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Access Pharmaceuticals enters into exclusive license agreement with Norgine

Access Pharmaceuticals enters into exclusive license agreement with Norgine

ACCESS PHARMACEUTICALS, INC., an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe. [More]
BioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN treatment

BioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN treatment

BioDelivery Sciences International, Inc. announced today that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). [More]
Phase 3 ASPIRE clinical trial meets primary endpoint of progression-free survival

Phase 3 ASPIRE clinical trial meets primary endpoint of progression-free survival

Amgen and its subsidiary, Onyx Pharmaceuticals, Inc., today announced that a planned interim analysis demonstrated that the Phase 3 clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). [More]
Neuralstem doses final patient with NSI-566 stem cells in Phase II trial

Neuralstem doses final patient with NSI-566 stem cells in Phase II trial

Neuralstem, Inc. announced that the final patient was treated in its Phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). [More]
Clinical trial to look for genetic information in cancer patients

Clinical trial to look for genetic information in cancer patients

Sanford Health is working to enroll approximately 50 adult patients whose cancer has progressed after the first line of treatment or who have rare cancers without standard treatment options in a clinical trial to look for genetic information that could help customize treatment options. [More]
Regeneron announces FDA approval of EYLEA Injection for DME treatment

Regeneron announces FDA approval of EYLEA Injection for DME treatment

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). [More]
Naltrexone may be effective in diminishing ICD symptoms in PD patients, study finds

Naltrexone may be effective in diminishing ICD symptoms in PD patients, study finds

Up to 20 percent of Parkinson's disease (PD) patients and their families may confront a common but largely unrecognized challenge: the occurrence of impulse control disorders (ICDs) such as compulsive gambling, sexual behavior, eating, or spending. [More]
EMA CHMP issues positive opinion for label updates to Takeda's Vipidia, Vipdomet and Incresync

EMA CHMP issues positive opinion for label updates to Takeda's Vipidia, Vipdomet and Incresync

Takeda Pharmaceuticals International GmbH today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued positive opinions for updates to the Summary of Product Characteristics (SmPC) for Vipidia (alogliptin) and the fixed-dose combination (FDC) therapies Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone). [More]
CardioNova initiates Phase 1b clinical trial with AtheroNova's AHRO-001

CardioNova initiates Phase 1b clinical trial with AtheroNova's AHRO-001

AtheroNova Inc., a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces that its partner, CardioNova, has accomplished first dosing of subjects for its Phase 1b clinical trial with AtheroNova's lead compound, AHRO-001. [More]
EMD Serono begins MSB0010718C Phase II study in mMCC patients

EMD Serono begins MSB0010718C Phase II study in mMCC patients

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). [More]
New pill-only antiviral drug regimens could cure hardest-to-treat hepatitis C

New pill-only antiviral drug regimens could cure hardest-to-treat hepatitis C

Two new pill-only antiviral drug regimens could provide shorter, more effective treatment options with fewer side effects for the majority of patients infected with hepatitis C, even those most difficult to treat, according to the results of two studies published in The Lancet. [More]
Cardioxyl reports positive results from CXL-1427 Phase I trial for treatment of ADHF

Cardioxyl reports positive results from CXL-1427 Phase I trial for treatment of ADHF

Cardioxyl Pharmaceuticals, Inc. announced today the positive results of a clinical trial demonstrating that CXL-1427, a novel potential treatment for acute decompensated heart failure (ADHF), was well tolerated in healthy volunteers. [More]
FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

FDA clears Lorus' LOR-253 IND application for treatment of hematologic malignancies

Lorus Therapeutics Inc. today announced that the Food and Drug Administration completed its review and cleared the company's Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma. [More]
Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). [More]
New treatment fights respiratory syncytial virus in children

New treatment fights respiratory syncytial virus in children

Researchers at Le Bonheur Children's Hospital and the University of Tennessee Health Science Center announced results of a clinical trial of a new drug shown to safely reduce the viral load and clinical illness of healthy adult volunteers intranasally infected with respiratory syncytial virus (RSV). [More]
Kinex receives FDA approval to begin Phase I study of KX2-391 Ointment for actinic keratosis

Kinex receives FDA approval to begin Phase I study of KX2-391 Ointment for actinic keratosis

Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. [More]
Paracetamol fails to beat placebo at relieving back pain

Paracetamol fails to beat placebo at relieving back pain

Paracetamol is no more effective than placebo at relieving acute lower back pain, according to new clinical trial results. [More]
Researchers uncover how malaria parasite becomes resistant to fosmidomycin drug

Researchers uncover how malaria parasite becomes resistant to fosmidomycin drug

Researchers have uncovered a way the malaria parasite becomes resistant to an investigational drug. The discovery, at Washington University School of Medicine in St. Louis, also is relevant for other infectious diseases including bacterial infections and tuberculosis. [More]
Advaxis, MedImmune team up for immuno-oncology clinical trial

Advaxis, MedImmune team up for immuno-oncology clinical trial

Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca. [More]
Glide Pharma announces successful completion of pre-clinical proof-of-concept study with novel solid formulation of octreotide acetate

Glide Pharma announces successful completion of pre-clinical proof-of-concept study with novel solid formulation of octreotide acetate

Glide Pharma, the pharmaceutical development and device company focused on solid dose formulations of therapeutics and vaccines, today announced that its novel solid formulation of octreotide acetate achieved successful results in a pre-clinical proof-of-concept study comparing it with the currently marketed liquid product (Sandostatin®). [More]