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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

Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor.

8 Apr 2014

I-SPY 2 trial qualifies neratinib for HER2-positive breast cancer

In an innovative clinical trial led by UC San Francisco, the experimental drug neratinib along with standard chemotherapy was found to be a beneficial treatment for some women with newly diagnosed, high-risk breast cancer.

8 Apr 2014

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia 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 Phase 2 cohort of the MD Anderson Cancer Center-sponsored Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse.

7 Apr 2014

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

OncoSec Medical Inc., a company developing its ImmunoPulse DNA-based immunotherapy to treat solid tumors, will re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under a protocol amendment.

7 Apr 2014

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Oncothyreon Inc. today announced that Merck KGaA, Darmstadt, Germany, has initiated the international Phase 3 START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

7 Apr 2014

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

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7 Apr 2014

Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double‐masKed Uveitis tReAtment) Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU), met its primary endpoint.

From Santen Pharmaceutical Co., Ltd. 7 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

Novartis to present early stage data on 19 investigational compounds at AACR annual meeting

Novartis announced today that early stage data on 19 investigational compounds in its oncology pipeline will be presented at the annual meeting of the American Association of Cancer Research, April 5-9, 2014 in San Diego, CA.

4 Apr 2014

Neurovance closes $6.3M extension to its series A1 financing round to advance development of EB-1020 SR

Neurovance, Inc. today announced that it has closed a $6.3 million extension to its series A1 financing round to further advance development of EB-1020 SR, a non-stimulant, for the treatment of all subtypes of adult ADHD (attention deficit hyperactivity disorder).

3 Apr 2014

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Drug Trial News

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

Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

I-SPY 2 trial qualifies neratinib for HER2-positive breast cancer

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

OncoSec Medical to re-launch Phase II cutaneous T-cell lymphoma trial under protocol amendment

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Novartis to present early stage data on 19 investigational compounds at AACR annual meeting

Neurovance closes $6.3M extension to its series A1 financing round to advance development of EB-1020 SR

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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