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Poniard Pharmaceuticals Reports Fourth Quarter and Year End 2008 Financial Results and Provides a Corporate Update

- Conference Call Today at 5:00 p.m. Eastern Time - SOUTH SAN FRANCISCO, Calif., March 16 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company focused on oncology, today reported financial results for the fourth quarter and year ended Decembe...

Pharmasset Reports Fiscal Year End 2008 Financial Results

PRINCETON, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported financial results for the fiscal year ended September 30, 2008. At...

Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the U.S. Food and Drug Administration (FDA) recently indicated that the ongoing ext...

Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease

Agency Supports Amigal Move to Phase 3; Eligible for Accelerated Approval; Final Global Regulatory Plan Expected by Year End CRANBURY, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD ), a biopharmaceutical company developing small molecule, orally-administere...

Tolerx Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting

Phase III study will evaluate effects of otelixizumab, an investigational anti-CD3 monoclonal antibody, on preservation of endogenous insulin secretion CAMBRIDGE, Mass., April 9, 2008 /PRNewswire/ - Tolerx, Inc., a biopharmaceutical company engaged in the discover...

Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights

BERKELEY HEIGHTS, N.J., March 12 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA ) today announced financial results and progress for the quarter and year ended December 31, 2007. The Company noted significant recent milestones, including: -- AGENDA Phase 3 trial using key b...

New Studies End Debate on Embryonic Stem Cell Research

WASHINGTON, Nov. 20 /PRNewswire-USNewswire/ -- Today, Family Research Council President Tony Perkins praised the research of Dr. James Thomson and Dr. Shinya Yamanaka. Thomson, the first to grow human embryonic stem cells, and Yamanaka from Japan, published results in the journals Science and ...

Velos Set to Clear 50 Percent Market Penetration of Large U.S. Clinical Research Sites by Year End

FREMONT, Calif., Aug. 7 /PRNewswire/ -- Velos, Inc., the recognized leader and trusted resource for clinical trial management information systems for large investigator sites, today announced it will cross the 50 percent market penetration threshold by year end. The company's flagship product,...

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

... million for the same period in 2008. Maintaining its strong cash position, Isis ended the quarter with $637.5 million of cash and remains on track to end 2009 with more than $550 million of cash. Isis also remains on track to meet its guidance of more than $145 million of pro forma net income and a pro ...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...ression (HAMD-17) total score from baseline to the end of the study in the trazodone group versus the pla... of 0.012). The majority of the secondary efficacy end points, including the HAMD-17 depressed mood item,...ments versus placebo in all three quality of sleep end points, with an improvement by the first week of t...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

...ty and efficacy findings; (ii) the timing or success of the commencement or end of clinical trials and commercial launch of partnered products may be delay... ------- ------ Cash and cash equivalents at end of period $114,992 $31,829 ...

Medigus and Tower Semiconductor Announce World's Smallest Medical Video Camera Based on Advanced CMOS Image Sensor

...be incorporated into disposable endoscopes or used in various diagnostic and surgical medical applications. First product samples have been shipped to end customers and mass production of the camera is expected to commence in mid-2010. The camera sensor will be manufactured in Tower's Fab2 using its 0.18...

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

...y become available and enables the agency to commence its review on a rolling basis. The company expects to complete the NDA submission by the end of this quarter. Background on Gaucher disease Gaucher disease is an autosomal recessive disease and the most prevalent Lysosomal ...

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

...g Millennium Villages in Ghana and Tanzania. The non-profit's mission is to end poverty around the world through sustainable development at the individual,...rformance targets and disburses money in response to proven results. At the end of 2008, programs supported by the Global Fund have averted more than 3.5 m...

British Woman Celebrates a Year of Living Cancer-Free

...ctory disease enjoy long-term remission," Dr. Kottaridis said. "However, this is a Phase I study that has been designed to assess toxicity as the main end point, efficacy being a secondary one. It is very important for us to be able to recruit more patients and complete the current phase before moving to...

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

...postmenopausal women with an intact uterus aged 40 to 75 years. The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. Secondary end points included bone mineral density (BMD) at two years, menopausal vasomot...

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

...or at least a 70% (ACR 70) improvement, from the baseline assessment at the end of the 3 month treatment period. The ACR measurement factors included repor...ents assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 3 months. Secondary efficacy endpoints included other ACR scores and, a...

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

... IMC-11F8 is expected to move into Phase III development by the end of 2009; Phase II testing of IMC-A12 has been expanded to include col... to file at least one new investigational new drug (IND) application by the end of 2009. According to Lilly Chairman, President and CEO John ...

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

... observed in this study per cohort: end of Treatment Mean Patients with 1 log10 or Cha...r Reduction in HCV Cohort Dose (log10) RNA at end of Treatment ------ ---- --------------------- -------------...

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

...hs, of 1.5 percentage points from baseline, compared to a reduction of 1.3 percentage points for Lantus after completing 26 weeks of treatment. At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8 percent compared with a mean A1C of 7.0 percent in those treated ...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

...tion of TNF-alpha and other pro-inflammatory cytokines. Results of the dose escalation and safety study in healthy volunteers are expected before the end of the year. "Based on extensive work with the predecessor compound, we believe CPSI-2364 has the potential to revolutionize the treatment of...

AlphaVax Announces Results from Initial Testing of Its H1N1 (Swine) Influenza Vaccine

...d process development and preclinical immunogenicity studies of its H1N1 (swine) influenza vaccine and will manufacture clinical trial material by the end of the month. This vaccine has shown good production yields as well as excellent immunogenicity, even after just a single inoculation. "Our ...

Velos, Inc. Releases Software to Support Cancer Centers With New Workflow and Content for NCI Clinical Trials Reporting Program

...n the process of posting new interventional studies to the NCI database. Changes to existing trials will also be posted and it is expected that by the end of 2009, the process will be well underway with all NCI grantees posting proscribed information on all interventional trials. Registration of observat...

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

...or at least a 70% (ACR 70) improvement, from the baseline assessment at the end of the 6 month treatment period. The ACR measurement factors include report...ents assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 6 months. Secondary efficacy endpoints included a comparison of respons...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... it is an endeavor worthy of strong support. It is hopeful that MARVEL II, which is one stage of the broader MARVEL program, will meet a key efficacy end point - the six-minute walk." Dr. Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine, discussed the difficulties of ...

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

... final event driven analysis, also published in The Lancet . Further to the final analysis, additional follow-up results will be forthcoming from the end of study About Cervarix (R) Cervarix (R) was specifically designed with a novel adjuvant, AS04, to deliver high and sustaine...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

...rly Treatment Diabetic Retinopathy Study (ETDRS) scale; the scores at study end were similar in both treatment groups (Lantus(R): 14.2%, NPH: 15.7%; 95% CI...erences in blood glucose control. Both groups had comparable HbA1c at study end (mean HbA1c improved from a baseline of 8.4% and 8.3% to 7.8% and 7.6% for ...

Calixa Therapeutics Announces Initiation of Phase 2 Clinical Trial of Its Antibiotic, CXA-101, in Patients with Complicated Urinary Tract Infections

...dard of therapy. The primary efficacy endpoint for this study is microbiological outcome at the test-of-cure visit between six to nine days after the end of therapy. "The preclinical and Phase 1 results to date are very promising and indicate that CXA-101 is well tolerated and has broad-spectrum an...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

...rol appropriate even for patients who are restricted from oral medication. Patients appear to tolerate the Sufentanil NanoTabs well, and following the end of the 12-hour study period when they were switched to IV PCA morphine, many requested that they be returned to study drug. To me, these patients' req...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

... with the regulatory authorities as a monotherapy treatment for COPD at the end of 2008. The combination of NVA237 and indacaterol is known as QVA149. NDA ... the anticipated commencement of the Phase III study for QVA149 towards the end of this year." Dr Chris Blackwell, Chief Executive of Vectura, added...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

...one HCl, and the Side Effects and Symptoms Questionnaire (SESQ) and the Niacin Tolerability Rating Scale (TRS) were used to assess niacin tolerability end points. Results showed that approximately 75 percent of all volunteers in all groups rated the tolerability of study drugs as easy to tolerate or as h...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

...and safety will also be assessed at various intervals over six months in both studies. It is estimated that these two studies will be completed by the end of 2010. Dr. Steve Pakola, Chief Medical Officer of ThromboGenics, commenting on the announcement said, "We are very pleased that the Phase III...

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

...endpoints. Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium 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 right...

ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases

...lism. Orphan disease indication targets for inflammatory diseases may be pursed through clinical trials focused on arachidonic acid specific surrogate end points. David K. Barker, Founder and CEO of ALP Life Sciences, LLC stated, "The preliminary evidence for the Nanoveson(TM) hypotheses is very pro...

Spherix Announces Positive Phase 2 Study Results

... triglycerides of the patients by -59 mg/dl by the end of the first month on therapy, a decrease from baseline that remained at -41 mg/dl by the end of the 6 months of the trial. Naturlose also decreased serum LDL by an average -13 mg/dl by the end of the first month on therapy, while serum HDL was...

New Therapy Found to Prevent Heart Failure

... and Boston Scientific, the study's sponsor. The MADIT-CRT Executive Committee stopped the trial on June 22, 2009, when the trial achieved its primary end point - significant reduction in heart failure or death with CRT-D versus ICD-only. Cardiologist Arthur Moss, M.D., professor of Medicine at the Un...

ADHD Genes Found; Known to Play Roles in Neurodevelopment

... "Instead, there may be hundreds of genes involved, only some of which are changed in each person. But if those genes act on similar pathways, you may end up with a similar result -- ADHD. This may also help to explain why children with ADHD often present clinically with slightly different symptoms." ...

HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens

...d if immediate steps are taken to help people take their prescription drugs properly. Commonly referred to as pharmaceutical noncompliance, the end result of Americans not taking their prescription drugs properly is a well-documented phenomenon that drains more than $180 billion from our national ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

...e of the U.S. while Amicus retains all rights to commercialize these products in the U.S. In addition, Amicus leads development operations through the end of Phase 2 clinical trials. The companies then share responsibility for Phase 3 clinical trial development leveraging Shire's significant ex-U.S. regu...

Scottsdale Facility to Be First in U.S. to Showcase True REST Technology

...ona study examined chamber REST as a relapse prevention technique for substance abusers enrolled in traditional outpatient treatment programs. At the end of four years of follow-up, 43 percent remained continuously sober and drug-free. None of the control group did so for eight months of follow-up. ...
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