fast in Medical Technology

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... (NDA) for velaglucerase alfa allowed under the fast Track process. "We are very pleased with ... 30, 2009, three weeks after Shire received fast Track designation. fast Track designation allows a company to file ...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

... alfa (talactoferrin) has been granted fast Track designation by the U.S. Food and Drug ... with sunitinib (Sutent(R) - Pfizer). The fast Track program is designed to expedite the review ... diseases where there is an unmet medical need. fast Track designations allow a company to file a New ...

AdvanDx Launches Fast, 90 Minutes Protocol for All CE-IVD Marked PNA FISH(R) Tests in Europe

... CE-IVD marked PNA FISH(R) tests in Europe. The fast protocol reduces the PNA FISH turn-around time ... directly from positive blood cultures fast and actionable results for 95-99% of all patients ... AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... until the end of the studies (Week 24 in fast 4WARD; Week 52 in RAPID 1). "The data show that ... evaluate the effects of CIMZIA over two years. fast 4WARD (Study 011) In the 24-week fast 4WARD (eFficAcy and Safety of cerTolizumab pegol ...

AdvanDx Submits Yeast Traffic Light PNA FISH(TM) for FDA 510(k) Clearance for Detection of Candida species in Positive Blood Cultures

... molecular diagnostic products that provide fast results for these serious infections," said Thais ... AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic ... technician and maintenance time, while providing fast results without sacrificing accuracy. Major ...

Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers

... Food and Drug Administration (FDA) has granted fast Track designation to the Company's ... we are very pleased that the FDA has granted fast Track designation to our investigational 13-valent vaccine for pediatric use." fast Track designation is designed to facilitate ...

InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA

... from the U.S. Food and Drug Administration (FDA). fast Track is a designation that the FDA reserves ... the review of the approval applications for fast track products. Dan Welch, Chairman and Chief ... of the lungs. The FDA's action in granting fast track designation is an indication of ...

Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging

... Food and Drug Administration (FDA) has granted fast Track designation to the development program ... structures by magnetic resonance imaging (MRI). fast track is a process designed to facilitate the ... fill an unmet medical need. Once a drug receives fast Track designation, frequent communication between ...

Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting

... Company Also Announces Receipt of fast Track Designation from FDA, Favorable Scientific ... events." Agennix also announced the receipt of fast Track designation from the U.S. Food and Drug ... been granted a Special Protocol Assessment and fast Track designation from the FDA, and has received ...

Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma

... Food and Drug Administration (FDA) has granted fast Track designation to Celldex's CDX-110 for the ... through additional clinical studies. About fast Track Drug Designation Under the FDA Modernization Act of 1997, designation as a fast Track product for a new drug or biological ...

R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection

... -- Pharmasset, Inc. (Nasdaq: VRUS ) has received fast track designation from the U.S. Food and Drug ... Under the FDA Modernization Act of 1997, fast track designation may facilitate the development ... need for such a condition. R7128 was granted the fast track designation primarily due to the need for ...

Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer

... today announced that it has been granted fast track designation by the U.S. Food and Drug ... Network practice guidelines. "Our receipt of fast track designation is the result of our ... severely underserved patient population." About fast Track Designation ...

ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer

... Food and Drug Administration (FDA) has granted fast track designation for ANX-510, or CoFactor(R) ... cancer chemotherapeutic agent 5-FU. "The FDA's fast track designation represents a significant step ... review and approval process for CoFactor." The fast track programs of the Food and Drug ...

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

... the global specialty biopharmaceutical company, announces it has received fast Track designation from the U.S. Food and Drug Administration (FDA) for ... to determine subsequent steps and timing for the filing of its NDA. fast Track designation is an FDA approved process that facilitates ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... of two Phase III U.S. Food and Drug Administration (FDA)-approved and fast Track designated registration trials with Urocidin is nearing complete ... of MCC when the trial endpoints are achieved. This trial received fast Track designation by the FDA last year. With Endo's support, Bioniche will ...

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

... quarter of 2008. In December 2008, Anadys announced that the FDA granted fast track designation to ANA598 for the treatment of chronic HCV. In ... will have favorable results in future clinical trials, will maintain fast track designation or will receive regulatory approval. In addition, ...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

... The U.S. Food and Drug Administration (FDA) had previously granted fast Track designation to the compound. fast Track designation allows FDA to expedite review of drugs and biologics for ...

Research Shows VASER(R) Lipo Results in Excellent Skin Tightening

... experience minimal to no pain and bruising postoperatively allowing for a fast return to normal activities. About Sound Surgical -- Founded in ... physicians and patients alike, the results are smooth and consistent with fast patient recovery. The VASER Lipo System is FDA cleared for body ....

Fast-Acting, Long-Lasting Topical Relief From Arthritis Pain

... and other chronic joint problems(1). One of the most effective ways to get fast relief from arthritis pain is the use of analgesic creams. The only ... randomized, blinded study found that Arthri-Zen Relief Cream(R) provides fast relief that is shown to last for up to eight hours. The study ...

ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients

... quarter of 2008. In December 2008, Anadys announced that the FDA granted fast track designation to ANA598 for the treatment of chronic HCV. In ... cohorts of the Phase Ib study or future clinical trials, will maintain fast track designation or will receive regulatory approval. In addition, ...

New CyberKnife Technologies Demonstrate Dramatic Reduction in Treatment Times

... now allows us to deliver radiosurgical quality treatments almost as fast as radiation therapy," said Greg Spurlock, chief operating officer of US ... Accuray Incorporated. "While other radiosurgery systems actively promote fast treatment times, plan quality often suffers accordingly. Integrating all ...

Study Shows Use of AdvanDx's PNA FISH(TM) Test was Associated with an 82% Reduction in Intensive Care Unit Mortality Rates from Staphylococcus aureus Bloodstream Infections

... bacterial infections. AdvanDx's easy-to-use products provide fast and accurate results that enable dramatic improvements in patient care and ... startup, implementation, technician and maintenance time, while providing fast results without sacrificing accuracy. Major medical centers, reference ...

Cardium's Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack

... rapid cooling but the unique integrated temperature sensor enables fast and precise feedback of core body temperature, compared to delayed ... control element and a built-in temperature feedback sensor to provide fast and precise patient temperature control. InnerCool's CoolBlue surface ...

Favrille Announces Data Cutoff for Phase 3 Registration Trial of Specifid; Data Analysis and Unblinding Expected in June

... by the U.S. Food and Drug Administration (FDA). Specifid was also granted fast Track status by the FDA in January 2006. In October 2007 an independent ... including whether it will receive expedited review as a result of the fast Track designation; Favrille's ability to manufacture sufficient quantities ...

Elite Team of Cyclists with Type 1 Diabetes Powers Forward in 2008 Sponsored by Rapid-Acting Insulin Apidra(R)

... sugar. "I began using Apidra(R) because my doctor recommended it as a fast and effective way to keep my blood sugars under control," ... for more information about Apidra(R). About Apidra(R) Apidra(R) works fast and offers flexible insulin dosing to help manage mealtime blood sugar ...

Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.

... entered Phase III clinical development in late 2006 after receiving fast Track status from the U.S. Food and Drug Administration (FDA). A second ... to begin in 2008 under the FDA's Special Protocol Assessment (SPA) and fast Track designations. The Company's Food Safety unit develops veterinary ...

Progen Announces Commencement of Global Phase 3 Study for PI-88 in Post- Resection Liver Cancer

... with world experts in this field of medicine, and with USA FDA fast Track and EU EMEA Orphan Drug Status, its initiation underscores our ... Drug designation by the European Medicines Evaluation Agency (EMEA) and fast Track designation by the United States Food and Drug Administration (FDA). ...

PARI Nebulizer & Compressor Used Exclusively in Inspire's Phase 3 CF Trial

... disease. Denufosol for the treatment of cystic fibrosis has been granted fast Track designation and orphan drug status in the United States by the FDA ... Inc. PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic ...

DiObex, Inc. Awarded Patent for the Prevention of Insulin-Induced Hypoglycemia

... to begin Phase 2 clinical testing later this year and has received fast Track status from the Food and Drug Administration, underscoring the great ... and as a convenient continuous subcutaneous infusion. DIO-901 has received fast Track status from the FDA. DIO-902 (levdexketoconazole) is an oral, single ...

Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke

... for the treatment of acute ischemic stroke. Nuvelo has also been granted fast track designation by the U.S. Food and Drug Administration (FDA) for ... facilitate expedited review of a Biologics License Application (BLA). fast track designation is reserved for new drugs that demonstrate the potential ...

Chinese SFDA Grants Immtech Fast Track Status

... of the People's Republic of China (SFDA) has granted Immtech's application fast Track Status for conducting a Phase III clinical trial with pafuramidine, ... (PCP). Pafuramidine is among the first drugs to be considered for fast Track Status under new and more stringent SFDA rules recently introduced ...

Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkin's Lymphoma (NHL)

... fast Track-Designated Study Approved Under FDA Special Protocol Assessment ... potential supplemental indication for pixantrone. Pixantrone has received fast track designation from the FDA for this indication. "We have previously ...

Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients

... Ph.D., President and CEO of AGI Dermatics. "We are optimistic that this fast Track designation will accelerate our efforts to bring to market a ... the age of 8 and their life expectancy is shortened by 30 years. fast Track programs are designed to facilitate the development and expedite the ...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

... failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Do not take ACTOS if you have active liver disease. ...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... LX1032 reduced serotonin levels and urinary 5-HIAA in healthy volunteers consistent with preclinical results. LX1032 is being developed under fast Track designation from the U.S. Food and Drug Administration and orphan drug designation from the European Medicines Agency. About ...

Results From Drug Trials and New Risk Factors Announced at International Alzheimer's Conference

... "Fortunately, the field is progressing and we may soon see changes in the landscape of Alzheimer's diagnosis, care, treatment, and prevention. How fast we get there depends completely on investment in research. We must capitalize on the advances made in the last decade." Highlights from ...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

... commercial scale. We believe our product will be highly attractive to consumers, as it has been designed to meet the market demand for a low cost, fast onset local anesthesia product." Dharma has an end-of-phase 2 meeting scheduled with the Food and Drug Administration for this fall and plans to ...

PARI LC Plus and PRONEB Ultra Used in Two Perforomist Studies on Improving COPD Therapies

... and are listed in the package insert. About PARI Respiratory Equipment, Inc. PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. PARI's worldwide vision is to improve ...

ProFibrix Initiates Phase II Clinical Trial of its Lead Topical Hemostat Product Fibrocaps(TM)

... has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting. ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in ...

Published Study Shows VNUS ClosureFAST(TM) System Significantly Superior to Laser for Varicose Vein Treatment

... that for all primary endpoints in the trial, the ClosureFAST radiofrequency catheter was statistically superior to laser treatment in providing a fast and comfortable recovery for the patient after treatment. Specifically, radiofrequency vein ablation using the ClosureFAST catheter was shown to ...