

... that may confirm Dr. Pass' in vitro study. After much thought, consideration, and input from highly respected lung experts, we have decided our path moving forward would be to conduct a clinical trial in non small cell lung cancer (NSCLC) in patients who have become resistant to platinum therapy. D...

Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs

...g. According to Jill Jarecki, Ph.D., Research Director FSMA, "This meeting will be an exciting milestone for the project, and an essential step in the path towards human clinical trials of the drug candidate." Motor Neuron Replacement Program: California Stem Cell (CSC) is preparing for a final FDA...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... Dr. Schaber continued, "This feedback, in conjunction with the SPA agreement, clearly validates the direction of the orBec(R) clinical development path that has the potential to lead to regulatory approval of orBec(R) in both the US and the European Union. We are excited to move forward with this tri...

CardioVascularCS.Org, a division of EndoVascular Forum, Inc., Partners with Complex Interventional Cardiovascular Therapy (CICT) to Extend Electronic Medical Care Advancement

...ence, and clinical development in which the massive integration of experiences and observations in and of themselves form a complementary, accelerated path to knowledge generation and dissemination. "The end goal of this partnership is to expand and to extend the essential link that exists between physici...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

...l patient population. We look forward to reviewing these results with FDA and their European and Japanese counterparts before determining the forward path for this promising drug." NTI-0302 NTI-0302, a Phase III randomized, double-blind study comparing XERECEPT(R) to dexamethasone for the contro...

Spirus Medical Announces Complete Examinations of the Small Intestine by Physicians Using Endo-Ease(TM)

...e examination of the small intestine has been elusive in regular practice due to the difficulty in maneuvering an endoscope through the long, tortuous path in the body. The small intestine is about 20 to 23 feet long and other methods for reaching and studying its full length, whether starting through th...

Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II Trial for Cocaine Addiction

...caine addiction, which still represents a significant unmet medical need. We will carefully study the results of our trial and assess the appropriate path for conducting future clinical trials evaluating CPP-109 for the treatment of cocaine addiction. We also expect to have the results of our methampheta...

Mayo Researchers Help Discover Genetic Cause for Primary Biliary Cirrhosis

... ROCHESTER, Minn., May 27 /PRNewswire-USNewswire/ -- Researchers have discovered a novel molecular path that predisposes patients to develop primary biliary cirrhosis , a disease that mainly affects women and slowly destroys their livers. Primary bili...

Blanchette Rockefeller Neurosciences Institute and Inverness Medical Innovations to Develop Commercial Test to Detect Early Alzheimer's Disease

...ing to accurately diagnose Alzheimer's disease, but I believe we are on the path to realizing a test that will take the guess work out of proper treatment,"...eller Neuroscience Institute (BRNI) is to cure Alzheimer's disease, and the path to a cure begins with detecting the disease early," said Senator Jay Rockef...

Celladon Corporation Announces Presentation of First-in-Human Gene Transfer to Treat Heart Failure at the 12th Annual Meeting of the American Society of Gene Therapy

... that recombinant adeno-associated viral vectors (AAV) are ideal for restoring SERCA2a enzyme production by means of cardiac muscle gene transfer. The path of investigation for MYDICAR(R) (AAV1/SERCA2a), from rodent studies to the ongoing Phase II clinical trial, has yielded valuable insights for the enti...

Swine Flu (H1N1) Infectivity to Increase Markedly and Lethality to Remain Low According to Latest Replikin* Peptide Genomic Data

...fluenza vaccine, which is now ready for testing. It used the same approach to produce a peptide H5N1 (avian flu) vaccine that successfully blocked low path H5N1. It has not previously been possible to correlate virus structures with a virus outbreak or cessation of outbreak, let alone to predict six to 12...

PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA

...tting our regulatory plan to FDA by May 21st, well ahead of the June 15th submission deadline. We feel we have presented a comprehensive and credible path for the ultimate licensure of SparVax(TM). We continue to maintain an ongoing dialogue with FDA, and anticipate an expeditious review of our developm...

Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials

...Director, Alzheimer's disease research for Eli Lilly and Company. "Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer's disease." EXPEDITION will be conducted in Argentina, Brazil, Canada, Japa...

Novel Vaccine Approach Offers Hope in Fight Against HIV

... team may have broken the stubborn impasse that has frustrated the invention of an effective HIV vaccine, by using an approach that bypasses the usual path followed by vaccine developers. By using gene transfer technology that produces molecules that block infection, the scientists protected monkeys from ...

Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

...ns Development Company ( www.msdrx.com ), based in Kalamazoo, Mich., is developing innovative therapeutics using a different pharmacological path to treat type 2 diabetes . This new approach seeks to improve the efficacy of treatment by freeing patients from the adverse side effects of current ...

Progress Against Malaria and Other Infectious Diseases Among Highlights at Annual Vaccine Conference

...ed to be used together," he said. The RTS,S vaccine, developed by GlaxoSmithKline Biologicals with support from the Malaria Vaccine Initiative of path (Program for Appropriate Technology in Health), is the first of 70 experimental malaria vaccines, most in early pre-clinical testing, to move into a P...

Micromet Presents Update on BiTE Antibody Pipeline and Reviews Key AACR Presentations at R&D Day

...ficant areas of development across Micromet's BiTE antibody platform and included updates on: BiTE antibody Blinatumomab -- a rapid path to market has been identified for Acute Lymphoblastic Leukemia (ALL) with a registration trial planned to begin in 2010. Dose escalation continues in ...

Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin

...-based company Sanaria Inc., with support from the path Malaria Vaccine Initiative (MVI), has initiated a ...h Program, the Institute for One World Health, the path Malaria Vaccine Initiative, and the University of...he ability to commercialize the vaccine. The path Malaria Vaccine Initiative (MVI) is a global prog...

Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae Vaccine

...ll's Streptococcus pneumoniae vaccine supported by path VIENNA, April 7 /PRNewswire/ -- Intercell AG ...ne to prevent pneumococcal disease is supported by path - a U.S.-based non-profit organization that create...orted the preclinical studies of the IC47 vaccine, path has now committed another USD 3.6 m for the furthe...

Landmark Study in The New England Journal of Medicine Shows HPV Testing Significantly Reduces Deaths from Cervical Cancer, Compared to other Methods Including Pap

...d pilot cervical cancer screen-and-treat projects. To ensure that HPV testing can reach women in all regions of the world, QIAGEN is working with path and the Bill & Melinda Gates Foundation to develop a new version of its state-of-the-art HPV test -- to be called the care HPV test -- for public...

Oh, My Aching Back: Give Me a Shot of Ozone

...There are millions of people with back pain who suffer and who can't work because of their pain. Undergoing invasive surgical diskectomy puts you on a path where you may be left with too little disk. Taking out a protruding disk may lose the shock absorption that naturally resides between them in the spin...

Savient Provides Update on Pegloticase BLA

...t the primary endpoints demonstrating that the drug works as compared to the effects of placebo, the every 2 week dose regimen presents a much clearer path toward FDA approval due to the significant medically and clinically relevant benefit demonstrated as early as week 13 in the randomized clinical trial...

ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium

...n the ability to demonstrate a positive effect on signs in the environment and on symptoms in the controlled environment chamber, there is now a clear path forward to Phase III studies and New Drug Application filing for this product. Background on ISTA's Recent Phase IIb Study Results ISTA's Ph...

Kyowa Hakko Kirin Announces Development Policy for Anti-Parkinson's Disease Drug KW-6002 (Istradefylline)

...wait the results of the ongoing Japanese phase 2b study of KW-6002 as adjunctive therapy to Levodopa, and then comprehensively examine and determine a path forward for KW-6002. The results of the Phase 2b study in Japan have recently become available and demonstrate the efficacy of KW-6002 compared w...

MannKind Reports Successful Completion of Device Bioequivalence Trial

...inst a range of measures. Together with the recent announcement that we met the primary end-points of our pivotal Phase 3 program, we now have a clear path to submission of the AFRESA NDA. With study 138 complete, there are no longer any outstanding elements of the NDA and we expect to have the complete N...

Two New Studies in the New England Journal of Medicine Show Malaria Vaccine Candidate Advancing in Africa

...he MVI. About RTS,S/AS GSK and the path Malaria Vaccine Initiative signed a public-private...rom the Bill & Melinda Gates Foundation to the path Malaria Vaccine Initiative. GSK has invested appro... to six diseases in one vaccine. About the path Malaria Vaccine Initiative (MVI) The...

Isogen Retains Strategic Partner Sheridan Road Financial to Meet Global Biopharma Demand

...s complex needs. As a result, Isogen is the best positioned company on the market to address these unmet needs. Sheridan Road Financial will provide a path by which Isogen can ramp follow-on funding to expand its presence in the biopharma industry. "Isogen will help our customers address major ind...

Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings

...tentially serious adverse events. As a next step, we have plans to meet with the clinical review team at the FDA to reach an agreement on the clinical path forward," said Dr. Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "Menerba provides a true paradigm shift in the treat...

PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.

...ercialization efforts in Europe, under the CE Mark we received in late 2007. Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard(TM) in the U.S., and with its receipt, we are well-positioned to begin the trial with our targeted study sites, ...
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