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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

Inovio begins hTERT DNA immunotherapy trial in adults with breast, lung and pancreatic cancer

Inovio Pharmaceuticals, Inc. announced it has initiated a phase I trial of its hTERT DNA immunotherapy (INO-1400) alone or in combination with Inovio's IL-12 immune activator (INO-9012) in adults with breast, lung, or pancreatic cancer at high risk of relapse after surgery and other cancer treatments.

18 Dec 2014

UK doctors to test cannabis-based medicine for children with severe epilepsy

Children with severe epilepsy could be helped by a new treatment derived from the cannabis plant.

18 Dec 2014

Investigational drug increases PFS in patients with advanced breast cancer

In a groundbreaking study that offers new hope for women with advanced breast cancer, researchers from UCLA's Jonsson Comprehensive Cancer Center have published final clinical trial results that showed the amount of time patients were on treatment without their cancer worsening (called progression-free survival) was effectively doubled in women with advanced breast cancer who took the experimental drug palbociclib.

17 Dec 2014

Study provides new evidence for anti-cirrhotic effects of GENFIT's GFT505

GENFIT, a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that a recent study provides new evidence for anti-cirrhotic effects of GFT505 in the context of NASH.

17 Dec 2014

Isis Pharmaceuticals begins ISIS-DMPK Rx clinical study in DM1 patients

Isis Pharmaceuticals, Inc. announced today that it has initiated a study for ISIS-DMPK Rx in patients with Myotonic Dystrophy Type 1 (DM1). DM1 is a rare genetic neuromuscular disease caused by the production of toxic dystrophia myotonica-protein kinase (DMPK) RNA in cells. ISIS-DMPKRx is specifically designed to reduce toxic DMPK RNA.

16 Dec 2014

Trastuzumab drug improves long-term survival of patients with HER-2 positive breast cancer

VCU Massey Cancer Center physician-researcher Charles E. Geyer, Jr., M.D., was the National Protocol Officer for one component of a large national study involving two National Cancer Institute-supported clinical trials that demonstrated that trastuzumab significantly improves the long-term survival of HER-2 positive breast cancer patients.

16 Dec 2014

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Crealta Pharmaceuticals LLC, today announced that the Journal of Clinical Rheumatology published a comprehensive review of a post-hoc safety analysis that was completed for Krystexxa (pegloticase), including data from the two pivotal randomized Phase III trials and one open-label extension trial.

14 Dec 2014

Drug Trial News

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

Inovio begins hTERT DNA immunotherapy trial in adults with breast, lung and pancreatic cancer

UK doctors to test cannabis-based medicine for children with severe epilepsy

Investigational drug increases PFS in patients with advanced breast cancer

Study provides new evidence for anti-cirrhotic effects of GENFIT's GFT505

Isis Pharmaceuticals begins ISIS-DMPK Rx clinical study in DM1 patients

Trastuzumab drug improves long-term survival of patients with HER-2 positive breast cancer

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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