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Daily news and top headlines for drug research professionals

Immunotherapy Shows Early Promise Against Advanced Melanoma

April 9, 2014 10:45 am | News | Comments

A new type of immunotherapy that directs patients’ immune responses toward tumor cell killing, IMCgp100, was well tolerated and showed efficacy in some patients with advanced melanoma in a Phase 1 clinical trial. Read more...        

Pharmacyclics Files Imbruvica Supplemental NDA

April 8, 2014 12:45 pm | News | Comments

Pharmacyclics Inc. announced that it has submitted a sNDA to the FDA based on data from the Phase 3 RESONATE study, a head-to-head comparison of Imbruvica versus ofatumumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Read more... 

Merck Serono Begins Phase 3 NSCLC Trial of Tecemotide

April 8, 2014 10:19 am | News | Comments

Merck Serono announced the initiation of the Phase 3 START2 study, designed to assess the efficacy and safety of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide in patients with advanced Stage III non-small cell lung cancer. Read more...

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Alkermes' Schizophrenia Drug Hits Key Phase 3 Endpoints

April 8, 2014 10:05 am | News | Comments

Alkermes plc announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Read more...                 

New Drug May Benefit Head, Neck Cancer Patients

April 8, 2014 8:30 am | News | Comments

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) may benefit from treatment with the investigational drug dacomitinib if their cancer has no defects in a cell signaling pathway called the PI3K pathway and no signs of excessive inflammation. Read more...

Ambit Initiates Phase 2 Trial of Quizartinib Combo in AML, MDS

April 7, 2014 2:14 pm | News | Comments

Ambit Biosciences announced the initiation of the Phase 2 cohort of a 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 patients, or FLT3-ITD positive AML patients in first relapse. Read more...

Antibody-Drug Conjugate Benefits Melanoma Patients in Phase 1

April 7, 2014 2:00 pm | News | Comments

The investigational drug DEDN6525A, which is a new member of a class of drugs called antibody-drug conjugates, was safe, tolerable, and showed hints of activity against three different forms of melanoma. Read more...          

New Lilly Drug Promising Against Metastatic Breast Cancer

April 7, 2014 1:48 pm | News | Comments

The new oral drug LY2835219, an inhibitor of cyclin-dependent kinases 4 and 6, showed early promise as monotherapy for patients with metastatic breast cancer, particularly for those with hormone receptor-positive disease. Read more...     

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Pfizer's New Breast Cancer Drug Shows Promise

April 7, 2014 8:30 am | by Christopher S. Rugaber, AP Economics Writer | News | Comments

An experimental drug has shown encouraging results in treating advanced breast cancer in an early clinical trial, pharmaceutical giant Pfizer reported Sunday. The drug prevented breast cancer from worsening for 20.2 months in trial. Read more...

Amgen Melanoma Drug Trial Misses OS Endpoint

April 4, 2014 1:22 pm | News | Comments

Amgen announced results from the primary overall survival analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor. Read more...

Halozyme Halts Pancreatic Cancer Trial

April 4, 2014 10:36 am | News | Comments

Halozyme Therapeutics announced that as a result of a recommendation from an independent Data Monitoring Committee, the company is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial in patients with pancreatic cancer. Read more...

Glenmark's Chronic Inflammatory Disease Drug Enters Human Trials

April 3, 2014 1:00 pm | News | Comments

Glenmark Pharmaceuticals announced that its Novel Chemical Entity (NCE) GRC 27864, a potent, selective, and orally bioavailable inhibitor of Microsomal Prostaglandin E synthase-1 (mPGES-1), is entering Phase 1human trials. Read more...   

FDA Accepts Omeros IND App for TMA Treatment

April 3, 2014 12:45 pm | News | Comments

Omeros Corp. announced that its Investigational New Drug (IND) Application to evaluate OMS721 for the inhibition of complement mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). Read more...

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BioDelivery Sciences Opens Phase 3 Trial of Diabetic Neuropathy Gel

April 3, 2014 12:37 pm | News | Comments

BioDelivery Sciences International Inc. announced 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. Read more...       

Fertility Drugs Do Not Increase Breast Cancer Risk

April 3, 2014 12:26 pm | News | Comments

Women who took clomiphene citrate or gonadotropins as a part of fertility treatment did not experience an increased risk for breast cancer over 30 years of follow-up, compared with women who were not treated with these medications, according to a study. Read more...

Gilead Hep C Combo Hits Primary Endpoint in Japan

April 3, 2014 11:10 am | News | Comments

Gilead Sciences announced top-line results from a Phase 3 clinical trial in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. Read more...

Takeda Gets JPMA Suspension Over Candesartan Marketing

April 3, 2014 3:20 am | News | Comments

Takeda Pharmaceutical Co. Ltd. received notice of sanctions imposed by the Japan Pharmaceutical Manufacturers Association (JPMA) for promotional activities regarding Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J). Read more...

FDA Gives Go-Ahead for Phase 2a Trial of CardioCell CHF Stem Cell Therapy

April 2, 2014 3:02 pm | News | Comments

CardioCell LLC has just received the FDA’s investigational new drug (IND) approval for a United States-based, Phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Read more...

Committee Backs Approval of Afrezza, MannKind Oral Diabetes Drug

April 2, 2014 2:23 pm | News | Comments

MannKind Corporation announced that an FDA committee recommend that Afrezza Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 and type 2 diabetes. Read more...         

Tetraphase Receives Fast Track Status for IV, Oral Eravacycline

April 2, 2014 1:57 pm | News | Comments

Tetraphase Pharmaceuticals Inc. announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline. Read more...

Bayer Launches Phase 3 Prostate Cancer Trial

April 2, 2014 10:35 am | News | Comments

Bayer HealthCare announced that the company has begun to enroll patients in a new Phase 3 trial with radium-223 dichloride (Xofigo) to evaluate radium-223 in combination with abiraterone acetate and prednisone/prednisolone. Read more...    

Janssen Hep C Combo Therapy Moves to Phase 3

April 2, 2014 10:21 am | News | Comments

Janssen R&D Ireland announced that two Phase 3 trials are recruiting patients to examine the efficacy and safety of simeprevir in combination with sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection. Read more...

GSK Ends Lung Cancer Immunotherapy Trial

April 2, 2014 9:58 am | News | Comments

GlaxoSmithKline announced the company will stop its current trial of MAGE-A3 in non-small cell lung cancer patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. Read more...

Committee Backs Approval of Cubist Antibiotic for Skin Infection

April 1, 2014 2:34 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic Sivextro (tedizolid phosphate). Read more...

Sanofi-Regeneron Cholesterol Drug Excels in Japanese Trial

April 1, 2014 10:24 am | News | Comments

Sanofi and Regeneron announced that the first Phase 2 study with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), in Japanese patients met its primary endpoint. Read more...     

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