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Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

LEXINGTON, Massachusetts, July 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement t...

Siemens Corporate Research Develops RAPID2 System for Fast Discovery of Discriminative Pathogen Signatures

RAPID2 identifies relevant signatures for H1N1 virus in record time PRINCETON, N.J., May 21 /PRNewswire-FirstCall/ -- Siemens Corporate Research (SCR), Inc. ( www.usa.siemens.com/research ) announced that it developed the RAPID2 system to speed the biomarker discovery process for the devel...

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

HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer). ...

Clinician Reports Fast Healing of Intractable Wounds Using MEDIHONEY(R)

Jason Hanft of Baptist Health South Florida Reports on 11 Patients at SAWC PRINCETON, N.J., April 29 /PRNewswire-FirstCall/ -- Derma Sciences (OTC Bulletin Board: DSCI), a provider of advanced wound care products, announced that yesterday at the annual Symposium on the Advances in W...

Image Guided Radiation Therapy in Latham, NY. Now Fighting Cancer Using Fast and Precise RapidArc(TM) Radiotherapy Technology

Patient calls it a 'miracle' LATHAM, N.Y., Aug. 25 /PRNewswire-FirstCall/ -- Clinicians from the Image Guided Radiation Therapy program at Community Care Physicians in Latham have commenced treating cancer patients using RapidArc(TM) radiotherapy technology from Varian Me...

Studies of an Innovative Catheter Ablation System for Atrial Fibrillation Reveal Excellent Outcomes, Safety Profile and Fast Procedure Times

Presentations at Cardiostim World Congress Focus Attention on a New Ablation Technology CARLSBAD, Calif., June 24 /PRNewswire/ -- Ablation Frontiers, Inc. today announced that two studies reporting positive findings about its novel atrial fibrillation catheter ablati...

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

COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infant...

InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA

- Conference call scheduled to discuss Shionogi Phase 3 results on pirfenidone - BRISBANE, Calif., May 19 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN ) today announced that its program for the development of pirfenidone for the treatment of idiopathi...

Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging

WALTHAM, Mass., April 16 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN ) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for RG1068, synthetic human secretin, to improve the assessment of pancreatic ...

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

SAN CARLOS, Calif., Dec. 12 /PRNewswire-FirstCall/ -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced dosing of the first patient in a Phase 2 proof-of-concept trial of alfimeprase for the treatment of acute ischemic stroke. Nuvelo has also been granted fast track designation by the U.S. Food ...

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

PRINCETON, N.J., Oct. 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ) has received fast track designation from the U.S. Food and Drug Administration (FDA) for R7128 for the treatment of chronic hepatitis C virus (HCV) infection. R7128 is a prodrug of PSI-6130, an oral cytidine n...

Chinese SFDA Grants Immtech Fast Track Status

NEW YORK, Sept. 27 /PRNewswire-FirstCall/ -- Immtech Pharmaceuticals, Inc. (Immtech) (Amex: IMM ) announced today that the State Food and Drug Administration of the People's Republic of China (SFDA) has granted Immtech's application Fast Track Status for conducting a Phase III clinical trial ...

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

- Phase 2 Median Overall Survival Confirmed and Extended at the 12th World Conference on Lung Cancer in Seoul - SOUTH SAN FRANCISCO, Calif., Sept. 5 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company focused on oncology, today ...

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

FREEPORT, N.Y., Sept. 5 /PRNewswire/ -- AGI Dermatics, the bio- pharmaceutical laboratory that pioneered DNA research for skincare, announced today that U.S. Food & Drug Administration (FDA) has granted Fast Track designation for Dimericine (T4N5) for treatment of solar and ultraviolet photose...

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

SAN DIEGO, Aug. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX ) a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced that the U.S. Food and D...

Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 16, 2007 - Gloucester Pharmaceuticals, Inc., an oncology focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel histone deacetylase inhibitor, romidepsin, for the mon...

Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients

Proposed Phase III Trial Has the Potential to Demonstrate an Effect on a Serious or Life Threatening Aspect of This Disease SEATTLE, May 07, 2007 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) announced today it received fast track designation from the U.S. Food and Drug Administration (F...

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

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

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

...rt 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. You...

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

...tudies, 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 Carcinoid...

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

...on. "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 ICAD...

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

...first of two Phase III U.S. Food and Drug Administration (FDA)-approved and fast Track designated registration trials with Urocidin is nearing complete en...istration 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 ...

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

...at 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

...lution 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 the...

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

...ibrocaps 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 the...

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

...ound 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 r...

ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease

...d, low-dose formulation of bromfenac has the potential ability to effectively and conveniently treat signs and symptoms of dry eye disease and provide fast and sustainable relief for patients. Bromfenac's strong safety profile should support long-term treatment, which would be necessitated due to the chr...

TNFerade(TM) Phase III Data Presented at ASCO

...fects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF alpha in the tumor. TNFerade has been granted fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. ...

Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009

...ansduction inhibition and cell-cycle kinase inhibition. BIBW 2992 entered Phase IIb/III clinical development in NSCLC earlier in 2008 and was granted fast Track designation for a third/fourth line treatment indication in NSCLC by the US Food & Drug Administration. In addition, the LUME-Lung Phase III...

RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days

...ective relaxation of the targeted prostatic muscle tissue, with a low incidence of vasodilatory and orthostatic effects. RAPAFLO(TM) (silodosin) is a fast acting, effective and safe treatment for the signs and symptoms associated with BPH." BPH is the number one reason patients visit urologists and...

Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial

...ted at the North American Cystic Fibrosis conference in Minneapolis in October. Bronchitol has received Orphan Drug Designation and development fast track status from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency. Bronchitol is designed ...

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis

...eakthrough disease while on established interferon-beta therapy. This trial was announced in January 2007. Cladribine Tablets have been granted a fast track designation by the US Food and Drug Administration based on the need for an oral therapy in a subset of patients with relapsing forms of multipl...

Lexicon Pharmaceuticals Provides Clinical Pipeline Update and Reports 2009 First Quarter Results

...1 at the Digestive Disease Week (DDW) annual meeting on May 31, 2009. Lexicon is advancing its LX1032 drug candidate, which has received fast Track status from the U.S. Food and Drug Administration (FDA), into a Phase 2a study in patients with carcinoid syndrome . Lexicon has identified ...

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

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

Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin

...ho collaborated closely with Cepheid and FIND with support from the NIAID. "We're gratified to find that it requires less hands-on work than the acid fast smear, long a standard method to identify tuberculosis, but it is much more sensitive." Sputum microscopy, which often delivers poor sensitivity ...

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

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

SAFC Biosciences(R) and Vivalis Collaborate to Optimize Cell Culture Media for Vaccines Production

...hicken embryo fibroblasts, while eliminating the risk of contamination and the costs associated with serum for growing the fibroblasts. EB66 cells are fast becoming the recommended industry alternative for the safe, cost effective manufacturing of viral vaccines and recombinant proteins for human and vete...

Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis

...component of the trial will examine the safety of Bronchitol in people with cystic fibrosis. Pharmaxis has received Orphan Drug Designation and fast track status from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for Bronchitol in cystic fibros...

Poniard Completes Patient Enrollment Target in Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer

...ent arm. The trial is also being conducted under a Special Protocol Assessment (SPA) developed with the FDA. Poniard has received Orphan Drug and fast Track designations for picoplatin for the second-line treatment of refractory or resistant SCLC from the FDA, and Orphan Drug designation from the Eur...

Astrocytes Help Separate Man From Mouse

... in mice and rats. In addition to the findings above, the team noted additional differences: Astrocytes in people signal five times as fast as those in mice and rats. Human astrocytes are organized into more complex units known as domains than are rodent astrocytes. A typical roden...
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