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FDA grants Fast Track designation to Juventas' JVS-100 drug candidate and allows Phase 2b clinical trial

Juventas Therapeutics, Inc., a clinical-stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body, today announced that its product candidate, JVS-100, received Fast Track designation from the U.S. Food and Drug Administration for the treatment of advanced ischemic chronic heart failure.

16 Jun 2015

Apexigen initiates APX005M Phase 1 clinical trial in adults with solid tumors

Apexigen, Inc., a biopharmaceutical company discovering and developing innovative antibody drugs for the treatment of cancer and other life-threatening diseases, announced today the initiation of a Phase 1 clinical trial of APX005M, the company's lead proprietary anticancer program.

16 Jun 2015

OncoSec enrolls first patient in Phase II trial of ImmunoPulse IL-12 for treatment of HNSCC

OncoSec Medical Inc., a company developing DNA-based intratumoral cancer immunotherapies, announced today that the company has enrolled the first patient into OMS-I130, a Phase II clinical trial of ImmunoPulse IL-12 in patients with treatment-refractory, metastatic and unresectable squamous cell carcinoma of the head and neck (HNSCC).

16 Jun 2015

Novartis presents positive Phase III results of Farydak therapy at EHA

Novartis today presented results from a pivotal Phase III clinical trial exploratory subgroup analysis showing a 7.8-month improvement in median progression-free survival when using Farydak in combination with bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma who had received two or more prior regimens, including bortezomib and an immunomodulatory agent.

16 Jun 2015

Laurent reports positive topline results from LAU-7b Phase 1b trial in adult CF patients

Laurent Pharmaceuticals Inc. announced today positive topline results from a Phase 1b clinical trial with LAU-7b in adult CF patients. LAU-7b is a novel oral formulation of fenretinide, a synthetic retinoid investigated for its lipid modulating properties and potential to address the aberrant inflammatory response in CF.

15 Jun 2015

Juniper announces enrollment of first patient in COL-1077 Phase II trial to reduce pain during endometrial biopsy

Juniper Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development of therapeutics for women's health, announced today the first patient has been enrolled in a Phase II clinical trial of COL-1077, a 10% lidocaine bioadhesive gel that is intended as an acute-use anesthetic during minimally invasive gynecologic procedures.

15 Jun 2015

Clinical studies confirm safety, efficacy of opicapone in Parkinson’s disease patients

BIAL is presenting 11 research posters at the 19th International Congress of Parkinson's Disease and Movement Disorders (June 14–15, San Diego, CA). These evaluate the safety and efficacy of opicapone (BIA 9-1067), a novel once-daily catechol-O-methyltransferase (COMT) inhibitor for use as adjunctive therapy in levodopa-treated Parkinson’s disease patients with end of dose motor fluctuations.

15 Jun 2015

Combination of tosedostat and LDAC results in overall response rate of 54% in elderly patients with AML

CTI BioPharma Corp. today announced findings from an investigator-sponsored Phase 2 trial in patients with either primary (de novo) acute myeloid leukemia (AML) or AML that has evolved from myelodysplastic syndrome (MDS). Results showed the combination of tosedostat with low dose cytarabine/Ara-C (LDAC) resulted in an overall response rate (ORR) of 54 percent in elderly patients with AML – with 45 percent of patients achieving durable complete responses (CR).

15 Jun 2015

Study shows that TNFi dose reduction strategy can help in optimal management of RA

The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2015) showed that, in rheumatoid arthritis (RA) patients, a good clinical response to maintenance treatment with a tumour necrosis factor inhibitor (TNFi) was maintained even when the dose was reduced by one-third.

15 Jun 2015

Hydroxychloroquine drug fails to reduce mild-moderate pain from primary hand osteoarthritis

The results of an interventional trial presented today at the European League Against Rheumatism Annual Congress (EULAR 2015) showed that use of the disease-modifying anti-rheumatic drug hydroxychloroquine for 24 weeks did not diminish mild-moderate pain from primary hand osteoarthritis (OA).

14 Jun 2015

NCCN ORP receives $2-million grant from Boehringer Ingelheim to facilitate studies of afatinib in NSCLC

The National Comprehensive Cancer Network Oncology Research Program (ORP) has been awarded a $2-million grant from Boehringer Ingelheim Pharmaceuticals, Inc. to develop a program to evaluate scientifically targeted combination approaches with afatinib in the treatment of non-small cell lung cancer (NSCLC).

12 Jun 2015

Tioga Pharmaceuticals announces commencement of asimadoline Phase 2 study for treatment of pruritus

Tioga Pharmaceuticals, a clinical stage biotechnology company, today announced the initiation of a Phase 2 clinical study of asimadoline, a novel, well-studied kappa-opioid receptor specific agonist, for the treatment of pruritus or itching. The double-blind, placebo-controlled clinical study is designed to evaluate the safety, tolerability, and clinical efficacy of asimadoline in patients with pruritus due to atopic dermatitis and is being conducted at 20 clinical study centers in the United States.

11 Jun 2015

Isis Pharmaceuticals provides update on ISIS-SMN Rx Phase 2 clinical study in infants with Type I SMA

Isis Pharmaceuticals, Inc. today provided an update on its ongoing open-label Phase 2 clinical study of ISIS-SMN Rx in infants with Type I spinal muscular atrophy (SMA).

11 Jun 2015

SQUIRE phase III study shows necitumumab improves median overall survival in squamous NSCLC patients

This week, Lancet Oncology reports results of a 1,093-person phase III clinical trial of the drug necitumumab (IMC-11F8) combined with chemotherapies gemcitabine and cisplatin against stage IV squamous non-small cell lung cancer. With addition of necitumumab, median overall survival was 11.5 months compared with median survival of 9.9 months with the two chemotherapies alone.

11 Jun 2015

Ixekizumab drug shows quick and extensive improvements in patients with psoriasis

A University of Manchester led trial of a new psoriasis drug has resulted in 40 percent of people showing a complete clearance of psoriatic plaques after 12 weeks of treatment and over 90 percent showing improvement.

11 Jun 2015

Research progress with promising Alzheimer's drug Xanamem

Actinogen Limited (Actinogen Medical, ASX: ACW), an Australian biotechnology company focused on the development of novel treatments for Alzheimer’s disease and other major age-related neurodegenerative disorders, is pleased to announce that it has received ethics approval to initiate the third and final stage of the second Phase I trial of its lead Alzheimer’s drug candidate, Xanamem™.

11 Jun 2015

UC San Diego researchers launch clinical trial to evaluate safety, efficacy of suramin drug for autism

Researchers at the University of California, San Diego School of Medicine have launched a clinical trial to investigate the safety and efficacy of an unprecedented drug therapy for autism.

11 Jun 2015

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

Amgen today announced that the Company will discuss the data supporting the Repatha (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

10 Jun 2015

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis.

10 Jun 2015

FDA agrees to Oncogenex' proposed amendment to Phase 3 AFFINITY protocol

OncoGenex Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed amendment to the Phase 3 AFFINITY protocol and statistical analysis plan.

10 Jun 2015

Drug Trial News

FDA grants Fast Track designation to Juventas' JVS-100 drug candidate and allows Phase 2b clinical trial

Apexigen initiates APX005M Phase 1 clinical trial in adults with solid tumors

OncoSec enrolls first patient in Phase II trial of ImmunoPulse IL-12 for treatment of HNSCC

Novartis presents positive Phase III results of Farydak therapy at EHA

Laurent reports positive topline results from LAU-7b Phase 1b trial in adult CF patients

Juniper announces enrollment of first patient in COL-1077 Phase II trial to reduce pain during endometrial biopsy

Clinical studies confirm safety, efficacy of opicapone in Parkinson’s disease patients

Combination of tosedostat and LDAC results in overall response rate of 54% in elderly patients with AML

Study shows that TNFi dose reduction strategy can help in optimal management of RA

Hydroxychloroquine drug fails to reduce mild-moderate pain from primary hand osteoarthritis

NCCN ORP receives $2-million grant from Boehringer Ingelheim to facilitate studies of afatinib in NSCLC

Tioga Pharmaceuticals announces commencement of asimadoline Phase 2 study for treatment of pruritus

Isis Pharmaceuticals provides update on ISIS-SMN Rx Phase 2 clinical study in infants with Type I SMA

SQUIRE phase III study shows necitumumab improves median overall survival in squamous NSCLC patients

Ixekizumab drug shows quick and extensive improvements in patients with psoriasis

Research progress with promising Alzheimer's drug Xanamem

UC San Diego researchers launch clinical trial to evaluate safety, efficacy of suramin drug for autism

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

LEO Pharma reports encouraging data from PSO-FAST clinical trial of Enstilar for psoriasis treatment

FDA agrees to Oncogenex' proposed amendment to Phase 3 AFFINITY protocol

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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