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Agios begins AG-348 Phase 1 study to treat PK deficiency

Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism (IEM), today announced dose administration of AG-348 in a Phase 1 study in healthy volunteers.

18 Apr 2014

Cancer Research partners with AstraZeneca and Pfizer to create clinical trial for advanced lung cancer

CANCER RESEARCH UK is partnering with pharmaceutical companies AstraZeneca and Pfizer to create a pioneering clinical trial for patients with advanced lung cancer - marking a new era of research into personalised medicines to treat cancer.

17 Apr 2014

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Baxter International Inc. today announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111. BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder.

From Baxter International Inc. 16 Apr 2014

Akebia completes enrollment in ongoing 200-patient Phase 2b study of AKB-6548

Akebia Therapeutics, Inc., a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialization of these products for patients with kidney disease, today announced it has completed enrollment in its ongoing 200-patient Phase 2b study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis.

16 Apr 2014

Effects of PectaSol-C modified citrus pectin in prostate cancer patients to be studied in phase III trial

A phase III clinical trial conducted at the Meir Medical Center in Kfar-Saba, Israel is now recruiting participants to study the effects of dietary supplement PectaSol-C modified citrus pectin (MCP) in controlling prostate specific antigen (PSA) levels in prostate cancer patients.

15 Apr 2014

Obeticholic acid meets primary composite endpoint in Phase III study

Results from an international Phase III study presented today at the International Liver CongressTM 2014 have shown obeticholic acid (OCA) given to patients suffering from Primary Biliary Cirrhosis (PBC) who previously had an inadequate response to, or have been unable to tolerate ursodeoxycholic acid (UDCA), produced meaningful biochemical and clinical improvements. UDCA is the only therapy currently approved to treat PBC.

15 Apr 2014

Vivolux receives FDA clearance to proceed with phase I/II clinical trial of VLX600

Vivolux AB, a drug discovery company specialized in cancer treatment, announced today that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II. VLX600 is one of the company's promising projects, and which was recently published in the journal Nature Communications.

15 Apr 2014

New drug combination proves effective in treating patients with HCV genotype 1

Treatment options for the 170 million people worldwide with chronic Hepatitis C Virus (HCV) are evolving rapidly, although the available regimens often come with significant side effects. Two multi-center clinical trials led by Beth Israel Deaconess Medical Center show promise for a new option that could help lead to both an increase in patients cured with a much more simple and tolerable all oral therapy.

15 Apr 2014

Impax resubmits NDA for RYTARY providing updated safety and stability information

Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA).

11 Apr 2014

Abbott completes enrollment of 3 clinical trials to support approval of Absorb Bioresorbable Vascular Scaffold

Abbott (NYSE: ABT) today announced it has completed enrollment of three clinical trials to support approvals of the company's revolutionary Absorb™ Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China.

10 Apr 2014

BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that Prof. Arnon Nagler, Director of the Hematology Division and Bone Marrow Transplantation Center at Sheba Medical Center, Israel, has received final regulatory approval to evaluate BioLineRx's BL-8040 as a treatment for chronic myeloid leukemia (CML) in a Phase 1/2 clinical study.

10 Apr 2014

Genkyotex’s GKT137831 reverses lung fibrosis in new model of idiopathic pulmonary fibrosis

Genkyotex, the leading developer of selective NOX enzyme inhibitors, announced today the publication of data showing that GKT137831, a first in class NOX1 and 4 inhibitor, was able to reverse lung fibrosis associated with aging in a new model of idiopathic pulmonary fibrosis.

10 Apr 2014

Affimed Therapeutics reports additional results from AFM13 phase 1 study on R/R Hodgkin lymphoma

Affimed Therapeutics AG announced today further results from its phase 1 clinical trial of AFM13 as monotherapy for the treatment of patients with advanced relapsing/refractory (R/R) Hodgkin lymphoma.

10 Apr 2014

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection.

10 Apr 2014

Adocia announces positive results from BioChaperone Lispro phase IIa clinical trial

Adocia announces positive results from a phase IIa clinical trial evaluating its innovative ultra-fast formulation of insulin Lispro in comparison to Eli Lilly’s Humalog commercial insulin. Adocia’s formulation incorporates proprietary BioChaperone technology which enables accelerated absorption of prandial insulins. Humalog, which is now off-patent, has annual sales of USD 2.6 billion.

10 Apr 2014

Moffitt Cancer Center initiates phase I clinical trial of cancer vaccine ID-G305

Moffitt Cancer Center has initiated a phase I clinical trial for a new immunotherapy drug, ID-G305, made by Immune Design. Immunotherapy is a treatment option that uses a person's own immune system to fight cancer. It has several advantages over standard cancer therapies, including fewer side effects and an overall better tolerability. It tends to be most effective in patients who have smaller, localized tumors that have not spread to distant sites.

10 Apr 2014

Forest Laboratories, Almirall receive feedback from FDA regarding fixed dose combination of aclidinium/formoterol

Forest Laboratories, Inc. and Almirall, S.A. today announced that they have recently received feedback from the U.S. Food and Drug Administration (FDA) regarding the fixed dose combination of aclidinium and formoterol.

9 Apr 2014

New data sharing platform to advance cancer research: an interview with Dr. Charles Hugh-Jones, Chief Medical Officer, Sanofi U.S.

Project Data Sphere, LLC (PDS) is an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium (LSC), a group formed by President Bush in 2001 to look at the ways in which different organisations can come together to improve outcomes in cancer research that no individual group could do by itself. The data-sharing platform is one of the projects developed by the group.

From Sanofi 8 Apr 2014

MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

MicroBiome Therapeutics LLC, today announced that data from the company's clinical trial of microbiome modulator NM504 in development for type 2 diabetes and prediabetes has been accepted for a Poster Preview Presentation at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and The Endocrine Society.

8 Apr 2014

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with the FMS-like tyrosine kinase-3 (FLT3)-ITD mutation.

8 Apr 2014

Drug Trial News

Agios begins AG-348 Phase 1 study to treat PK deficiency

Cancer Research partners with AstraZeneca and Pfizer to create clinical trial for advanced lung cancer

Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Akebia completes enrollment in ongoing 200-patient Phase 2b study of AKB-6548

Effects of PectaSol-C modified citrus pectin in prostate cancer patients to be studied in phase III trial

Obeticholic acid meets primary composite endpoint in Phase III study

Vivolux receives FDA clearance to proceed with phase I/II clinical trial of VLX600

New drug combination proves effective in treating patients with HCV genotype 1

Impax resubmits NDA for RYTARY providing updated safety and stability information

Abbott completes enrollment of 3 clinical trials to support approval of Absorb Bioresorbable Vascular Scaffold

BioLineRx to initiate Phase 1/2 clinical trial on new drug candidate for CML treatment

Genkyotex’s GKT137831 reverses lung fibrosis in new model of idiopathic pulmonary fibrosis

Affimed Therapeutics reports additional results from AFM13 phase 1 study on R/R Hodgkin lymphoma

Gilead Sciences announces positive results from LDV/SOF phase 2 studies on HCV infection

Adocia announces positive results from BioChaperone Lispro phase IIa clinical trial

Moffitt Cancer Center initiates phase I clinical trial of cancer vaccine ID-G305

Forest Laboratories, Almirall receive feedback from FDA regarding fixed dose combination of aclidinium/formoterol

New data sharing platform to advance cancer research: an interview with Dr. Charles Hugh-Jones, Chief Medical Officer, Sanofi U.S.

MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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