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Adocia announces positive results from BioChaperone Lispro phase IIa clinical trial

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. [More]
Moffitt Cancer Center initiates phase I clinical trial of cancer vaccine ID-G305

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

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

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. [More]

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

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. [More]

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. [More]
I-SPY 2 trial qualifies neratinib for HER2-positive breast cancer

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. [More]
Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

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

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. [More]
Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

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). [More]

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

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

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. [More]
Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

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. [More]

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

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). [More]
BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

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. [More]
Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis. [More]

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

CardioCell LLC has just received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually. [More]
Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. [More]