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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

Treatment for stroke: Intra-arterial treatment more effective than standard medical care for clot removal

Study results released today in The New England Journal of Medicine gave the world of stroke care more evidence that physicians are winning the battle against this debilitating disease, which affects as many as one in six people.

23 Dec 2014

Experimental Ebola vaccine safe and immunogenic in African population

Two experimental DNA vaccines to prevent Ebola virus and the closely related Marburg virus [1] are safe, and generated a similar immune response in healthy Ugandan adults as reported in healthy US adults earlier this year.

23 Dec 2014

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer and inflammatory diseases, today announced that it has dosed the first patient in a Phase II trial for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer.

22 Dec 2014

Oncolytics Biotech submits Orphan Designation to EMA for treatment of ovarian, pancreatic cancers

Oncolytics Biotech Inc. ("Oncolytics") today announced that it has submitted applications for Orphan Designation to the European Medicines Agency ("EMA") for REOLYSIN® for the treatment of pancreatic and ovarian cancers.

22 Dec 2014

C3BS enrols 240th patient in CHART-1 European trial of C-Cure for treatment of congestive heart failure

Cardio3 BioSciences, a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today the enrolment of the 240th patient in its CHART-1 European trial for C-Cure, the first and only stem cell therapeutic using guided stem cells for the treatment of congestive heart failure.

19 Dec 2014

$Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis$

Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of immunology and topical products, today announced that 179 patients have completed its 16-week, double-blind, placebo-controlled, Phase 2 clinical trial to investigate the safety and efficacy of WF10 in patients with refractory allergic rhinitis.

18 Dec 2014

Drug Trial News

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

Treatment for stroke: Intra-arterial treatment more effective than standard medical care for clot removal

Experimental Ebola vaccine safe and immunogenic in African population

Can-Fite BioPharma begins dosing in CF102 Phase II liver cancer trial

Oncolytics Biotech submits Orphan Designation to EMA for treatment of ovarian, pancreatic cancers

C3BS enrols 240th patient in CHART-1 European trial of C-Cure for treatment of congestive heart failure

Nuvo Research completes WF10 Phase 2 trial in patients with refractory allergic rhinitis

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