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Combination therapy can reduce recurrence of small, HER2-positive breast tumors

In a phase 2 clinical trial, women with small (stage 1), HER2-positive breast tumors who received a combination of lower-intensity chemotherapy and a targeted drug following surgery were highly unlikely to have the cancer recur within three years of treatment, investigators at Dana-Farber Cancer Institute and other institutions report in a paper published today by the New England Journal of Medicine.

8 Jan 2015

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100.

7 Jan 2015

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.

6 Jan 2015

Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

Johnson & Johnson today announced the start of a Phase 1, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies.

6 Jan 2015

LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis.

6 Jan 2015

BrainStorm's phase 2a ALS study meets primary endpoint

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced positive final results from its phase 2a clinical trial of NurOwn™ in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem.

6 Jan 2015

FDA receives Actavis' NDA resubmission for cariprazine

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.

6 Jan 2015

Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Aeterna Zentaris Inc. today announced that an article on final data for the Phase 1 portion of the ongoing Phase 1/2 trial in prostate cancer with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin, has been published in the December issue of Clinical Cancer Research.

31 Dec 2014

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

31 Dec 2014

Can-Fite BioPharma completes RA Phase III study of lead drug candidate CF101

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it completed the design of the Rheumatoid Arthritis (RA) Phase III study of its lead drug candidate CF101.

31 Dec 2014

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. announced that its strategic partner, G-treeBNT Co. Ltd., has filed an IND with the Korean Ministry of Food and Drug Safety for a Phase IIB/III clinical trial with RGN-259 (designated GBT-201 in Korea and the licensed Pan Asia territory) for the treatment of patients with dry eye syndrome.

29 Dec 2014

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, today announced that it has started its bremelanotide pivotal registration program.

29 Dec 2014

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Kinex Pharmaceuticals announced today that the first patient has been dosed with KX2-361 at Roswell Park Cancer Institute.

25 Dec 2014

Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

Actavis plc today confirmed that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for the fixed-dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.

25 Dec 2014

PTC begins rolling NDA submission for Translarna to treat nmDMD

PTC Therapeutics, Inc. today announced that it has commenced a rolling submission of a New Drug Application to the United States Food and Drug Administration for Translarna™ for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

23 Dec 2014

Mirati begins dosage in MGCD265 Phase 1b clinical trial for NSCLC

Mirati Therapeutics, Inc. today announced that the first patient with Non-Small Cell Lung Cancer (NSCLC) has been dosed in a Phase 1b clinical trial of MGCD265 in selected patients exhibiting genetic alterations of MET or Axl.

23 Dec 2014

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare disorders, today announced validation by the European Medicines Agency of the Marketing Authorization Application for sebelipase alfa for LAL Deficiency.

23 Dec 2014

IGI Laboratories submits three additional ANDAs to FDA

IGI Laboratories, Inc., a New Jersey based specialty generic pharmaceutical company, today announced it has submitted three additional abbreviated new drug applications (ANDAs) to the U.S. Food and Drug Administration (FDA), which brings the Company's total number of ANDA submissions in 2014 to eleven, with twenty-two submissions now pending at the FDA.

23 Dec 2014

Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

AbbVie receives Health Canada approval for HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir film-coated tablets; dasabuvir film-coated tablets), an all-oral, short-course (12 weeks for the majority of patients), interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with cirrhosis.

23 Dec 2014

Pivotal trial of Elios melanoma vaccine to be conducted at top U.S. cancer hospitals

Elios Therapeutics, LLC recently received FDA approval of its Investigational New Drug (IND) application and its randomized phase IIb trial planned to enroll 120 stage III and IV (resected) melanoma patients to assess the ability of a personalized vaccine to prevent recurrence.

23 Dec 2014

Drug Trial News

Combination therapy can reduce recurrence of small, HER2-positive breast tumors

ContraVir granted Type B meeting with FDA to discuss proposal for FV-100 Phase 3 trial

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

Johnson & Johnson begins Phase 1 trial of preventive Ebola vaccine program

LEO Pharma submits NDA for aerosol foam formulation to treat patients with plaque psoriasis

BrainStorm's phase 2a ALS study meets primary endpoint

FDA receives Actavis' NDA resubmission for cariprazine

Final Phase 1 data of zoptarelin doxorubicin Phase 1/2 trial published in Clinical Cancer Research

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Can-Fite BioPharma completes RA Phase III study of lead drug candidate CF101

G-treeBNT files IND with MFDS for Phase IIB/III clinical trial of RGN-259 for dry eye syndrome

Palatin begins bremelanotide phase 3 study for treatment of female sexual dysfunction

Kinex Pharmaceuticals doses first patient with KX2-361 in ‘A Phase 1’ clinical trial

Actavis receives complete response letter for nebivolol/valsartan FDC for treatment of hypertension

PTC begins rolling NDA submission for Translarna to treat nmDMD

Mirati begins dosage in MGCD265 Phase 1b clinical trial for NSCLC

EMA validates Synageva's sebelipase alfa MAA for LAL Deficiency

IGI Laboratories submits three additional ANDAs to FDA

Abbvie’s HOLKIRA PAK for chronic genotype 1 Hepatitis C treatment receives Health Canada approval

Pivotal trial of Elios melanoma vaccine to be conducted at top U.S. cancer hospitals

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