Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients : Lancet Neurology Publishes Pivotal Phase III Data Supporting Zonegran® (Zonisamide) as a Once-Daily Monotherapy for Newly Diagnosed Partial Onset Epilepsy Patients PR Newswire HATFIELD, England, June 27, 2012 HATFIELD, England, June 27, 2012 /PRNewswire/ -- New monotherapy options are needed as up to a third of epilepsy [1]patients remain uncontrolled Leading international journal, The Lancet

NovaRx Corporation announced today that the company initiated its pivotal Phase III clinical trial of Lucanix(R) (belagenpumatucel-L) in the treatment of advanced non-small cell lung cancer (NSCLC).

London, UK, 26 September 2007: BTG plc (LSE: BGC), the life sciences company, today announces that its licensee, Genzyme Corporation, and Bayer Schering Pharma AG have initiated a pivotal phase III trial of Campath® (alemtuzumab) as a treatment for multiple sclerosis. This follows the announcement of 20 September that Campath® had been approved as a first-line treatment for B-cell chronic lymphocytic leukaemia.. Louise Makin, BTGs CEO, commented: We are excited by the prospects of Campath in multiple sclerosis and delighted that the pivotal phase III trials are under way. If the excellent results from the phase II trials are reproduced, patients will have a new treatment option that has the potential to be much more efficacious than any other existing treatment.. The full text of Genzymes announcement follows.. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis. Date: September 26, 2007. Genzyme Corporation ...

This pivotal phase III trial will investigate the efficacy and tolerability of elinogrel in patients with chronic coronary heart disease and acute coronary

GREER®, a leading developer and provider of allergy immunotherapy products and services, announces that data from its pivotal Phase III investigationa

St. Jude Medical Announces First Implant in Pivotal Phase of Clinical Trial Evaluating AMPLATZER Cardiac Plug for the Prevention of Stroke in Patients with Atrial Fibrillation ST. PAUL,

Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapyNew Drug Application (NDA) submissions targeted for Q4 2021Phathom to host conference call and live webcast today, April 29, 2021 at 4:30 pm ET FLORHAM PARK, N.J., April 29, 2021 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today that in PHALCON-HP, its pivotal Phase 3 clinical trial for the eradication of H. pylori infection, both vonoprazan-based regimens successfully met their primary endpoints and met all secondary endpoints. The trial studied vonoprazan in combination with amoxicillin and clarithromycin (

Today, Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase 3 trial of the investigational microbiome-based treatment, RBX2660. These preliminary positive efficacy findings mark an important milestone, advancing RBX2660 in its clinical development program with a goal of bringing a US FDA approved therapy to patients. The clinical development program for RBX2660 is the most advanced in the world in evaluating the safety and efficacy of a standardized, non-antibiotic microbiome-based therapy.. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200506005454/en/. RBX2660 is being developed to reduce C. diff infection recurrences, an urgent unmet need for patients and healthcare providers worldwide. Antibiotics, the current standard of care, have been shown to disrupt the microbiome and increase the risk of C. diff recurrence.3C. diff causes nearly 30,000 deaths each year in the US and ...

Basel, 12 August 2015 Pivotal Phase II study of investigational medicine venetoclax met primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia Regulatory applications for...

... SAN DIEGO Mar... We are pleased to be initiating this pivotal Phase 3 trial of ZX002 a...,Zogenix,Initiates,Pivotal,Phase,3,Clinical,Trial,for,Novel,Formulation,of,Oral,Controlled-Release,Hydrocodone,medicine,advanced medical technology,medical laboratory technology,medical device technology,latest medical technology,Health

agents The long-awaited results of the pivotal phase 3 trial of denosumab proved to be AS-605240 good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral nonvertebral and hip fractures compared with placebo. remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year disease progression stopped in 8 of 10 people who received the combination therapy compared with about 6 of 10 patients who were treated with methotrexate alone. Hoping to make its own inroads in the RA market Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker AS-605240 tocilizumab (Actemra). One of the studies published in evaluated difficult-to-treat patients with moderate to severe RA who had failed previous ...

Gilead Sciences, Inc. (Nasdaq:GILD) today announced full clinical trial results from a pivotal Phase 3 study evaluating cobicistat, a pharmacoenhancing or “boosting” agent for HIV therapy, compared to ......GILD

Aimmune announces 2018 outlook, including upcoming topline data in February from pivotal Phase 3 PALISADE trial of AR101 for peanut allergy.

- Pivotal Phase 3 Top-Line Results for Bempedoic Acid Expected in the Second and Third Quarters of 2018 -- NDA Submission for LDL-C Lowering Indication for Bempedoic Acid Planned by First Quarter 2019 - ANN ARBOR, Mich., Oct. 02, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Co...

Nachricht: AbbVie Announces Positive Pivotal Phase 3 Data Demonstrating Investigational Medicine Elagolix Reduces Menstrual and Non-Menstrual Pelvic Pain Associated with Endometriosis at the American Society for - 19.10.16 - News

FREMONT, Calif., Dec. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, December 3, at 8:00 am Eastern Time to review the results from the pivotal Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease (CKD) patients on dialysis. Tenapanor is Ardelyxs investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.. To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 8065608. Live audio of the conference call and accompanying slides will be simultaneously webcast and will be available under the Investors section of the companys website at www.ardelyx.com. The webcast will be archived and available for replay for 60 days following the call.. About Ardelyx, Inc. ...

CHADDS FORD, PA. and BELLEVILLE, ON, Feb. 17- UROCIDIN™ PHASE III CLINICAL TRIAL RESULTS TO BE PRESENTED AT EAU AND AUA CONFERENCES.

Figure 3 Analysis strategies with biomarker-stratified phase III clinical trials. Freidlin, B. & Korn, E. L. ( 2013) Biomarker enrichment strategies: matching trial design to biomarker credentials Nat. Rev. Clin. Oncol. doi:10.1038/nrclinonc.2013.218. Slideshow 6861152 by chantale-scott

Evive Biotech meets primary and secondary endpoints in global Phase III clinical trial for their novel chemotherapy-induced neutropenia treatment

SAN ANTONIO and TOKYO, March 18 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. (BioNumerik) and ASKA Pharmaceutical Co., Ltd. (ASKA) today announced the results of a Phase III clinical trial of

FUJIFILM Toyama Chemical Co., Ltd. has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug

Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC ...

Trial reaches objectives of significantly reducing allergy symptom scores and anti-allergy medication use during ragweed pollen season LENOIR, N.C. June 12, 201

Top-line data from the double-blind, North American Phase III BLOOM-1 trial in 597 surgically menopausal women showed that transdermal LibiGel missed the co-primary endpoints of significantly increasing the total Read the full 293 word article

Global biotherapeutics leader CSL Behring today presented data from its Phase III PROLONG-9FP clinical program evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).

BioWorld Online is the news service of record for the biotechnology industry and is updated every business morning. BioWorld Online will keep you up to date on all of the industrys business, science and regulatory news -- mergers and collaborations, FDA hearings and results, breakthroughs in research and much more.

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Belgiums UCB has presented fresh data from a late-stage trial of its new rheumatoid arthritis compound Cimzia, in combination with methotrexate, which shows that the drug prevents structural damage to the joints. - News - PharmaTimes

Belgiums UCB has presented encouraging data from a late-stage trial of an extended-release version of its anti-epilepsy blockbuster Keppra. - News - PharmaTimes

Zealand Pharma A S (NASDAQ OMX ZEAL), a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce

Some fraction of phase I clinical trials will move on to the phase II, which seeks to answer the question as to whether the drug has, in fact, an apparent effect against the cancer in question (in our case pancreatic cancer). Many potential drug therapies go no further than phase II - as they show no real effect against pancreatic cancer. Successful phase II candidates move on to phase III clinical trials which seek to determine how the new therapy compares to existing standard therapies. Phase III clinical trials are the core measure of a potential new drug. Phase III clinical trials are controlled experiments whereby patients with similar characteristics are assigned to receive either the existing therapy or to receive the new therapy. After a time, the results of the arms of test are then compared. If the new agent shows similar or improved results as compared to existing therapy, (after another step or two) it is often approved for release by the FDA. There is even a phase IV to this process ...

Table of Contents Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our global pivotal Phase 3 clinical studies, our global pivotal Phase 3 bridging study for the bempedoic acid / ezetimibe combination, or our CVOT of bempedoic acid may occur, which may result in changes to clinical study protocols or additional clinical study requirements, which could result in increased costs to us and could delay our development timeline. Changes in regulatory requirements, FDA or EMA guidance or unanticipated events during our clinical studies may force us to amend clinical study protocols or the FDA or EMA may impose additional clinical study requirements. Significant amendments to our clinical study protocols may require resubmission to the FDA and/or IRBs for review and approval, which may adversely impact the cost, timing and/or successful completion of these studies. If we experience substantial delays completing or if we terminate any of our global pivotal Phase 3 ...

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 27, 2015. Macrocure Ltd. (NASDAQ:MCUR), announced results from a pivotal Phase 3 multicenter,

Roche announced today that a Phase III study investigating MabThera (rituximab) in combination with chemotherapy has shown a significant improvement in progression free survival in patients with relap...

Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.

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BOUDRY, Switzerland--(BUSINESS WIRE)--May. 6, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that statistical significance was achieved for the prim...

The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinsons Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process - from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinsons disease ...

Study met its primary endpoint demonstrating significant improvement in progression-free survival (PFS) with POMALYST®/IMNOVID® in combination with bortezomib and dexamethasone (PVd) compared with bortezomib and ...

CAMBRIDGE, Mass., May 31, 2011 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), today announced that 56-week data for its lead compound, lomitapide, in a pivotal Phase III clinical trial, were consistent with the data seen in the same study at 26 weeks. The single-arm, open label trial is designed to evaluate the efficacy and long-term safety of lomitapide for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). HoFH is a rare and often fatal condition characterized by severely elevated levels of low-density lipoprotein cholesterol, or LDL-C, leading to life-threatening cardiovascular events. Lomitapide has been designated by FDA as an orphan drug to treat this condition. The data show that lomitapide reduced cholesterol substantially in patients with HoFH.

Therapeutic area data reported by biopharma companies on phase III trials in February 2020, including: Abbvie, Acucela, Adamas, Allecra, Alnylam, Amgen, Ampio, Arcutis, Astellas, Axsome, Bayer, Biohaven, BMS, Breath, Citius, Crescita, Eli Lilly, Exelixis, Foamix, Genentech, Genfit, Gilead, Incyte, Ionis, Janssen, Kowa, Marinus, Merck, Minerva, Myovant, Novan, Pfizer, Polyphor, Polypid, Proteostasis, PTC, Rebiotix, Sanifit, Scynexis, Servier, Takeda, Teva, Tonix, Vanda, Zynerba.

LAWRENCEVILLE, NJ -- (Marketwire) -- 05/30/12 -- Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has reached its enrollment objective of 700 pa...

Phase I (one) medical and clinical trial recruitment. Volunteer to join trials or advertise a clinical trial or medical study on MedTrials.

OCA Meets Primary Endpoint With High Statistical Significance of p , 0.0001. -Company to Conduct Conference Call and Webcast March 17, 2014 at 8:30 a.m. ET. NEW YORK, March 16, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that its international Phase 3 POISE trial of obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC) demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trials primary endpoint of achieving a reduction in serum alkaline phosphatase (ALP) to , 1.67x ULN with a ≥ 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group (both dose groups p , 0.0001 vs placebo) in an intention to treat analysis. The placebo group experienced a mean decrease in ALP from baseline of 5%, compared to a significant ...

Novartis International AG / Phase III data shows Sandoz' proposed biosimilar pegfilgrastim has similar safety and efficacy as the reference product . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Ceftazidime-avibactam is being developed with Astra Zeneca jointly. Forest Laboratories LLC., a subsidiary of Actavis plc, holds the rights to commercialize ceftazidime-avibactam in North America, while AstraZeneca holds the privileges to commercialize ceftazdime-avibactam in the rest of the global world.. Actavis reports excellent results from ceftazidime-avibactam Phase III studies in cIAI patients Actavis plc today confirmed positive topline results from RECLAIM-1 and -2, pivotal Phase III studies evaluating the prospect of the investigational antibiotic, ceftazidime-avibactam as a treatment for adult hospitalized sufferers with complicated intra-abdominal infections. Ceftazidime-avibactam includes a cephalosporin , an established treatment for significant bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor .This system appears to be more essential than those earlier described for prolonged stimulation by dopamine, as would be the case in those with ...

Update on Paroxysmal Nocturnal Hemoglobinuria (PNH) Long Term Safety Study Shows 100% Transfusion Independence Two-part pivotal Phase III study of nomacopan in pediatric.

STOCKHOLM - December 7, 2019 - Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019. Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study. These data reinforce Oncopeptides view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020.

Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting

CORAL GABLES, Fla., March 25, 2014 (GLOBE NEWSWIRE) -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on developing safe and effective approved medicines targeting orphan neuromuscular and neurological diseases, announced today that, at a recently held meeting, the independent Data Monitoring Committee (DMC) overseeing the Companys ongoing pivotal Phase 3 clinical trial evaluating Firdapse™ for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) recommended that the trial be continued as planned based on the committees review of safety and clinical data from the trial.

WOCKHARDT RECEIVES ACKNOWLEDGEMENT OF ITS BREAKTHROUGH SUPERDRUG ANTIBIOTIC WCK 5222 FOR PHASE III CLINICAL TRIAL FROM US FDAIn a recent meeting between Wockhardt Research team and US FDA New Drug Antibiotic Regulatory team, US FDA agreed to abridged

Aurinia Announces Plans For Single Phase III Clinical Trial For Voclosporin In The Treatment Of Lupus Nephritis Following Successful Completion Of End Of Phase II Meeting With FDA - read this article along with other careers information, tips and advice on BioSpace

GlaxoSmithKline plc (GSK,GSK.L) announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix in preventing shingles when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant. Shingrix is a non-live, recombinant adjuvanted subunit vaccine.. The study succeeded in its primary objective by demonstrating an efficacy of 68.17%. The vaccine reduced overall complications linked to shingles episodes by 77.76%. No safety issues related to the vaccine were detected during the study. GSK said it is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. Shingrix is now approved in Canada and US for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan. by RTT Staff Writer. For comments and feedback: [email protected] Business News ...

TY - JOUR. T1 - Depressive distress among the spouses of terminally III cancer patients. AU - Siegel, Karolynn. AU - Karus, Daniel G.. AU - Raveis, Victoria. AU - Christ, Grace H.. AU - Mesagno, Frances P.. PY - 1996/1/1. Y1 - 1996/1/1. N2 - Bereaved spouses comprise a population at risk for psychological distress. Evidence suggests that spouses 55 years of age and younger are at increased risk of morbid outcomes, including major depressive episodes. Although the emotional impact of the sudden loss of a spouse has been well studied, less attention has been paid to the psychological impact of loss that is foreseeable, as in the case of a serious illness. In this study, data were obtained from pre-death interviews with 103 well spouses of terminally ill cancer patients. Subjects were white, 55 years of age or younger, and living with the patient and their child(ren) aged 7 to 16 years old. Depressive distress was assessed using the Brief Symptom Inventory. Fifty eight percent of males and 42% of ...

Sanofi reports that the first patient outside of the US has been treated as part of a global clinical program evaluating Sanofis and Regeneron Pharmaceuticals Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the US, all countries that have been impacted by COVID-19. Sanofi is leading trials outside the US while Regeneron is leading US trials.. This is the second multi-center, double-blind, Phase II/III trial as part of the Kevzara COVID-19 program, and the companies say that they are continuing to work with authorities around the world to secure initiation at additional sites. This follows Sanofi and Regenerons earlier announcement of the initiation of the first trial, which is US-based.. Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive ...

Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks ...

This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung

Summary: Naturally occurring mutations in the hepatitis C virus (HCV) are common and many lead to reduced efficacy of antiviral treatments. Faldaprevir* has now been shown to be effective even in patients with the common HCV Q80K variant,1 which affects an estimated 700,0002,3,4 patients in the USA alone. Faldaprevir* is being studied in combinations both with and without interferon. The EMA recently granted accelerated assessment for faldaprevir* as part of an interferon-based regimen and a decision on marketing authorisation is anticipated next year.5,6. For media outside of the US, the UK & Canada only. INGELHEIM, 16 December, 2013 - Data show that Boehringer Ingelheims second-generation protease inhibitor faldaprevir*, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus (HCV), such as the NS3 Q80K polymorphism. The Q80K mutant was detected in 23% (49/127, STARTVerso™1) and ...

HATFIELD, England, October 15, 2015 /PRNewswire/ -- - INVITATION FOR EUROPEAN AND ASIAN

M.D., Ph.D., senior vice president, global development and chief development officer at Ironwood.Pre-clinical and clinical evidence suggest that IW-3718 may offer a treatment option for the millions of patients with GERD who continue to experience frequent and bothersome symptoms such as heartburn and regurgitation despite taking PPIs. Our teams have done excellent work to rapidly initiate these trials. We are hopeful that these studies will generate data in support of a potential approval as quickly as possible. The Phase III program comprises two identical randomized, double-blind, placebo-controlled, multicenter Phase III trials that target enrolling approximately 1,320 patients total (660 in each trial) with persistent GERD who demonstrate evidence of pathological acid reflux. Eligible patients will continue to take PPIs and be randomized to placebo or IW-3718 1500 mg twice a day for eight weeks. The primary endpoint is overall heartburn responder, defined as a patient who experiences at ...

The Phase III RESIST (Randomized Evaluation of Strategic Intervention in Multi-Drug ReSistant Patients with Tipranavir) clinical trial program has been designed to study the safety and efficacy of tipranavir (boosted with low-dose ritonavir) versus a low-dose ritonavir-boosted comparator protease inhibitor (PI) that is chosen by the patients physician on the basis of treatment history and baseline resistance testing. Study participants will all be highly treatment-experienced HIV-positive adults. Phase III of clinical development is the final stage of testing before a drug is submitted to worldwide regulatory authorities for review and consideration for marketing approval. The RESIST Program consists of two Phase III pivotal trials (RESIST 1 and RESIST 2) and two companion trials (study 1182.51 and RESIST 3) available for even more advanced patients ...

Analyses of pivotal study data of Dysport® reveal a large proportion of study patients did not require retreatment for at least 12 weeks (and at least 16 weeks for pediatric upper limb spasticity) This new analysis concluded that Dysport® is associated with a long duration of response These data form one of 26 abstracts Ipsen […]

Read about how Teva Pharmaceuticals investigational treatment for migraine prevention was able to reduce the number of migraine days per month in a recent Phase III clinical trial.

Below is a look at some of the headlines for companies that made news in the healthcare sector on July 11, 2013. Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the

This resource center is for patients and families coping with cancer and interested in learning about clinical trials for the disease. You can find information here on how clinical trials are structured and managed, how to find and evaluate clinical trials, how eligibility to participate is determined, the ethics of conducting clinical trials, special types of clinical trials, and financial issues related to clinical trials.

Following these, two additional analyses for OS are planned: a second interim analysis and a third and final OS analysis.. With 630 patients, the SYMMETRY trial is over 95% powered to detect a statistically significant improvement in PFS. Secondary endpoints in addition to overall survival include response rate, clinical benefit rate (defined as complete response, partial response, or stable disease at 24 weeks), and duration of response. Projections and powering assumptions are based on detecting an improvement of two months in PFS (67%, hazard ratio 0.60), or three months in OS (33%, hazard ratio 0.75).. Based on our current enrollment and event rate projections, Synta expects to complete the primary endpoint analysis by the end of 2008 and file a New Drug Application (NDA) with the Food and Drug Administration (FDA) by the first half of 2009.. The SYMMETRY trial is now open for patient recruitment. For those interested in more information about the trial, please visit centerwatch.com/SYMMETRY ...

This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (Regeneron or the Company), and actual events or results may differ materially from these forward-looking statements. Words such as anticipate, expect, intend, plan, believe, seek, estimate, variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regenerons products, product candidates, and research and clinical programs now underway or planned, including without limitation sarilumab; ongoing regulatory obligations and oversight impacting Regenerons marketed products, research and clinical programs, and business, ...

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA™ (daclizumab high-yield process), dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis (RRMS) compared to AVONEX® (interferon beta-1a).

May 19, 2004. The U.S. Food and Drug Administration has granted approval of Gemzar® (gemcitabine HCl), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer.. The FDAs approval marks the second indication in 2004 for a Lilly Oncology drug, and for Gemzar, specifically; this is the drugs third indication in the United States.. The approval of the Gemzar/Taxol combination was granted following analysis of Phase III data, which demonstrated superior treatment outcomes. Patients diagnosed with metastatic breast cancer and treated with a combination of Gemzar and Taxol experienced a significant delay in the improvement in time to disease progression of their disease and response rate compared to Taxol alone. The time to disease progression data (5.2 months vs. 2.9 months, respectively; p,0.0001) were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2003. Survival results will be ...

AbbVie (NYSE: ABBV), a global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that data...

There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concurrently across a number of different biomarker-defined population-enriched cohorts: BRAF mutation; activated AKT pathway: PI3K mutation/absolute PTEN loss tumors; KRAS and NRAS mutations; and wild type at all the

October 2, 2015.. We are delighted to announce that the HiP trial is fully up and running and has dosed its 15th patient. This multi-center, randomized controlled trial is being led by Cork University Hospital and is being conducted in several centers in Europe and Canada. We expect to enroll approximately 750 babies.. About 150,000 pediatric patients, mostly newborn babies and infants, are treated for hypotension in Europe each year. Hypotension can occur as a result of any one of a number of conditions. Those conditions are often life-threatening and require urgent treatment. Currently, pediatric patients are treated with drugs that are not specifically approved for children and are supplied in a form that is appropriate for an adult.. The purpose of the trial is to further refine the optimal treatment protocols for this vulnerably population and it will lead to the development of an age-appropriate dosage form of the most commonly used drug for treating hypotension in pediatric patients. The ...

OncologyPRO is the home of ESMOs educational & scientific resources, with exclusive content for ESMO members such as ESMOs Congresses webcasts,

Bachem and ISA Pharmaceuticals B.V. today announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceuticals immunotherapeutic HPV-SLP® product. Press Release. ...

Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, Inclusive and open to diversity, innovation oriented to win together and benefit the mankind, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and ...

Motif chief executive Graham Lumsden told investors: Resistance to antibiotics is a major global health threat and we believe that iclaprim, a novel antibiotic in the under-utilized dihydrofolate reductase inhibitor class, can become an integral part of hospital doctors life-saving treatment strategies. ...

Complement refers to a cascade of inter-related proteins that are important in defending our bodies against a wide range of bacteria. Over our lifetimes, our bodies have learned to recognize certain markers (antigens) on bacteria and developed antibodies (immunoglobulins) that are specific to each of these antigens. As soon as one of these known bacteria is seen, the antigens on the surface of the bacteria are quickly tagged by the corresponding antibody molecules circulating in our blood. The presence of these antigen-antibody pairs on the surface of the microbe are like neon advertising signs that attract complement proteins to swoop down and kill the cell. I hope you can see the parallel between this scenario and what happens when we treat a CLL patient with a man-made anti-CD20 monoclonal antibody. Here the hapless B-cell is in the role of the bacterium, the CD20 marker it carries is the antigen and the man-made monoclonal antibody drug is the synthetic immunoglobulin that mates with the ...

A group of researchers at Osaka University developed a synthetic tissue using synovium-derived mesenchymal stem cells (MSCs) for treating damaged cartilage, which had previously been incurable and had no effective therapies.

The IMbrave150 study combination immunotherapy, with the PD-L1 inhibitor atezolizumab and the VEGF inhibitor bevacizumab, has proven positive results by enhancing the potential of the immune system to combat Hepatocellular Carcinoma (HCC) among Asian patients

RATIONALE: Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells or by sto

Hi i am new to this site but my husband went in with a seizure in late September of this year and before we knew it within 3 days there was a biopsy preformed and then a few days to follow he was being scheduled for a craniotomy! he is 36 and we have 3 children (12, 10 ,1) fear isnt even the world to being to describe what we both were feeling for each other and our children. We live in buffalo ny and he is now an official patient of Roswell which is not far from our house at all. he was dignaised with AA3 in his right frontal lobe they were able to remove 90% of the tumor he followed up with radiation and chemotherapy pill form and had very little to none of the side effects. He did lose his hair but thats the least of his problems and something that is very managable (bald is beautiful ) we have lucked out so far if thats even a thing with something this devastating but he is able to function 90 percent of his body and uses a cane as he had to reteach his left side to move Simultaneously ...

DARMSTADT, Germany and NEW YORK, November 28, 2017 /PRNewswire/ -- Not intended for UK-based media - Pivotal Phase III Javelin trial investigating

A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC). ...

Amgen and Novartis will expand their collaboration with the Banner Alzheimers Institute by launching a new Phase II/III trial designed to assess whether the oral BACE1 inhibitor CNP520 codeveloped by the companies can prevent or delay symptoms in people at high risk for the disease

* 24-month update on Phase III data comparing Tasigna to Glivec in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase, , , , * Afinitor plus hormonal therapy stud...

Atacicept, a biologic agent that targets two B-cell factors in patients with moderate-to-severe lupus, failed to meet the primary endpoint in a yearlong phase II/III trial, researchers reported.

Comprehensive analyses of pooled data from three randomized, double-blind, placebo-controlled Phase II/III trials showing the efficacy and tolerability of Vimpat® (lacosamide) C-V for...