receive in Medical Technology

Acura and King Receive FDA Complete Response Letter Regarding Acurox(R)

PALATINE, Ill. and BRISTOL, Tenn., July 2 /PRNewswire-FirstCall/ -- Acura Pharmaceuticals, Inc. (Nasdaq: ACUR ) and King Pharmaceuticals, Inc. (NYSE: KG ) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (...

ThromboGenics and BioInvent Receive Technology Transfer Success Fee From Roche for the Novel Anti-Cancer Antibody, TB-403 (Anti-PIGF)

LEUVEN, Belgium and LUND, Sweden, January 26 /PRNewswire-FirstCall/ -- ThromboGenics NV (EURONEXT:THR) and BioInvent International AB (OMXS:BINV) announce today that they have received a technology transfer success fee of EUR5 million from Roche under the terms of their strategic alliance for ...

Long-Term Phase I and Phase I/II Trial Data Continue to Show Striking Improvement in Survival of Brain Cancer Patients Who Receive DCVax(R)-Brain

BETHESDA, Md., Sept. 11 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBT and NWBS) ("NWBT" or the "Company") today announced the most recent long-term follow-up data, through June 15, 2008, from its prior Phase I and Phase I/II clinical trials with...

First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery at University of Michigan

National trial aims to help heart failure patients survive until transplant, and may offer lower clot risk and less blood damage than earlier heart devices ANN ARBOR, Mich., Aug. 5 /PRNewswire-USNewswire/ -- Anthony Shannon made history on July 30. That's when he became the first person in t...

Silence Therapeutics to Receive $1.9m Milestone Payment as Pfizer and Quark Commence Phase II Trial

LONDON, July 30 /PRNewswire/ -- Silence Therapeutics plc (AIM: SLN), a leading European RNAi focused biotechnology company, today announces that its partner, Quark Pharmaceuticals Inc. ("Quark") together with Pfizer, has commenced a Phase II clinical trial with RTP-801i-14 (PF-4523655), a smal...

Medarex to Receive Milestone Payment from Amgen

PRINCETON, N.J., Dec. 18 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX ) today announced that it will receive a milestone payment for an undisclosed amount from its licensing partner, Amgen, for advancing an antibody into human clinical trials. The antibody was developed using Medarex...

Five Clinical Studies to Receive $2.5 Million Under Foundation's 2007 Clinical Discovery Program

NEW YORK, Dec. 4 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research today announced approximately $2.5 million in total funding for five clinical research studies under its 2007 Clinical Discovery Program. In keeping with the Foundation's focus on accelerating sc...

Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance

First step for performing important diagnostics in physician offices MADISON, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX ), the nation's leading provider of diagnostic testing, information and services, today announced that its HemoCue and Focus Diagnos...

BioMosaics' Glypican-3 Blood & Tissue Tests Receive CE Marking in Europe

BURLINGTON, Vt., Sept. 10 /PRNewswire/ -- BioMosaics Inc., a cancer biomarker development company, announced today that it has received CE marking for its proprietary products for the identification of Glypican-3 (GPC3) in human blood and in tissue as in vitro diagnostic tests. This will allow...

Sixty-One Percent of Newly Diagnosed Parkinson's Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis

Levodopa Remains the Most Widely Prescribed Drug for Parkinson's Disease, According to a New Report from Decision Resources WALTHAM, Mass., Aug. 13 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issu...

International Movement Disorder Specialists Receive New Information About the Use of Once-Daily Azilect in the Treatment of Parkinson's Disease

Results presented at the Movement Disorder Society's 11th International Congress in Istanbul, Turkey KANSAS CITY, Mo., June 08, 2007 /PRNewswire-FirstCall/ -- New information on the use of AZILECT(R) (rasagiline tablets) for the treatment of Parkinson's disease (PD) was reported this week at The M...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

...nation with chemotherapy for M etastatic colorectal cancer to determine E fficacy) enrolled 1,183 patients globally. Patients were randomized to receive either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study is progression-free surviv...

NewCardio Announces Master Services Agreement With Dedicated Phase I

...(MSA) with NewCardio. Under terms of this agreement, Dedicated Phase I will receive a license to use NewCardio's QTinno(TM) software solution in all TQT studie...mers on the overall cost of the study. The net result is that sponsors will receive higher quality study results and also save time and money. This is a win-wi...

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

...cer (excluding breast and prostate cancer) or multiple myeloma. Patients enrolled in this event-driven study were randomized in a one-to-one ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg single, 15 minute infusion eve...

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

... clinical manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or a readily palpable enlarged liver. Patients were randomized to receive velaglucerase alfa at either 45 U/ kg or 60 U/ kg for a duration of 12 months. In the trial, the primary endpoint was reached with patients ben...

John Legend and Gap Join (PRODUCT)RED(TM) to Help Eliminate AIDS in Africa with Exclusive (RED)ZONE Seating at Madison Square Garden

...one ticket in the reserved RED(ZONE) section for John Legend's MSG show. Even better, with each (RED)ZONE ticket purchase, shoppers will automatically receive a second ticket to the show free of charge. Additionally, a select number of fans seated in the (RED)ZONE section will be randomly selected to go back...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...daily (QD) dosing for 3 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized to receive either PSI-7851 (8 patients per cohort) or placebo (2 patients per cohort). Three dose cohorts of PSI-7851 (50mg QD, 100mg QD, 200mg QD) were evaluate...

British Woman Celebrates a Year of Living Cancer-Free

... Joanne Scott went through a cancer treatment that changed her life -- and made history to boot. Ms. Scott, 54, was the first person in the world to receive an injection of tumor-activated natural killer (TaNK) cells as a treatment for leukemia. Her doctors at the Royal Free Hospital in London recom...

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

...bility frequently leads to treatment discontinuation even when the treatment is providing some benefit. To help manage this challenge, patients often receive multiple medications or need to switch treatments. About Schering-Plough Schering-Plough is an innovation-driven, science-centered globa...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

...lity of data and other information that may affect regulatory review and commercialization of BZA/CE. There can be no assurance that BZA/CE will ever receive regulatory approval or be successfully developed and commercialized. Other risks and uncertainties include, among others, risks related to our prop...

World's First Cardiac Adult Stem Cell Patient Receives Infusion

...ed. Since this is a phase-one clinical trial designed to test the treatment's safety and feasibility, all patients enrolled in the trial will receive the cardiac stem cell therapy. Individuals wishing to learn more about this study should call 502-852-1387 or email cardiactrial@louisville....

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... of up to 3 months. Patients were assigned on a 2:1 basis to R788 or placebo. Throughout the clinical trial period, all of the patients continued to receive their stable dose of methotrexate. Efficacy assessments for each participant were based on the American College of Rheumatology criteria, whi...

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

...pment, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the products will receive regulatory approval, or that the regulatory approval will be for the indications anticipated by the company. There is also no guarantee that the produ...

Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results

...system was used for one graft and the conventional hand-sewn technique for the other, for a total of 440 randomized grafts. Patients were scheduled to receive a follow-up angiogram nine months after their index procedure to determine patency (or degree of openness of the vein graft) for both the PAS-Port and...

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

... hypertension in an 8-week, randomized, double-blind, placebo-controlled, parallel-group, 15-arm factorial trial (n=2762). Patients were randomized to receive various combinations of Tekturna (75 mg to 300 mg) plus hydrochlorothiazide (6.25 mg to 25 mg) once daily (without titrating up from monotherapy) and ...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

... histologically documented metastatic breast cancer with measurable disease that is ER-negative, PR-negative, and HER2- non-overexpressing. They will receive the chemotherapy combination of gemcitabine/carboplatin with or without BSI-201. Patients must have measurable metastatic breast cancer with ...

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

...ion study evaluated the safety and antiviral activity of IDX184. In this study, 41 treatment-naive HCV genotype-1-infected patients were randomized to receive either IDX184 or placebo once-daily for three days. Four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg) of IDX184 were evaluated. IDX184 was well tol...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

...betes who were not achieving adequate glucose control using metformin therapy alone or in combination with a sulfonylurea. Subjects were randomized to receive exenatide once weekly 2 milligrams by subcutaneous injection weekly or insulin glargine injections administered daily in a variable dose determined by...

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

... or placebo (BLISS-52, n=287). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies. ...

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

...est effort to file its New Drug Application and to receive a manufacturing approval as soon as possible in Ja...n. Under the terms of the agreement, BioCryst may receive future clinical and commercial event milestone pay...s contained herein include: that peramivir may not receive emergency use authorization; that the U.S. governm...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

...th AF with a CHADS2 index greater than or equal to 2 were enrolled in the initial Phase II study for three months. Patients were randomly assigned to receive either one of the four fixed dose regimens of edoxaban (30mg/N=235 or 60mg/N=234 administered once daily; 30mg/N=244 or 60mg/N=180 administered twice ...

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

...rent/progressive pediatric tumors. A standard 3+3 dose escalation design will be employed with 3 to 6 patients at each dose level. All patients will receive perifosine at a loading dose on the first day, followed by a maintenance dose to start on day two until progression of disease. A minimum of 4 and a ...

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

...l payments linked to the achievement of future clinical, regulatory, and commercial milestones. In addition, Bioniche will manufacture the product and receive a transfer price for supply. "We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stag...

First Patient of NOTES Investigational Device Exemption (IDE) Study Successfully Treated With Ethicon Endo-Surgery Devices

...nd NOTES specific technology, which holds great promise for improving surgery for both patients and physicians." The study, which is the first to receive an investigational device exemption (IDE) to study devices for NOTES, will include up to 40 subjects undergoing either a diagnostic peritoneoscopy or ...

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

... subjects were treated at two clinical sites. The trial included subjects representing a wide range of ages and ethnicity. Subjects were randomized to receive an 8 minute administration of lidocaine plus epinephrine (Active arm) or epinephrine alone (Placebo arm) at the site of insertion of an intravenous ca...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... placebo for a period of 6 months. Within in each cohort, patients were assigned on a 2:1 basis to R788 or placebo. All of the patients continued to receive their same stable dose of methotrexate throughout the clinical trial period. Efficacy assessments for each participant were based on the Americ...

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

... in the treatment of bone metastases in patients with advanced breast cancer. Patients enrolled in the study were randomized in a one-to-one ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg single, 15 minute infusion eve...

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

... is to show proof of principle that a new molecule is a viable candidate for expanded clinical evaluation. As a RAID award recipient, Dr. Epstein will receive access to drug development resources of the Developmental Therapeutics Program. These resources will be used to further the preclinical development of...

Landmark Study for GSK's Cervical Cancer Vaccine Published in The Lancet

... aged between 15 and 25 years, from 14 countries across Europe, Asia-Pacific and Latin and North America Study participants were randomised to receive either Cervarix (R) or a control hepatitis A vaccine and analyses were performed in the following cohorts: According-to-protocol cohort f...

Number of Patients With Dementia on the Rise

...ve a keen interest in patients like Sabin. The center first received grant support from the National Institutes of Health in 1989 and has continued to receive funding since. Researchers at the MADRC have so far studied 80 patients in a project that has been going on for four years on the diagnosis of Al...