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EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

QLT Inc. today announced that QLT091001, an oral synthetic retinoid, has received positive opinions for two distinct Orphan Drug Designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for the treatment of the inherited retinal degenerative diseases, Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP).

10 Feb 2011

Vical 2010 net loss increases to $30.4 million

Vical Incorporated today reported financial results for the year ended December 31, 2010. Vical had cash and investments of approximately $61 million at year-end 2010. The company received approximately $37 million of net proceeds from the sale of equity securities during 2010.

10 Feb 2011

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Diamyd Medical´s US Phase II clinical trial, evaluating the ability of the candidate drug NP2 Enkephalin to reduce cancer pain, is posted on the ClinicalTrials.gov website.

10 Feb 2011

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

In a study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting -, in San Francisco, researchers will present findings that show that the use of the hormone 17-Hydroxyprogesterone does not reduce the rate of preterm delivery or neonatal complications in twins.

10 Feb 2011

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Teva Pharmaceutical Industries Ltd. today announced results from a Phase III study of QNAZE™ (beclomethasone dipropionate [BDP]) HFA, its nasal aerosol corticosteroid in development for the treatment of perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR).

10 Feb 2011

Everolimus phase III study shows improved progression-free survival in patients with pNET

In an international Phase III randomized study, everolimus, an inhibitor of the mammalian target of rapamycin, has shown to dramatically improve progression-free survival for patients with advanced pancreatic neuroendocrine tumors, according to researchers from The University of Texas MD Anderson Cancer Center.

9 Feb 2011

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced the initiation of separate Phase 2 clinical studies of its product candidate TC-6987 in disorders characterized by inflammation, one in asthma and one in Type 2 diabetes.

9 Feb 2011

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has initiated a Phase 2 clinical trial, following conclusion of a review by the United States Food and Drug Administration (FDA) of a protocol submitted by PolyMedix, to assess the safety and efficacy of its heptagonist, PMX-60056, in reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures.

9 Feb 2011

GeoVax opens second HIV clinical trial site at Alabama Vaccine Research Clinic

GeoVax Labs, Inc., a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today the opening of a second clinical trial site at the Alabama Vaccine Research Clinic (AVRC) of the University of Alabama at Birmingham (UAB) to expand the company's HIV therapeutic vaccine trial.

9 Feb 2011

CeNeRx announces FDA approval of CXB909 IND for neuroprotection and neurodegenerative disorders

CeNeRx BioPharma, Inc., a clinical-stage company developing and commercializing innovative treatments for diseases of the central nervous system (CNS), today announced FDA approval of its IND and reported the first clinical results in humans for CXB909, a novel agent that has demonstrated utility in preclinical models of neuroprotection and neurodegenerative disorders.

9 Feb 2011

A.P. Pharma provides update on response to APF530 Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today provided an update on its progress toward responding to the Complete Response Letter for APF530 that the Company received from the U.S. Food and Drug Administration (FDA) in March 2010.

9 Feb 2011

R-Tech commences RK-023 Phase I study for treatment of eyelash hypotrichosis

R-Tech Ueno is pleased to announce the initiation of a Phase I clinical study of RK-023, a new compound that is being developed for the treatment of hypotrichosis of the eyelashes.

9 Feb 2011

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

Gentium S.p.A. today announced that ongoing preclinical and clinical studies on Defibrotide have been completed and confirmed its plan to file for regulatory approval of Defibrotide with the US Food and Drug Administration and the European Medicines Agency by the end of the second quarter of 2011.

9 Feb 2011

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced it has received Food and Drug Administration ("FDA") clearance for its phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States.

9 Feb 2011

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

Pervasis Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status for Vascugel® for the prevention of hemodialysis access failure in patients with end stage renal disease (ESRD).

9 Feb 2011

CytRx's bafetinib helps reduce skeletal complications in cancer patients

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that results from a series of preclinical studies show that bafetinib may be useful in preventing bone loss in cancer patients who are at high risk for this event.

8 Feb 2011

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

Rib-X Pharmaceuticals, an antibiotics company with a broad development-stage pipeline, today announced the initiation of a Phase 2b clinical trial to evaluate delafloxacin, linezolid and vancomycin for the treatment of acute bacterial skin and skin structure infections, including infections caused by methicillin-resistant Staphylococcus aureus.

8 Feb 2011

Scientists develop low cost, nanometer-sized drug to treat chronic wounds

A low cost, nanometer-sized drug to treat chronic wounds, such as diabetic foot ulcers or burns, has been developed by a group of scientists from the Hebrew University of Jerusalem, Harvard Medical School and others in the U.S. and Japan.

8 Feb 2011

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group, announced today that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

8 Feb 2011

Drug Trial News

EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness

Vical 2010 net loss increases to $30.4 million

Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov

Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study

Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial

Everolimus phase III study shows improved progression-free survival in patients with pNET

Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes

PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI

GeoVax opens second HIV clinical trial site at Alabama Vaccine Research Clinic

CeNeRx announces FDA approval of CXB909 IND for neuroprotection and neurodegenerative disorders

A.P. Pharma provides update on response to APF530 Complete Response Letter

R-Tech commences RK-023 Phase I study for treatment of eyelash hypotrichosis

Gentium completes Defibrotide clinical studies, plans to file for regulatory approval

Medicago granted FDA clearance for clinical development of seasonal flu vaccine

Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients

CytRx's bafetinib helps reduce skeletal complications in cancer patients

Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI

Scientists develop low cost, nanometer-sized drug to treat chronic wounds

Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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