primary endpoint

Type: Keyphrase
Name: primary endpoint
First reported 16 hours ago - Updated 3 hours ago - 1 reports

NICE clears path for patient access to lenalidomide for rare form of blood cancer

Celgene has announced that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) on its oral blood cancer treatment, lenalidomide (Revlimid®) for transfusion-dependent anaemia due to low- or intermediate-1-risk ... [Published Ecancer Medicalscience - 16 hours ago]
First reported Aug 27 2014 - Updated 13 hours ago - 1 reports

Medtronic begins large scale CRT trial

News EditorMedtronic (MDT) commences a 3,000-patient 200-site post market clinical trial to assess the superiority of cardiac resynchronization therapy (CRT) devices utilizing the AdaptivCRT feature versus standard CRT in heart failure patients. AdaptivCRT ... [Published Seeking Alpha - Aug 27 2014]
First reported 15 hours ago - Updated 15 hours ago - 1 reports

Baxter's Phase III hemophilia A trial meets primary endpoint

(MarketLine via COMTEX News Network) -- Baxter International Inc., a developer of new products for hemophilia and immune disorders, has announced that its Phase III pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant ... [Published PredictWallStreet - 15 hours ago]
First reported Aug 27 2014 - Updated Aug 27 2014 - 1 reports

DEFINITIVE LE published: Directional atherectomy effective regardless of diabetes status

Patients with or without diabetes who underwent directional atherectomy for peripheral artery disease experienced similar rates of primary patency at 12 months, according to findings from the DEFINITIVE LE trial.The results, which were initially presented ... [Published Orthopedics Today - Aug 27 2014]
First reported Aug 27 2014 - Updated Aug 27 2014 - 1 reports

NWBO Reports Second Quarter Financials

By Grant Zeng, CFANASDAQ:NWBOThere was no revenue for the second quarter of 2014 ( NWBO ).Research and development expense was $21.5 million for the three months ended June 30, 2014 compared to $8.4 million for the three months ended June 30, 2013. The ... [Published Yahoo! Finance - Aug 27 2014]
Entities: Tumor, Phase III, Phase I/II
First reported Aug 27 2014 - Updated Aug 27 2014 - 1 reports

Predicting PARADIGM-HF, Or What To Expect When You're Expecting

The wait is almost over. For the last 5 months the most eagerly awaited trial in the cardiovascular universe has been PARADIGM-HF, the large (8,500 patient) trial of a new and novel heart failure drug from Novartis. If reality lives up to the early hope ... [Published Forbes.com - Aug 27 2014]
First reported Aug 27 2014 - Updated Aug 27 2014 - 1 reports

RedHill to pursue broader label for H. pylori drug

News EditorBased on discussions with the FDA , RedHill Biopharma (NASDAQ:RDHL) will pursue labeling for its H. pylori drug candidate, RHB-105, as a first-line treatment of H. pylori infection regardless of ulcer status. Current treatments are indicated ... [Published Seeking Alpha - Aug 27 2014]
First reported Aug 26 2014 - Updated Aug 26 2014 - 1 reports

Onyx's Phase III multiple myeloma trial fails to meet primary endpoint

Amgen, Inc., a biotechnology company, and its subsidiary, Onyx Pharmaceuticals, Inc., have announced that the Phase III clinical trial, FOCUS, did not meet its primary endpoint of improving overall survival, or OS, in patients with multiple myeloma. The ... [Published Individual.com - Aug 26 2014]
First reported Aug 25 2014 - Updated Aug 25 2014 - 2 reports

Kindred study of canine pain drug misses endpoint

San Francisco-based Kindred Bioscience ($KIN) did not meet the primary endpoint during a trial of CereKin, its drug for canine osteoarthritis, based off studies for Amgen ($AMGN) and Pfizer's ($PFE) Enbrel. The study was randomized, double-blind and placebo-controlled ... [Published Fierce Biotech IT - Aug 25 2014]
First reported Aug 25 2014 - Updated Aug 25 2014 - 1 reports

First patient enrolled in La Jolla HRS trial

12:52 ET | About: La Jolla Pharmaceutical Co. (LJPC)La Jolla Pharmaceuticals (LJPC +2%) reports the first patient enrollment in its Phase 1/2 clinical trial of LJPC-501 for the treatment of types 1 and 2 hepatorenal syndrome (HRS). The primary endpoint ... [Published Seeking Alpha - Aug 25 2014]
First reported Aug 25 2014 - Updated Aug 25 2014 - 1 reports

Eisai's Phase III lung cancer study fails to meet primary endpoint

Eisai Co., Ltd., a Japanese pharmaceutical company, has announced that the Phase III study, or Study 302, with its in-house developed anticancer agent, eribulin mesylate, in patients with advanced non-small cell lung cancer, or NSCLC, fails to meet primary ... [Published Individual.com - Aug 25 2014]
First reported Aug 25 2014 - Updated Aug 25 2014 - 1 reports

Northwest receives approvals for enhancement of Phase III brain cancer trial

(MarketLine via COMTEX News Network) -- Northwest Biotherapeutics, or NW Bio, a biotechnology company, has received regulatory approvals to make enhancements to its ongoing Phase III clinical trial for DCVax-L Glioblastoma multiforme, or GBM, brain c ... [Published PredictWallStreet - Aug 25 2014]

Quotes

...in patients with a wide range of incoming triglycerides, including FCS patients," said Richard Geary, senior vice president of development at Isis. "Our broad experience developing drugs to treat lipid disorders, including the good working relationships we have established with the physicians and centers that treat many FCS patients should support the rapid advancement of this program. We currently plan to advance ISIS-APOCIII Rx  without seeking a partner."
Dr Patrik De Haes, ThromboGenics CEO, said: "We have adapted our organizational structure so that we are in position to achieve profitability in the US in 2016, based on sales of JETREA of around €30 million and to become overall cash flow positive"
...and expand treatment options for patients with hemophilia," said John Orloff, M D , vice president and global head of R&D for Baxter BioScience. "We look forward to advancing the BAX 855 program to US regulatory submission by the end of this year."
"We are very pleased by these results, which support the potential of ceftazidime-avibactam as a new treatment option for patients with these serious and life-threatening intra-abdominal infections" said David Nicholson,PhD, Senior vice president, Actavis Global Brands R&D

More Content

All (1173) | News (975) | Reports (0) | Blogs (170) | Audio/Video (0) | Fact Sheets (1) | Press Releases (16)
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RedHill Expands ERADICATE Study on RHB-105 for ... [Published Nasdaq - 3 hours ago]
Meropenem administration results in a better cl... [Published IVTEAM - 4 hours ago]
RedHill Expands ERADICATE Study on RHB-105 for ... [Published Zacks.com - 5 hours ago]
Isis Initiates Phase 3 Study of FCS Drug [Published Drug Discovery and Development - 6 hours ago]
MediciNova Rises on FDA's Nod on MN-166 Study I... [Published Zacks.com - 7 hours ago]
Ablynx's (ABLYF) CEO Edwin Moses on Q2 2014 Res... [Published Seeking Alpha - 8 hours ago]
Sipuleucel-T Helps ADT Boost Prostate Cancer Im... [Published OncLive - 8 hours ago]
Treatment of Perianal Fistulizing Crohn Disease [Published General Medicine eJournal - 11 hours ago]
ThromboGenics Business Update H1 2014 [Published RCL Advisors - 11 hours ago]
Spectrum Pharmaceuticals: A Long-Term Bet [Published Seeking Alpha - 13 hours ago]
OncoPep Raises $6.9 Million Series B Financing ... [Published EON: Enhanced Online News - 15 hours ago]
Baxter's Phase III hemophilia A trial meets pri... [Published PredictWallStreet - 15 hours ago]
NICE clears path for patient access to lenalido... [Published Ecancer Medicalscience - 16 hours ago]
Isis Pharmaceuticals Initiates Phase 3 Study of... [Published Nasdaq - 16 hours ago]
Actinium to Present at the Rodman & Renshaw Ann... [Published BioPortfolio - 16 hours ago]
QRxPharma: ASX Preliminary Final Report – 2014 ... [Published Stock Nod - 18 hours ago]
Actavis announces positive results from Phase I... [Published Individual.com - 19 hours ago]
AstraZeneca announces positive results from Pha... [Published Individual.com - 21 hours ago]
Findings from F. Yuan and Co-Researchers Provid... [Published HispanicBusiness.com - Aug 28 2014]
Actavis Announces Positive Topline Results From... [Published 4 Traders - Aug 28 2014]
The Opportunity Is Now For Kindred Biosciences [Published Seeking Alpha - Aug 28 2014]
Promacta (Eltrombopag) Gets Additional Indication [Published PT Community - Aug 27 2014]
Studies from Novartis Animal Health Have Provid... [Published 4 Traders - Aug 27 2014]
DEFINITIVE LE published: Directional atherectom... [Published Orthopedics Today - Aug 27 2014]
Alexion Launches Eculizumab Trial In Kidney Tra... [Published Bioresearch Online - Aug 27 2014]
TKA provides excellent outcomes after lower-ext... [Published Orthopedics Today - Aug 27 2014]
NWBO Reports Second Quarter Financials [Published Yahoo! Finance - Aug 27 2014]
Update: BioSpecifics Announces Positive XIAFLEX... [Published BioPortfolio - Aug 27 2014]
FDA Approves New Blood Disorder Treatment [Published Pharmacy Times - Aug 27 2014]
Update: BioSpecifics Announces Positive XIAFLEX... [Published Seeking Alpha - Aug 27 2014]
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Blogs

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Baxter reports positive top-line results from P... [Published PBR - News - Aug 25 2014]
Nektar Therapeutics reports Baxter International has announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic ...
Frontrunning: August 21 [Published Zero Hedge - Aug 21 2014]
FTW: Europe Stocks Rise as Data Signals Need for Stimulus ( BBG ) More de-escalation: Dozens die in Ukraine in street battles, Donetsk shelling ( Reuters ) Calm largely holds in Missouri after grand jury opens shooting investigation ( Reuters ) Attorney ...
BioNews [8.18.14] [Published eClinical Trends - Aug 18 2014]
Top News HeadlineCompanyType Pfizer Announces Submission of Palbociclib New Drug Application to the FDA PfizerNDA for palbociclib Novo Nordisk accepts a $90K slap on the hand for delaying news of Tresiba setback Novo NordiskAccepts fine ...
BioNews [8.15.14] [Published eClinical Trends - Aug 15 2014]
Top News HeadlineCompanyType Gilead fends off Roche as hep C heavyweights fight for blockbuster rights GileadHep C Drug Chikungunya vaccine shows antibody response in Phase I trial NIAIDPositive results CF biotech ProQR shoots for a ...
Coherus' CHS-1420 meets primary endpoint in piv... [Published PBR - News - Aug 15 2014]
Coherus BioSciences has announced that CHS-1420, its proposed biosimilar of adalimumab (Humira), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira in healthy subjects. ...
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Press Releases

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NeuroSearch appeals Copenhagen City Court judgm... [Published GlobeNewswire: Acquisitions News - Aug 18 2014]
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]
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