drug in Medical Technology

Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

... ANGELES, Aug. 7 /PRNewswire-USNewswire/ -- A new drug delivery system that uses a tiny silicone cup filled with any drug and sealed to the outer surface (episclera) of ... Summer Eye Research Conference on Ophthalmic drug Delivery Systems in Bethesda, MD, Dr. Murphree ...

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

... Begin clinical trials on at least one additional drug in 2009; clinical trials already initiated on ... drugs into development in 2009; one new drug has already moved into development this year ... earned $1.4 million of revenue when Isis sold drug to OncoGenex Pharmaceuticals, Inc. ...

Juvenile Diabetes Research Foundation, The Genomics Institute of the Novartis Research Foundation Announce Innovative Diabetes Drug Discovery and Development Partnership

... Research Foundation (GNF) to create a diabetes drug discovery and development platform. The ... JDRF and GNF aims to deliver a succession of drug candidates to the clinic over the next four ... in the discovery of beta cell regeneration drug targets and candidates, and allows for the ...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

... seen with Forteo(R) (teriparatide), the reference drug used in this dose-finding study. The ... agent approved for marketing by the U.S. Food and drug Administration for the treatment of osteoporosis ... discovery and development of a new generation of drug therapies for osteoporosis and women's health. ...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

... achievements underscore the strength of Nektar's drug development organization and our successful ... technology platforms. Nektar's technology and drug development expertise have enabled nine approved ... of the company's pipeline of proprietary drug candidates, the value and potential of the ...

Debiopharm Group and Mercury Therapeutics, Inc. Sign an Exclusive License Agreement for the Development and Commercialisation of Debio 0930

... promising biological and small molecule drug candidates. It develops its products for global ... pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs. ... disease. Mercury is focusing its internal AMPK drug development program for indications in oncology. ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... denosumab oncology clinical trials testing the drug for bone loss and destruction associated with ... candidates are not approved by the U.S. Food and drug Administration (FDA), and no conclusions can or ... of the labeling approved by the U.S. Food and drug Administration (FDA) for the products. The ...

Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome

... Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and ... The company's most advanced investigational drug candidates in clinical development are TELINTRA, ... candidates were discovered using its proprietary drug discovery technology, TRAP((R)), which enables ...

Project Zero Delay Accelerates Drug's Path to Clinical Trial

... 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 ... about 12 years and the cost of bringing a new drug to patients has been estimated at around $1.3 ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... Aug. 3 /PRNewswire/ -- The U.S. Food and drug Administration approved INVEGA(R) SUSTENNA(TM) ... SUSTENNA(TM) was developed utilizing Elan drug Technologies' proprietary NanoCrystal((R)) ... United States, and Asia. J&JPRD is leveraging drug discovery ...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

... for ProLindac , a novel DACH platinum drug that has shown to be active in many solid ... drugs in that patient population, and that the drug was very well tolerated. ProLindac is a novel DACH platinum drug that has shown to be active in many solid tumors ...

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

... SGP ) today announced that the U.S. Food and drug Administration (FDA) Psychopharmacologic Drugs ... by FDA, SAPHRIS would be the first psychotropic drug to be approved initially for both of these ... indications, respectively. The New drug Application (NDA) for SAPHRIS includes efficacy ...

Popular Breast Cancer Drug Used with Certain Antidepressants Puts New Jersey Women at Risk

... women in New Jersey who take the breast cancer drug tamoxifen in conjunction with certain popular ... called endoxifen, from being produced, making the drug less effective at preventing breast cancer. Women ... among women with estrogen-dependent tumors. The drug works by blocking the estrogen receptors in the ...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

... affecting serotonin function for antidepressant drug development," said lead investigator Maurizio ... was able to identify the pathway, ratio of drug and dosing that shaped the clinical trial protocol, directing the first rational approach to drug development in the area of psychiatry." ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... topical anesthetic. As part of the ongoing new drug application (NDA) review, the U.S. Food and drug Administration (FDA) requested the study to ... The NDA for Qutenza in PHN has a Prescription drug User Fee Act (PDUFA) date of August 16, 2009. ...

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

... received notification from the U.S. Food and drug Administration (FDA) that the FDA extended the review of the New drug Application (NDA) for the fixed-dose combination ... (pioglitazone HCl). The new Prescription drug User Fee Act (PDUFA) date for the FDC is ...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

... worked collaboratively with the U.S. Food and drug Administration (FDA) to design this study, which ... goal of initiating the filing in 2009 of a New drug Application for picoplatin as a second-line ... business objectives and strategic goals, drug development plans, and the potential safety and ...

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

... announced today that it has received orphan drug designation from the Committee for Orphan Medical ... Agency (EMEA) for LX1032 , the company's oral drug candidate for managing gastrointestinal symptoms ... and veterinary use. The goal of EMEA's orphan drug program is to promote the development of drugs ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... being developed by our company as a therapeutic drug of androgenetic alopecia (male pattern baldness; ... to that of the remaining 3 subjects. The applied drug was spread widely covering the vertex region in ... were collected in the lapse of time to determine drug concentrations. However, ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

... N.J., July 21 /PRNewswire/ -- The US Food and drug Administration (FDA) has approved Tekturna ... greater blood pressure reductions than either drug alone. "Up to 85% of patients will need ... pressure reductions, compared to taking either drug alone." Hypertension affects nearly 74 ...

National Cancer Institute Research Identifies Unique Mechanism of Brostallicin's Anti-Tumor Effectiveness

... our focus on personalized approaches to cancer drug development," said Jack Singer, M.D., Chief ... merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and ... to be particularly sensitive (vulnerable) to a drug or combination of drugs--the "context of ...

Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)

... viral load data suggest no evidence of drug accumulation. The table below summarizes mean HCV ... for IDX184 and plans to file investigational new drug applications in the coming months from our ... nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with ...

Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results

... First Phase 3 Lupus drug Trial in Decades to Show Effectiveness ... Dowd. "We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 ... System in New York. "There is no doubt that a drug approval will foster ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... the potential to become the first new approved drug in decades for people living with systemic ... 2010." Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory ...

Bionovo's Estrogen Receptor Beta Selective Drugs Have Unique Gene Expression and Cell Type Specificity

... symptoms. "It is essential that new drug candidates demonstrate drug selectivity and tissue specificity in order to minimize adverse effects, particularly when the drug is being developed for the treatment of common, ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... review of peramivir by the U.S. Food & drug Administration." "This data represents ... Phase 3 studies successfully conducted with a drug candidate discovered by BioCryst," said Jon P. ... Company is making its best effort to file its New drug Application and to receive a manufacturing ...

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

... Cognition Therapeutics Inc., a Pittsburgh-based drug discovery company developing small molecule ... J.D. "Our combination of novel, small molecule drug candidates and biologically-relevant screening ... healthcare systems as the population ages. The drug candidates being developed by Cognition have the ...

Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks

... fibrosis patients has received a second orphan drug designation in the US only weeks after a first ... of Orphan Products Development of the US Food and drug Administration (FDA) has granted a second orphan drug designation to its lead product ...

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

... Highlights from ICAD 2009 include: DHA drug Trials Results from two large studies ... of Alzheimer's. Phase III Alzheimer's drug Raises Level of a Toxic Protein Recent evidence suggests that the drug Dimebon may improve cognitive function in people ...

Michael J. Fox Foundation Awards Over $2 Million for Validation of 10 Parkinson's Therapeutic Targets

... and historically underresourced phase of drug development in which researchers work to ... a molecule or mechanism of interest is a true drug target. While researchers have continued to ... and financial resources to help push potential PD drug targets one step closer to clinical trials and ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... denosumab oncology clinical trials testing the drug for bone loss and destruction associated with ... candidates are not approved by the U.S. Food and drug Administration (FDA), and no conclusions can or ... of the labeling approved by the U.S. Food and drug Administration (FDA) for the products. The ...

Thiarabine Demonstrates a Reduction of Both Inflammatory and Erosive Disease Parameters in Rheumatoid Arthritis

... to methotrexate, a commonly used clinical drug for RA treatment, high resolution 3-D images from ... shortly after FDA clearance of the protocol and drug recertification." Access is actively ... mucositis. The company also has other advanced drug delivery technologies including ...

USC Keck School of Medicine's Dr. Alan Epstein Receives Prestigious National Cancer Institute RAID Award for Breakthrough IL-2 Molecule Therapeutic

... Medicine has received approval for a $3.5 million drug development project through the Rapid Access to ... recipient, Dr. Epstein will receive access to drug development resources of the Developmental ... - with novel applications in new therapies, drug delivery, and patient care," said Dr. Richard ...

New Small and Medium Sized Enterprises Join TI Pharma by Signing Two New Projects

... for the treatment of cancer. Versatile drug delivery platform for inflammatory diseases and cancer New molecular entities (NMEs) in the drug development pipeline comprise various classes of ... chemical modification of NMEs is combined with drug formulation studies. This will lead to a ...

BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

... -- BioCis Pharma Ltd., a privately held drug development company with its headquarters in ... cream, the company's novel topical drug for dermatology. This double-blind, ... as a hallmark feature of atopic dermatitis. Any drug showing capacity for restoring this disturbance ...

Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Patient Value

... this Phase III study, Eisai plans to submit a New drug Application (NDA) with the U.S. Food and drug Administration (FDA) in August or September 2009. ... medication approved by the U.S. Food and drug Administration for mild, moderate and severe ...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

... that it has submitted a supplemental New drug Application (sNDA) to the U.S. Food and drug Administration (FDA) requesting approval of ... with long flights. "This supplemental New drug Application for a new use of NUVIGIL is another ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been ... (golimumab) was approved by the U.S. Food and drug Administration (FDA) and Health Canada for the ... SIMPONI treatment. The most common adverse drug reaction reported from clinical trials through ...

MJFF's Rapid Response Innovation Awards Hit Mid-2009 With Over $1 Million Funded in High-Risk/High-Reward Approaches to Parkinson's Disease

... of the safety and efficacy of an FDA-approved drug for kidney disease to treat Parkinson's; ... Colorado has discovered that phenylbutyrate, a drug already approved by the U.S. FDA to treat kidney ... in pre-clinical models of Parkinson's. The drug may turn on a protective gene called DJ-1 in the ...

Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)

... of the antibiotic amikacin, which encloses the drug in nanocapsules of lipid called liposomes. This ... study. ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines ...