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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

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.

3 Apr 2014

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.

3 Apr 2014

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.

3 Apr 2014

Jain Foundation's dysferlinopathy clinical study exceeds original goal of 150 patients

The Jain Foundation is delighted to announce that 193 patients have been recruited into the Clinical Outcome Study for Dysferlinopathy (COS), exceeding the original goal of 150 patients.

2 Apr 2014

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

Synthon Biopharmaceuticals today announced the results of a head-to-head comparative program of its antibody-drug conjugate (ADC) SYD985 with Roche's market leading anti-HER2 ADC, T-DM1 (Kadcyla).

2 Apr 2014

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

Antisense Therapeutics Limited is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose).

2 Apr 2014

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that its lead product GRASPA®/ERY-ASP has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML), an aggressive form of blood cancer.

2 Apr 2014

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

Reinforcing its position as a global leader in bringing new therapies to patients with heart and cardiovascular disease, Boston Scientific Corporation (NYSE: BSX) reported favorable results in studies related to cardiac resynchronization therapy (CRT), platinum chromium stent platforms and transcatheter aortic valve replacement (TAVR).

2 Apr 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

Roswell Park Cancer Institute (RPCI) has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a phase II clinical trial that will use a unique and highly precise method of delivering interstitial photodynamic therapy (I-PDT) to recurrent tumors of the head and neck.

2 Apr 2014

Drug Trial News

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

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

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

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

Jain Foundation's dysferlinopathy clinical study exceeds original goal of 150 patients

Synthon’s SYD985 ADC demonstrates anti-tumor activity, outperforms leading anti-HER2 ADC

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

FDA grants orphan drug designation to ERYTECH’s lead product for AML treatment

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

RPCI receives FDA approval to enroll patients in phase II clinical trial using I-PDT approach

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