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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 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]
CFDA approves CASI's ENMD-2076 Phase II trial in triple-negative breast cancer patients

CFDA approves CASI's ENMD-2076 Phase II trial in triple-negative breast cancer patients

CASI Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that China's Food and Drug Administration has approved the Company's application to conduct a Phase II clinical trial in triple-negative breast cancer (TNBC) patients in China for its proprietary drug candidate, ENMD-2076. [More]
Scientist uses samples of beating heart tissue to test effect of drugs

Scientist uses samples of beating heart tissue to test effect of drugs

A Coventry University scientist has developed a pioneering new way - using samples of beating heart tissue - to test the effect of drugs on the heart without using human or animal trials. [More]
Combination drug therapy cures chronic hepatitis C in co-infected HIV patients

Combination drug therapy cures chronic hepatitis C in co-infected HIV patients

A multicenter team of researchers report that in a phase III clinical trial, a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C. [More]
Phase 3 VIVID-DME trial of EYLEA Injection for treatment of DME shows improvement in visual acuity

Phase 3 VIVID-DME trial of EYLEA Injection for treatment of DME shows improvement in visual acuity

Regeneron Pharmaceuticals, Inc. today announced that in the Phase 3 VIVID-DME trial of EYLEA® (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) and EYLEA 2 mg dosed every two months (after 5 initial monthly injections, 2Q8) showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100 (2 years), compared to laser photocoagulation. [More]
Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

Ipsen’s Somatuline CLARINET Phase III study published online in NEJM

The U.S. affiliate of Ipsen today announced that the New England Journal of Medicine has published clinical trial results showing that Somatuline Autogel / Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) achieved statistically significant prolongation of progression free survival (PFS) over placebo in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). [More]