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Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy.

9 Feb 2010

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

An early stage clinical trial of the experimental drug dimebon (latrepirdine) in people with Huntington's disease appears to be safe and may improve cognition. That is the conclusion of a study published today in the Archives of Neurology.

9 Feb 2010

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.

9 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

Sorin Group announces first implant of FDA approved Paradym CRT Model 8750 defibrillator

Sorin Group, a global leader in the treatment of cardiovascular disease, announced today U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym™ CRT Model 8750. Featuring a new, state-of-the-art battery technology, Paradym™ CRT delivers 37 Joules, the highest energy of any implantable cardiac defibrillator (ICD) currently available.

6 Feb 2010

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

Centerphase has entered into a collaboration with Mayo Clinic to speed the introduction of new medical treatments developed by the biopharmaceutical industry. The Company addressed the root causes historically plaguing the clinical trials process: the lack of a systematic, structured approach for evaluating and optimizing protocols and the tremendous burdens associated with trial start-up administration.

5 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

World Heart Corporation ("WorldHeart") announced today that it was part of a consortium awarded a $5.6 million, 4-year contract by the National Institutes of Health (NIH) to further develop the PediaFlow™ VAD to clinical trial readiness.

5 Feb 2010

NHLBI awarded four contracts to test new devices to help children with congenital heart defects

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has awarded four contracts totaling $23.6 million to begin preclinical testing of devices to help children born with congenital heart defects or those who develop heart failure.

5 Feb 2010

BioClinica signs three-year, multi-million dollar deal with Cephalon

BioClinica, Inc., a leading global provider of clinical trial services, has signed a three-year, multi-million dollar deal with Cephalon, Inc. for clinical trial technology and support services.

From Clario 5 Feb 2010

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

Bioheart, Inc., announced today that the company has commenced work on its REGEN trial, a Phase I Clinical Trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). Bioheart’s MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells,that are grown from a patient’s own muscle. MyoCell® has been tested successfully on patients in four clinical trials.

5 Feb 2010

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida.

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Isotechnika Pharma Inc. today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM).

4 Feb 2010

Phase Forward to participate in DIA Workshop and Clinical Trial Supply event

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, will participate in two industry events this month: The 13th Annual DIA Workshop in Japan for Clinical Data Management (Booths 4 and 5) and VIB Pharma’s 11th Annual Clinical Trial Supply (Booth 3).

4 Feb 2010

Results from three phase two studies show the effectiveness of Tanezumab

Tanezumab, a humanized monoclonal antibody that targets nerve-growth factor, reduced pain in three common pain conditions, according to the results from three phase two studies presented today in a single poster at the American Academy of Pain Medicine's 26th Annual Meeting.

4 Feb 2010

Transplantation of pulmonary progenitor cells derived from hESCs promising for acute lung injury

Stem cell researchers exploring a new approach for the care of respiratory diseases report that an experimental treatment involving transplantable lung cells was associated with improved outcomes in tests on mice with acute lung injury. The lung cells were derived from human embryonic stem cells (hESCs). Findings by investigators at The University of Texas Health Science Center at Houston are scheduled to appear in the March issue of Molecular Therapy.

4 Feb 2010

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Seattle Genetics, Inc. and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma.

4 Feb 2010

UBC announces the opening of new global office in Tokyo, Japan

nited BioSource Corporation (UBC) today announced the opening of its newest global office in Tokyo, Japan. The UBC office will be led by Kumpei Kobayashi, PharmD, a biopharmaceutical industry veteran with over 20 years of product development experience throughout the Asia-Pacific region.

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

Clinical Trial News and Research

Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

AMRI announces fourth-quarter and full-year 2009 results

Sorin Group announces first implant of FDA approved Paradym CRT Model 8750 defibrillator

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

NHLBI awarded four contracts to test new devices to help children with congenital heart defects

BioClinica signs three-year, multi-million dollar deal with Cephalon

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Phase Forward to participate in DIA Workshop and Clinical Trial Supply event

Results from three phase two studies show the effectiveness of Tanezumab

Transplantation of pulmonary progenitor cells derived from hESCs promising for acute lung injury

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

UBC announces the opening of new global office in Tokyo, Japan

Phase 2a clinical trial results of VX-809 in patients with CF announced

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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