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Daily news and top headlines for drug research professionals

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...         

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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...

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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...     

Bayer Launches Phase 3 Blood Clot Drug Trials

April 1, 2014 9:50 am | News | Comments

Bayer HealthCare and its U.S. development partner Janssen Research & Development LLC announced the initiation of two new Phase 3 trials to evaluate rivaroxaban in medically-ill patients and children at high risk for blood clots. Read more...

Daiichi Sankyo Initiates Phase 3 Edoxaban Study

April 1, 2014 9:26 am | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has started enrolling patients into the ENSURE-AF multinational Phase 3 study, which will evaluate edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation undergoing electrical cardioversion. Read more...

Halozyme’s Diabetes Drug Meets Primary Endpoint

March 31, 2014 3:54 pm | News | Comments

Halozyme Therapeutics Inc. announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. Read more...                            

Isis Antisense Drug Effectively Lowers Triglycerides in Phase 2

March 31, 2014 3:49 pm | News | Comments

Isis Pharmaceuticals Inc. announced the final results from its Phase 2 study of ISIS-APOCIIIRx in patients with high to severely high triglycerides on stable doses of fibrates. Read more...                  

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Janssen Expands Global Cardiovascular Research with Three New Xarelto Studies

March 31, 2014 3:42 pm | News | Comments

Janssen Research & Development LLC (Janssen) announced it is adding three new clinical trials to its EXPLORER global cardiovascular research program for Xarelto, the most studied and broadly indicated oral Factor Xa inhibitor in the world. Read more...

Studies Find New Drugs Greatly Lower Cholesterol

March 31, 2014 3:21 pm | by Marilynn Marchione , AP Chief Medical Writer | News | Comments

A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been used for this for decades. Read more...

Novartis Ends Heart Drug Trial on Effectiveness

March 31, 2014 10:14 am | News | Comments

Novartis said it's cutting off late-stage research into a potential chronic heart failure treatment because the drug has proven so effective, sending shares to an all-time high when markets opened Monday. Read more...         

Prana Alzheimer’s Drug Misses Primary Endpoint in Phase 2

March 31, 2014 10:10 am | News | Comments

Prana Biotechnology announced that its lead Alzheimer's drug candidate, PBT2, did not meet its primary endpoint of a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer’s disease patients. Read more...

Idera Posts Positive Data in Phase 2 Psoriasis Trial

March 28, 2014 2:27 pm | News | Comments

Idera Pharmaceuticals Inc. announced positive top-line data from its randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. Read more...            

Oramed's Oral Insulin Trial Hits Phase 2a

March 28, 2014 10:50 am | News | Comments

Oramed Pharmaceuticals Inc. announced that the first patient has been enrolled in its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801, in the treatment of type 1 diabetes (T1DM).  Read more...         

Pfizer Cholesterol Drug Hits Main Trial Goal

March 27, 2014 3:22 pm | News | Comments

Pfizer Inc. announced the Phase 2b results of a study of investigational bococizumab, the proposed generic name for RN316. The study met its primary endpoint across all doses, showing that bococizumab significantly reduced low density lipoprotein cholesterol (LDL-C). Read more...

Novartis Treatment Promising Against Drug-Resistant Lung Cancer

March 27, 2014 10:48 am | News | Comments

Novartis published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate of 58% and a median progression-free survival of seven months in adults with advanced anaplastic lymphoma kinase positive non-small cell lung cancer. Read more...

New Cancer Drug Targets CEA Protein

March 27, 2014 10:17 am | News | Comments

A new cancer drug, based on further development of a discovery originally made by Cancer Research UK, has entered a clinical trial to target a wide range of cancers. Read more...                      

Pfizer's Genotropin Hits Phase 3b Endpoints

March 26, 2014 2:09 pm | News | Comments

Pfizer Inc. announced the top-line results from a Phase 3b study evaluating the 24-month efficacy of Genotropin (somatropin) on the height in small-for-gestational-age (SGA) children 24 to 30 months old. Read more...           

Drugs for Terminally Ill Clear New Hurdle

March 26, 2014 1:05 pm | News | Comments

A proposal to allow terminally ill people access to drugs that are still completing clinical trials cleared its first test in the Colorado Legislature on Tuesday. Read more...                      

AM-Pharma Announces Phase 1 AKI Drug Data

March 26, 2014 12:15 pm | News | Comments

AM-Pharma B.V. announced the results of its Phase 1 trial with of recAP (recombinant human Alkaline Phosphatase), showing that both single and multiple ascending doses are safe and well tolerated. Read more...          

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