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,
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
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 ...
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 ...
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 ...
With up to six years of follow-up, results from the RESONATETM study showed patients with previously treated CLL receiving ibrutinib monotherapy sustained progression-free survival and overall survival benefits versus ofatumumab[1]Five-year follow-up data from the RESONATETM-2 study showed sustained progression-free...
Breast cancer is the most common cancer among women, accounting for about one-third of all cancers in women. A recent phase III clinical trial was directed to explore the effectiveness and efficacy of two drug combinations that target HER2 amplification.
SAN DIEGO, Sept. 8, 2015-- Neothetics, Inc., a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. The enrollment was completed on schedule, and we are on track for data by end of this calendar year, said George Mahaffey, President and Chief Executive...
DUBLIN, IRELAND--(Marketwired - Sep 7, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) Statistically Significant Benefits in Lung Function, Health-Related Quality of Life and Annual Rate of Exacerbations Observed for Closed Triple as Compared to Symbicort® Turbohaler® Theravance Biopharma Entitled to Receive 85% Economic Interest in Closed Triple Royalties Paid by...
Data Sets Demonstrating Efficacy and Quality of Life Profile of SILIQ Presented at 2017 Fall Clinical Dermatology ConferenceLAVAL, Quebec, Oct. 12, 2017 /CN...
Path: hivnet.org!fido.hivnet.org!aegis.hivnet.org!Mary_Elizabeth ,Newsgroups: hiv.aids.data Distribution: hivnet Date: Wed, 25 Jan 95 06:38:39 +0100 From: Mary_Elizabeth at aegis.hivnet.org Reply-To: Mary_Elizabeth at aegis.hivnet.org Subject: ONCONASE ENTERS PHASE III FOR PANCREATIC Comment-To: All at f927.n103.z1.fido.hivnet.org Message-ID: ,f26af136 at f927.n103.z1.fido.hivnet.org, X-Fidonet-Comment-To: Mary_Elizabeth at aegis.hivnet.org X-FSC-PATH: 103/927 280/413 Lines: 26 Document 165 DOCN AD950165 TI ONCONASE Enters Phase III for Pancreatic Cancer DT 950124 SO Business Wire (01/24/95) AB Alfacell Corp. announced on Tuesday that it will commence Phase III clinical trials for ONCONASE, which is being tested in combination with tamoxifen to treat pancreatic cancer. The FDA approved the companys Phase III protocol design--which calls for a randomized, multi-center trial--on Jan. 23. ONCONASE has been established as a novel enzyme in both structure and function, and is now recognized as the ...
In order to ensure a regular safety monitoring of patients enrolled in ReLive, the organization of a Board of international experts was to meet every 6 months, and/or after inclusion of the first 25 patients, to review the safety data of patients included in the trial, and to recommend possible modifications of the protocol. This type of Board is usually organized in pivotal phase III clinical trials to assure patient safety and integrity of the trial ...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. ...
This trial will evaluate the efficacy and tolerability of AGSCT 101 and carvedilol in patients with stage 1 to 2 essential hypertension. The primary outcome is
PIII We believe the totality of Phase III data suggest a strong benefit-risk profile All Cohorts Endpoint How Endpoint is Measured Results Complete Response Rate (CRR) • 40% CRR at 3 months Defined as the proportion of patients who show no evidence of high-risk Primary Endpoint • Lower bound of 95% CI rules out clinically unmeaningful CRR disease, or disease progression (e.g., T2 or more advanced disease). CIS patients • Higher complete response rate in patients receiving less BCG Duration of Response (DoR) • 52% duration of 9 months (12 months of therapy) Primary Endpoint Defined as the time from complete response to treatment failure. • 39% duration of 15 months or greater (18 months of therapy) CIS patients • The longer the CR, the higher the probability of remaining disease-free Time to Disease Recurrence • Median time to recurrence is 402 days Defined as the time from the date of first dose of study treatment to treatment Secondary Endpoint • 50% probability of remaining ...
PIII We believe the totality of Phase III data suggest a strong benefit-risk profile All Cohorts Endpoint How Endpoint is Measured Results Complete Response Rate (CRR) • 40% CRR at 3 months Defined as the proportion of patients who show no evidence of high-risk Primary Endpoint • Lower bound of 95% CI rules out clinically unmeaningful CRR disease, or disease progression (e.g., T2 or more advanced disease). CIS patients • Higher complete response rate in patients receiving less BCG Duration of Response (DoR) • 52% duration of 9 months (12 months of therapy) Primary Endpoint Defined as the time from complete response to treatment failure. • 39% duration of 15 months or greater (18 months of therapy) CIS patients • The longer the CR, the higher the probability of remaining disease-free Time to Disease Recurrence • Median time to recurrence is 402 days Defined as the time from the date of first dose of study treatment to treatment Secondary Endpoint • 50% probability of remaining ...
COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial (
In February 2016 OBI announced that top-line data of the phase 2/3 metastatic breast cancer study did not meet the primary endpoint of progression-free survival. Results were presented in June at ASCO 2016 in Chicago. But, as patients who did show an immune response demonstrated statistically significant progression-free survival versus placebo, coupled with the secondary endpoint of overall survival trending towards statistical significance and no safety issues reported, OBI noted in their February 2016 press release that they expected to forge ahead with a phase III study. Then in a January 20, 2017 press release OBI announced that they met with the FDA for its end-of-phase II meeting and "based on the discussion with the FDA, OBI Pharma plans to prepare its phase III protocol". Just days later (January 24) OBI announced that they received approval from the China FDA to conduct a phase III clinical trial of OBI-822 which OBI notes can be used in a future BLA application ...
Chelsea Therapeutics International, Ltd. (CHTP) said Thursday that all corporate officers and directors of the company will take a voluntary 25% reduction in salary and fees, respectively, effective July 1, until the results of the companys ongoing Phase III trial of Northera are available, currently estimated to be during the first quarter of 2013.
Data from the interim analysis of the on-going PATENT-2 trial with Riociguat, the open-label long-term extension of the pivotal Phase III study PATENT-1, were presented at the American Thoracic Societ ... read article ...
On Monday, Sanofi said a second late-stage Phase III study of its LixiLan diabetes drug had met its key target. This success has made it all set for regulatory submissions by the fourth quarter in the United States and the first quarter of next year in the European Union.. LixiLan includes a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma, and Sanofis Lantus. It is aimed at patients with type-2 diabetes.. In a statement, the French drugmaker said the full results will be communicated in a future scientific forum.. The French drugmaker said that the LixiLan-L Phase III clinical trial has achieved its primary endpoint in patients with type 2 diabetes, who went under treatment with insulin glargine with or without metformin.. ...
mNaNO3 mNH4NO3 t solid ref. weight 9.0952 0.0000 0.00 2 a(2164) - 7.7585 13.1713 0.00 2 a(2164) - 7.7585 13.1713 0.00 12 a(2164) - 0.0000 14.7906 0.00 12 a(2164) - 9.8701 0.0000 15.00 2 a(2164) - 9.5494 2.9990 15.00 2 a(2164) - 9.3323 5.3475 15.00 2 a(2164) - 9.1794 8.0682 15.00 2 a(2164) - 8.9185 13.8544 15.00 2 a(2164) - 8.8587 18.9811 15.00 2 a(2164) - 8.8639 19.3945 15.00 12 a(2164) - 7.1442 19.4938 15.00 12 a(2164) - 4.2925 19.8564 15.00 12 a(2164) - 3.2706 19.9857 15.00 12 a(2164) - 2.0745 20.2697 15.00 12 a(2164) - 0.0000 20.9112 15.00 12 a(2164) - 11.3085 0.0000 30.00 2 a(2164) - 10.3843 27.5772 30.00 2 a(2164) - 10.3843 27.5772 30.00 12 a(2164) - 0.0000 29.0541 30.00 12 a(2164) - 621.21 1826.52 140.00 2 a(2165) - 621.21 1826.52 140.00 14 a(2165) - 275.83 1082.75 117.00 2 a(2165) - 275.83 1082.75 117.00 13 a(2165) - 39.2180 154.0838 95.00 2 a(2165) - 39.2180 154.0838 95.00 13 a(2165) - 15.4325 52.2446 60.00 2 a(2165) - 15.4325 52.2446 60.00 11 a(2165) - 11.4918 33.4123 40.00 2 a(2165) - ...
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplasti
Over the several clinical experiences with CF101 for RA, Can-Fite has learned and identified the relationship between A3AR expression and response for CF101. Based on these findings, the companys last Phase IIb trial demonstrated positive data of CF101 for the treatment of RA patients based on the level of A3AR expression. The planned Phase III trial uses the same criteria for screening RA patients, and therefore has a high possibility that it will replicate the results of the last Phase IIb trial. ...
Examine the study design of the pivotal Phase 3 trial and long-term extension study of VIMIZIM® (elosulfase alfa) in patients with Moquino A. View boxed warning, including risk of anaphylaxis.
Imetelstats study in MF will reportedly continue unchanged, keeping the hope alive that this drug will ultimately garner multiple indications in the high-value hematology space. If so, it should turn out to be a blockbuster product. Additionally, J&J and Geron said that the second part of imetelstats other trial in MDS will be submitted for refinements to the FDA. And if all goes according to plan, imetelstat could be in the pivotal phase of its trial for MDS by the fourth quarter of this year. The key takeaway is that imetelstat is starting to look like the real deal. So, while its probably prudent to remain cautious with this small-cap biotech, it might be a good idea to start grabbing at least a few shares in case imetelstat does beat the odds and somehow lives up to the lofty expectations of J&J and Geron. ...
Genentech, a member of the Roche Group, said it will terminate two Phase III trials assessing its Alzheimers disease candidate crenezumab, adding to the list of candidates that have failed clinical studies in the memory-robbing ailment.
Zogenix, Inc. (ZGNX), a global pharmaceutical company developing rare disease therapies, and its wholly-owned subsidiary, Modis Therapeutics, presented positive top-line results from its pivotal Phase 2 RETRO study at the recent World Muscle Society congress in Copenhagen. The data from RETRO form
Conclusions: Holding onto a quick fix is a pivotal phase whereby supports, such as engagement in realistic goal setting, are essential to facilitate family members resolution of driving disruption issues. Family members who see no way out might not actively seek help and these points to a need for long-term and regular follow-ups. Future research can explore ways to support family members at these key times ...
Janssen Research & Development, LLC (Janssen) has announced findings from the first of three pivotal Phase 3 studies evaluating guselkumab, a subcutaneously administered anti-interleukin...
JERUSALEM--(BUSINESS WIRE)--Jan. 22, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registrati, Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma
JERUSALEM--(BUSINESS WIRE)--Jan. 22, 2018-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that a Phase III registrati, Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma
The hot roll for biotech continued today, with InterMune reporting positive Phase III clinical trial results for its drug pirfenidone
Alcon Incorporated. Protocol C-02-60 information for potential participants about a phase III clinical trial to evaluate an investigational treatment for stopping the progression of dry AMD to wet AMD [online]. Available from URL: http://www.alconlabs.comlus/eo/clinicalstudies/ [Accessed 2005 Feb 21] ...
The Partners PrEP Study is a double-blind, placebo-controlled, phase III clinical trial aimed to assess the safety and efficacy of oral PrEP for the... ...
WOODCLIFF LAKE, N.J. - Eisai Inc. announced July 9 preliminary results from a recently completed phase III study of Halaven versus capecitabine (Xelo
A method of detecting an end point of polishing arranged to perform CMP polishing with which an insulating layer of a wafer incorporating a substrate having a metal-containing permalloy layer formed thereon and the insulating layer formed on the metal-containing permalloy layer is chemimechanically polished to expose the flat permalloy layer, the method of detecting an end point of polishing, having the steps of: collecting abrasive material slurry on a surface plate for polishing as a continuous flow from the start or during CMP polishing; continuously mixing a color developing reagent with the collected continuous flow to prepare a specimen for the continuos flow; reading the color of the specimen as a digital value (Ii) by a color identifying sensor; and determining a moment of time at which the digital value (Ii) reaches a digital value (Io) of a specimen of a waste flow of the abrasive material slurry at the end of polishing to be the end of CMP polishing.
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.
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 ...
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
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 ...
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 ...
--Two-Year Data from RISE and RIDE Studies Presented at the American Diabetes Association Annual Scientific Sessions -- SAN DIEGO--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO,
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).
AbbVie (NYSE: ABBV), a global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that data...
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 ...
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. ...
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." ...
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.
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
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.