primary endpoint

Type: Keyphrase
Name: primary endpoint
First reported 11 mins ago - Updated 11 mins ago - 1 reports

Sanofi and Regneron say Phase III alirocumab trials met primary endpoint

French drug major Sanofi (Euronext: SAN) and USA-based biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) have announced that nine new Phase III ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint.Alirocumab ... [Published Pharma Letter - 11 mins ago]
First reported 22 hours ago - Updated 5 hours ago - 1 reports

Quark's RNAi treatment misses the mark in a Phase II kidney trial

Quark Pharmaceuticals' gene-silencing treatment for kidney transplant complications missed its primary endpoint in a Phase II trial, possibly jeopardizing a deal with Novartis ($NVS) worth up to $680 million.The treatment, QPI-1002, is a small interfering ... [Published FierceBiotech - 22 hours ago]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

FDA Rejects Sublingual Sufentanil for Pain Relief

News Categories Delivery device questionedThe FDA has rejected the new drug application (NDA) for Zalviso (sufentanil sublingual tablet system).The agency’s complete response letter (CRL) contained requests for additional information on the Zalviso System ... [Published P&T Community - Jul 28 2014]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

Progen cancer drug fails Phase 3

07:32 ET | About: Progen Pharmaceuticals Ltd. (PGLA)Progen Pharmaceuticals' (OTCQB:PGLA) candidate for the adjuvant treatment of hepatocellular carcinoma after surgical resection, PI-88, failed to achieve its primary endpoint of Disease Free Survival ... [Published Seeking Alpha - Jul 28 2014]
First reported Jul 25 2014 - Updated Jul 26 2014 - 20 reports

Nexavar fails to meet primary endpoint in HER-2–negative breast cancer

Results from a phase 3 trial have found that sorafenib plus capecitabine did not meet its primary endpoint of improving PFS for the treatment of locally advanced or metastatic HER-2–negative breast cancer, manufacturers Bayer HealthCare Pharmaceuticals ... [Published Orthopedics Today - Jul 26 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 1 reports

Celgene announces phase 3 results for Otezla

The oral phosphodiesterase 4 selective inhibitor, Otezla, did not meet the primary endpoint of the POSTURE study but did achieve meaningful efficacy by week 24, according to a company press release.Otezla (apremilast, Celgene) was approved by the U.S. ... [Published Orthopedics Today - Jul 25 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 2 reports

Biotech Stock Mailbag: Intercept Pharma, Inovio

07/25/14 - 07:31 AM EDTBOSTON ( TheStreet ) -- Let's kick off this week's Biotech Stock Mailbag with a discussion about human foie gras."Velop45" asks: "Adam, I appreciate you keeping us on top of biotech events but I was hoping to hear more from you ... [Published TheStreet.com - Jul 25 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

Inovio Pharma's Immunotherapy for Cervical Dysplasia Meets Goal

Reuters Health InformationBy Reuters StaffJuly 24, 2014(Reuters) - Inovio Pharmaceuticals Inc announced positive results from its randomized, double-blind, placebo-controlled phase II trial of VGX-3100 in women with biopsy-proven cervical intraepithelial ... [Published General Medicine eJournal - Jul 24 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

UPDATE: Keryx Announces Zerenex LT Phase 3 Results Shows 'Highly Statistically Significant' Change, Met Primary Endpoint

at 17:04 PM EDT Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") announced the publication of results from the long-term, randomized, ...Related Stocks ... [Published Fat Pitch Financials - Jul 24 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

Exciting IPF Treatment News Must Be Interpreted Cautiously

This is Andy Shorr from Washington, DC, with a pulmonary critical care literature update. I want to point out 3 articles about idiopathic pulmonary fibrosis (IPF) that were all in the May 29 issue of the New England Journal of Medicine . [1-3]As you ... [Published General Medicine eJournal - Jul 24 2014]
First reported Jul 23 2014 - Updated Jul 23 2014 - 2 reports

Inovio's HPV Immunotherapy Hits Primary Endpoint

Inovio Pharmaceuticals Inc. announced successful results from its randomized, double-blind, placebo-controlled Phase 2 trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3) associated with human papillomavirus (HPV) ... [Published Drug Discovery and Development - Jul 23 2014]
First reported Jul 23 2014 - Updated Jul 23 2014 - 1 reports

Puma Pumps up Biotech ETFs

Shares of Puma Biotechnology (NYSE: PBYI) are up more than 277% Wednesday on volume that is already better than 10 times the daily average after the company said its experimental breast cancer treatment, neratinib, proved successful in a Phase III trial. ... [Published Street Sweeper - Jul 23 2014]

Quotes

Elias Zerhouni, president of global R&D at Sanofi, said: "The robust data from these studies in more than 5,000 patients is the basis of our global regulatory submissions, which we expect in the US and EU by year end. We look forward to potentially providing a new treatment option for patients who may need a more aggressive cholesterol-lowering treatment on top of standard of care."
...Elias Zerhouni, president of global R&D at Sanofi, said "the robust data from these studies in more than 5000 patients is the basis of our global regulatory submissions, which we expect in the US and EU by year end."
...dosed with AtuRNAi, there is further valuable data to add to the safety record we already have," said Chief Executive Ali Mortazavi in a statement. "We are excited about the potential of AtuRNAi in this application and the progression of our IP toward commercial therapeutics."
"We have also seen some clinical activity and efficacy in this study, confirming the clinical utility of our technology.” "

More Content

All (1141) | News (950) | Reports (0) | Blogs (164) | Audio/Video (0) | Fact Sheets (1) | Press Releases (17)
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Sanofi and Regneron say Phase III alirocumab tr... [Published Pharma Letter - 11 mins ago]
Sanofi, Regeneron say PCSK9 inhibitor alirocuma... [Published FirstWord Pharma - 2 hours ago]
Sanofi, Regeneron drug cuts cholesterol in nine... [Published CNBC - 3 hours ago]
Baylor Sammons Cancer Center Joins as Clinical ... [Published Wall Street Select - 4 hours ago]
Stivarga (regorafenib) from Bayer Approved in t... [Published FirstWord Pharma - 5 hours ago]
Silence Therapeutics : Licensee Sees Favourable... [Published 4 Traders - 5 hours ago]
Silence Therapeutics : Quark Confirms Favourabl... [Published RTTNews.com - 6 hours ago]
Silence Therapeutics encouraged by kidney disea... [Published Proactiveinvestors United Kingdom website - 8 hours ago]
Silence Therapeutics says favourable trial for ... [Published Stock Market Wire - 8 hours ago]
Silence Therapeutics : Licensee confirms favour... [Published Investegate - 9 hours ago]
Amgen (AMGN) CEO Bob Bradway on Q2 2014 Results... [Published Seeking Alpha - 13 hours ago]
FDA approves EYLEA Injection for treatment of D... [Published News-Medical.Net - 13 hours ago]
Endocyte's (ECYT) CEO Ron Ellis on Q2 2014 Resu... [Published Seeking Alpha - 14 hours ago]
EYLEA® (aflibercept) Injection Receives FDA App... [Published The CW44 Tampa Bay - 17 hours ago]
Fate Therapeutics Announces FDA Clearance of IN... [Published Crawford Financial Planning - 19 hours ago]
Survival equivalent with cetuximab or bevacizum... [Published Chemotherapy Advisor - 20 hours ago]
Quark's RNAi treatment misses the mark in a Pha... [Published FierceBiotech - 22 hours ago]
Merck Serono Kicks Off Study of Merkel Cell Car... [Published Drug Discovery and Development - 22 hours ago]
New Study Evaluates Efficacy of Combined Stent ... [Published Diagnostic & Invasive Cardiology - 22 hours ago]
ACS Antithrombotics: Back to the Future? [Published General Medicine eJournal - Jul 29 2014]
Topical tamoxifen noninferior to oral formulati... [Published Orthopedics Today - Jul 29 2014]
Glucose control in intensive care: usability, e... [Published 7thSpace - Jul 29 2014]
Glucose control in intensive care: usability, e... [Published BMC - Jul 29 2014]
Prosensa Holding NV (NASDAQ:RNA) Investor Alert... [Published SBWire - Jul 29 2014]
published on: 29 July, 2014 Roche's Gazyvaro ap... [Published Roche - Jul 29 2014]
Hair-sparing whole brain radiotherapy with volu... [Published 7thSpace - Jul 29 2014]
Merck Serono initiates phase II study of Anti-P... [Published Express Pharma - Jul 29 2014]
European Commission Approves Roche's Gazyvaro F... [Published RTTNews.com - Jul 29 2014]
Roche’s Gazyvaro approved in Europe for patient... [Published European Pharmaceutical Review - Jul 29 2014]
Merck Serono Initiates Phase II Study of Anti-P... [Published Asia PR News - Jul 29 2014]
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Blogs

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Silence Therapeutics encouraged by kidney disea... [Published Proactiveinvestors United Kingdom website - 8 hours ago]
RNA interference specialist Silence Therapeutics ’s ( LON:SLN ) treatment for delayed graft function in kidney transplants has been shown to be beneficial and tolerated in a phase II trial. Licence holder Quark Pharmaceuticals carried out the trial ...
[Comment] Alemtuzumab induction therapy in kidn... [Published The Lancet online - Jul 28 2014]
In The Lancet, Peter Friend and the 3C Study Collaborative Group report the results of the first part of the 3C Study—an open-label, randomised, multicentre study of alemtuzumab compared with basiliximab induction treatment, followed by sirolimus versus ...
Promising Cancer Drug Fails to Slow Breast Cancer [Published TIME.com - Jul 25 2014]
A Phase 3 trial of cancer drug Nexavar in patients with advanced breast cancer failed to delay progression of the disease, according to the drug’s makers, Bayer and Onyx Pharmaceuticals, Inc., an Amgen subsidiary. The study, called Reslience, evaluated ...
Phase III Trial of Sorafenib in Combination wit... [Published Bayer Corporate News - Jul 25 2014]
Incyte Announces Top-Line Results from RELIEF T... [Published EON Science - Jul 23 2014]
WILMINGTON, Del.--(EON: Enhanced Online News)--Incyte Corporation (Nasdaq: INCY) today announced top-line results from RELIEF, a randomized, double-blind clinical trial designed to compare symptom improvement in 110 patients with polycythemia vera (PV) ...
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Press Releases

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Sanofi and Regeneron Announce Positive Results ... [Published GlobeNewswire: Acquisitions News - Jul 09 2014]
GSK and Genmab announce top-line results from a... [Published GlobeNewswire: Advertising News - Jun 27 2014]
Lundbeck provides update on the development pro... [Published GlobeNewswire: Acquisitions News - Jun 27 2014]
DGAP-News: PAION REPORTS POSITIVE PHASE II RESU... [Published GlobeNewswire: Advertising News - May 28 2014]
Continuing progress in accelerating late stage ... [Published AstraZeneca - May 15 2014]
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