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Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.

11 Mar 2014

Controlled TB vaccine trial designed to study prevention of Mtb infection by vaccination

Aeras today announced the initiation of the first randomized, controlled tuberculosis (TB) vaccine trial designed to study prevention of Mycobacterium tuberculosis (Mtb) infection by vaccination.

11 Mar 2014

Trophos' olesoxime shows beneficial effect on maintaining motor function in SMA patients

Trophos today announces that top-line results from a pivotal clinical trial of its lead product candidate olesoxime in spinal muscular atrophy (SMA) show a beneficial effect on the maintenance of motor function in SMA patients. If approved, olesoxime could be the first treatment specifically developed for SMA patients.

10 Mar 2014

Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that its lead anti-fibrotic compound FT011 has successfully completed a Phase Ia trial in healthy volunteers demonstrating safety and tolerability up to doses of 1000mg.

10 Mar 2014

Mainstay Medical initiates clinical trial to investigate ReActiv8 as treatment for adults with CLBP

Mainstay Medical today announced that it has secured approval from Ethics Committees in Australia to start a clinical trial of ReActiv8, its innovative implantable neurostimulation device for the treatment of people with Chronic Low Back Pain (CLBP). Recruitment of subjects for the trial has commenced at three clinical sites in Australia.

10 Mar 2014

Edison Pharmaceuticals initiates Phase 2B/3 study of EPI-743 in children with Leigh syndrome

Edison Pharmaceuticals today announced the initiation of a phase 2B/3 study entitled, "A Phase 2B/3 Open-label Study of EPI-743 in Children with Leigh Syndrome" to be conducted in conjunction with Dainippon Sumitomo Pharma Co, Ltd.

10 Mar 2014

Incyte Corporation publishes results of Phase III trial of ruxolitinib in patients with polycythemia vera

Incyte Corporation (Nasdaq: INCY) today announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35 percent or more.

7 Mar 2014

Ludwig, Agenus to advance three monoclonal antibody checkpoint modulators into preclinical development

Ludwig Cancer Research and Agenus Inc. today announced the selection of three monoclonal antibody checkpoint modulators (CPMs) that Agenus is advancing into preclinical development.

7 Mar 2014

Alkermes initiates pivotal clinical development program for treatment of MDD

Alkermes plc today announced the initiation of the pivotal clinical development program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

6 Mar 2014

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.

6 Mar 2014

Merck announces new data from ongoing C-WORTHY Study in HIV/HCV co-infected patients

Merck, known as MSD outside of the United States and Canada, today announced new data from HIV/HCV co-infected patients in the ongoing C-WORTHY Study, a Phase 2 clinical trial evaluating the efficacy and safety of Merck's all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor.

5 Mar 2014

Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

Verastem, Inc., focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063.

5 Mar 2014

Treating cystic fibrosis: an interview with Simon Bedson, Senior Vice President and International General Manager at Vertex

Cystic fibrosis is a rare, life-shortening genetic disease for which there is no cure. It affects more than 75,000 people worldwide. In CF, thick, sticky mucus blocks the passages in many organs, leading to a variety of symptoms. In particular, mucus builds up and clogs airways in the lungs making it easier for bacteria to grow.

5 Mar 2014

Kamada initiates Phase 2/3 clinical trial of Glassia to treat pediatric patients with T1D

Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces the initiation of a Phase 2/3 clinical trial of Glassia®, the Company's proprietary human Alpha-1 Antitrypsin (AAT), to treat newly diagnosed pediatric patients with type 1 diabetes (T1D).

5 Mar 2014

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.

5 Mar 2014

Experimental drug nivolumab shrinks tumors in patients with advanced melanoma

An experimental drug aimed at restoring the immune system's ability to spot and attack cancer halted cancer progression or shrank tumors in patients with advanced melanoma, according to a multisite, early-phase clinical trial at Johns Hopkins Kimmel Cancer Center and 11 other institutions. All patients had experienced disease progression despite prior systemic therapies, and most had received two or more prior treatments.

4 Mar 2014

AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE

Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announced today that they have received orphan drug designation status for their radiopharmaceutical, Gallium-68 DOTATATE.

4 Mar 2014

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Omeros Corporation today announced that it has submitted to the U.S. Food and Drug Administration (FDA) an investigational new drug (IND) application to initiate the Phase 2 clinical program for OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin‑associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.

4 Mar 2014

Oramed to present detailed results from ORMD-0801 Phase 2a trial at 2014 GTC Diabetes Summit

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it will be presenting detailed results from its recently completed Phase 2a FDA trial on ORMD-0801, its orally ingestible insulin capsule at the 2014 GTC Diabetes Summit taking place from April 23-25, 2014, in Boston, Massachusetts, USA.

4 Mar 2014

LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

LFB SA, through its rEVO Biologics subsidiary, announced today initiation of the global Phase 3 program for LR769, a novel recombinant form of human Factor VIIa, in patients with congenital hemophilia A or B with inhibitors.

4 Mar 2014

Drug Trial News

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Controlled TB vaccine trial designed to study prevention of Mtb infection by vaccination

Trophos' olesoxime shows beneficial effect on maintaining motor function in SMA patients

Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Mainstay Medical initiates clinical trial to investigate ReActiv8 as treatment for adults with CLBP

Edison Pharmaceuticals initiates Phase 2B/3 study of EPI-743 in children with Leigh syndrome

Incyte Corporation publishes results of Phase III trial of ruxolitinib in patients with polycythemia vera

Ludwig, Agenus to advance three monoclonal antibody checkpoint modulators into preclinical development

Alkermes initiates pivotal clinical development program for treatment of MDD

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Merck announces new data from ongoing C-WORTHY Study in HIV/HCV co-infected patients

Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

Treating cystic fibrosis: an interview with Simon Bedson, Senior Vice President and International General Manager at Vertex

Kamada initiates Phase 2/3 clinical trial of Glassia to treat pediatric patients with T1D

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

Experimental drug nivolumab shrinks tumors in patients with advanced melanoma

AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE

Omeros submits investigational new drug to initiate OMS721 Phase 2 clinical program

Oramed to present detailed results from ORMD-0801 Phase 2a trial at 2014 GTC Diabetes Summit

LFB SA initiates Phase 3 program for human Factor VIIa in patients with congenital hemophilia

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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