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Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

Takeda Pharmaceutical Company Limited announced today that Takeda Global Research & Development Center, Inc. U.S., submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone for the treatment of hypertension, or high blood pressure.

24 Feb 2011

EpiCept 2010 fourth quarter net loss is $0.06 per share

EpiCept Corporation today announced operating and financial results for the fourth quarter and full year ended December 31, 2010, and provided an update on its key business initiatives.

24 Feb 2011

Oncolytics completes patient enrollment in REOLYSIN trial to treat metastatic colorectal cancer

Oncolytics Biotech Inc. announced today that enrollment has been completed in a U.K. translational clinical trial investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases.

23 Feb 2011

Trevena commences TRV120027 Phase 2a trial in patients with acute heart failure

Trevena Inc., the leader in G-protein coupled receptor biased ligand drug discovery, today announced the initiation of a Phase 2a clinical trial with its lead program, TRV120027, a beta-arrestin biased angiotensin II type 1 receptor ligand, the first biased ligand designed to treat patients with acute heart failure.

23 Feb 2011

Aestus commences ATx08-001 phase 2 trial to evaluate efficacy of novel pain therapeutic

Aestus Therapeutics, Inc., announced today that it has initiated screening of patients for a clinical trial to evaluate the efficacy of its novel pain therapeutic, ATx08-001. This placebo-controlled, two-dose level study will test the efficacy of ATx08-001 in reducing the pain following an outbreak of shingles.

23 Feb 2011

Diabetes technology granted patent in Australia

Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) a global company pioneering the development of a cell implant therapy to treat diabetes and neurodegenerative diseases, has been granted a patent by the Australian Patent Office for IMMUPEL(tm), LCT's industry-leading technology for encapsulating living cells prior to transplantation.

23 Feb 2011

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

A strategy developed by Massachusetts General Hospital (MGH) researchers to shield the ovaries of female mammals from the damaging effects of radiation and chemotherapy has passed an important milestone. A collaborative study with investigators from Oregon Health and Sciences University (OHSU), published online in the journal Fertility and Sterility, reports that brief preexposure of the ovaries to an FDA-approved agent called FTY720 preserved the fertility of female rhesus monkeys exposed to potentially lethal doses of radiation.

23 Feb 2011

Focused Ultrasound Surgery Foundation releases men's heath update on prostate cancer, BPH treatments

The Focused Ultrasound Surgery Foundation has released a special men's heath update in its February 2011 online newsletter.

23 Feb 2011

Tifacogin administration shows no treatment benefit in patients with severe CAP

Use of the blood clot-inhibiting medication tifacogin does not appear to improve outcomes of patients with severe community-acquired pneumonia, according to a study conducted by researchers from North and South America, Europe, Asia and Africa. The drug had shown some potential benefit in the sCAP subgroup of an earlier trial involving sepsis patients.

23 Feb 2011

Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

Infinity Pharmaceuticals, Inc. today announced the initiation of the randomized Phase 2 portion of the trial of IPI-926 in combination with gemcitabine in patients with previously untreated, metastatic, pancreatic cancer.

22 Feb 2011

KemPharm commences KP201 Phase 1 trial for pain

KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline.

22 Feb 2011

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Pieris AG announced today the upcoming presentation of new preclinical and interim Phase I clinical trial data for its PRS-050 Anticalin(r) program, currently under evaluation for the treatment of cancer.

22 Feb 2011

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

Fate Therapeutics, Inc. presented encouraging preliminary data from an ongoing Phase 1b clinical trial of FT1050 at the 2011 BMT Tandem Meetings in Honolulu, Hawaii.

22 Feb 2011

New study: Rapamycin reverses cardiac muscle damage in LEOPARD syndrome mouse model

Congenital heart diseases affect approximately one in 100 patients, making them the most common type of birth defect and the number-one cause of pediatric deaths.

21 Feb 2011

Investigational heart valve implanted in patient through small puncture hole in leg

Physicians at the Methodist DeBakey Heart & Vascular Center in Houston implanted a new investigational heart valve in a patient through a small puncture hole in the leg.

21 Feb 2011

Lifestyle therapy program may help manage cardiovascular risk factors

Two/thirds of adults with high cholesterol and half with high blood pressure are not being treated effectively for these conditions, according to a recent announcement by the Centers for Disease Control and Prevention (CDC). This disturbing data spotlights the crucial need for new solutions to reduce the risk factors that are behind the current epidemic of chronic illness in the U.S.

21 Feb 2011

Bangladesh cholera vaccine trial

Bangladesh will conduct the world’s largest clinical trial of an affordable cholera vaccine which could save tens of thousands of lives. The study began Thursday and involves nearly 250,000 people near the capital, Dhaka.

20 Feb 2011

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Protalix BioTherapeutics, Inc., announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada.

19 Feb 2011

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation today announced three-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate. Sustained or further improvements were observed across all endpoints, including bone disease, at the three-year timepoint.

19 Feb 2011

FDA recognizes safety and efficacy of True Results LAP-BAND device

The True Results team of gastric band surgeons and medical weight loss experts is pleased the U.S. Food and Drug Administration has recognized the long-standing safety and effectiveness record of the LAP-BAND System.

19 Feb 2011

Clinical Trial News and Research

Takeda submits NDA to FDA for fixed-dose combination of azilsartan medoxomil plus CLD to treat hypertension

EpiCept 2010 fourth quarter net loss is $0.06 per share

Oncolytics completes patient enrollment in REOLYSIN trial to treat metastatic colorectal cancer

Trevena commences TRV120027 Phase 2a trial in patients with acute heart failure

Aestus commences ATx08-001 phase 2 trial to evaluate efficacy of novel pain therapeutic

Diabetes technology granted patent in Australia

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

Focused Ultrasound Surgery Foundation releases men's heath update on prostate cancer, BPH treatments

Tifacogin administration shows no treatment benefit in patients with severe CAP

Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer

KemPharm commences KP201 Phase 1 trial for pain

Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California

Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions

New study: Rapamycin reverses cardiac muscle damage in LEOPARD syndrome mouse model

Investigational heart valve implanted in patient through small puncture hole in leg

Lifestyle therapy program may help manage cardiovascular risk factors

Bangladesh cholera vaccine trial

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease

FDA recognizes safety and efficacy of True Results LAP-BAND device

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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