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Daily news and top headlines for drug research professionals

FDA Approves Inhalable Diabetes Drug Afrezza

June 30, 2014 10:40 am | News | Comments

The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication - Afrezza, an insulin powder, that comes in a single-use cartridge - to help patients control their blood sugar levels during meals. Read more...

DVT/PE Drug Receives Positive CHMP Opinion

June 27, 2014 2:11 pm | News | Comments

Pfizer and Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that Eliquis be granted marketing authorization for the treatment of DVT and PE, and the prevention of recurrent DVT and PE, in adults. Read more...

Essentialis Doses First Patient in Prader-Willi Study

June 27, 2014 1:46 pm | News | Comments

Essentialis announced the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients. Read more...   

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BMS Hep C Drug Gets Positive CHMP Opinion

June 27, 2014 1:41 pm | News | Comments

BMS announced that CHMP of the EMA has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic HCV infection in adults. Read more...

Scientists Use Cancer Drug in Gene Therapy

June 27, 2014 1:28 pm | News | Comments

Scientists working to make gene therapy a reality have solved a major hurdle - how to bypass a blood stem cell’s natural defenses and efficiently insert disease-fighting genes into the cell’s genome - with rapamycin, which is commonly used to slow cancer growth and prevent organ rejection. Read more...

EU Panel OKs Expanded Use of Roche Cancer Drug

June 27, 2014 11:10 am | News | Comments

Roche announced that the EU Committee for Medicinal Products for Human Use recommended that the European Commission approve the use of Avastin in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy. Read more...

Gilead Submits Sofosbuvir NDA in Japan

June 27, 2014 11:01 am | News | Comments

Gilead announced that the company has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for approval of sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection. Read more...       

CHMP Recommends Bayer Drug for Gastrointestinal Stromal Tumors

June 27, 2014 10:54 am | News | Comments

The oncology compound regorafenib (Stivarga) from Bayer has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors. Read more...

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Lilly-BI Compound is First Biosimilar Insulin Backed by CHMP

June 27, 2014 10:41 am | News | Comments

The investigational compound LY2963016, a new insulin glargine product from Eli Lilly and Co. and Boehringer Ingelheim for the treatment of type 1 and type 2 diabetes, is the first biosimilar insulin recommended for approval in the EU. Read more...

Some Aggressive Cancers May Respond to Anti-Inflammatory Drugs

June 26, 2014 7:25 pm | News | Comments

New research raises the prospect that some cancer patients with aggressive tumors may benefit from a class of anti-inflammatory drugs used to treat rheumatoid arthritis. Read more...                   

BI’s Pradaxa Antidote Gets FDA Breakthrough Status

June 26, 2014 2:12 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals Inc. announced that the FDA has granted Breakthrough Therapy Designation to idarucizumab, an investigational fully humanized antibody fragment, or Fab, being studied as a specific antidote for Pradaxa. Read more...

AbbVie Initiates New Veliparib Trial in Advanced Breast Cancer

June 26, 2014 2:01 pm | News | Comments

AbbVie announced the initiation of a Phase 3 clinical trial of its investigational compound, veliparib, when added to carboplatin and paclitaxel, two chemotherapeutic medicines, in patients with advanced breast cancer. Read more...      

FDA Warns of Allergic Reactions With Acne Products

June 26, 2014 1:05 pm | by Matthew Perrone, AP Health Writer | News | Comments

Federal health officials are warning consumers who use popular anti-acne treatments about rare but potentially deadly allergic reactions that can cause swelling of the face and difficulty breathing. Read more...            

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Flu Spray Better Than Shots for Young Kids

June 26, 2014 12:57 pm | by Mike Stobbe, AP Medical Writer | News | Comments

When it comes to flu vaccines, a federal panel says a squirt in the nose is better than a shot in the arm for young children. The advisory panel voted Wednesday to advise doctors that FluMist nasal spray is a bit better at preventing flu in healthy young kids. Read more...

FDA Committee Rejects Cancer Drug Accelerated Approval

June 26, 2014 10:37 am | News | Comments

AstraZeneca announced that the FDA Oncologic Drugs Advisory Committee voted 11 to 2 that current evidence does not support an accelerated approval for use of olaparib as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer with germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy. Read more...

Ampio Reduces Patient Sample Size in Eye Study

June 25, 2014 2:05 pm | News | Comments

Ampio Pharmaceuticals Inc. announced that it has informed the Transplant and Ophthalmology Division of the FDA of its intent to reduce the patient sample size in the OptimEyes Study for the treatment of Diabetic Macular Edema (oral treatment with Optina). Read more...

Isis Earns $1M from GSK for Advancing Antisense Drug

June 25, 2014 1:58 pm | News | Comments

Isis Pharmaceuticals Inc. announced that it has earned a $1 million milestone payment from GlaxoSmithKline related to the advancement of the Phase 2/3 study of ISIS-TTRRx, an antisense drug, in patients with familial amyloid polyneuropathy (FAP). Read more...

Eradication of Gut Methane Improves Insulin Sensitivity, Lipid Profiles

June 25, 2014 1:51 pm | News | Comments

Synthetic Biologics Inc., announced that researchers at Cedars-Sinai Medical Center found that eradication of breath methane and reduction of intestinal levels of the most common methanogenic bacterium in the human gut (M. smithii) resulted in improved insulin sensitivity and a reduction in total cholesterol and LDL cholesterol levels in pre-diabetic, obese human subjects. Read more...

Court Upholds Shire Vyvanse Patents

June 25, 2014 11:15 am | News | Comments

Shire plc announced that a U.S. District Court for the District of New Jersey judge granted Shire’s summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse were both infringed and valid. Read more...

Prosensa Completes Enrollment in Natural History Study of DMD

June 25, 2014 11:06 am | News | Comments

Prosensa Holding N.V. announced the successful completion of enrollment in its prospective Natural History Study designed to increase the understanding of Duchenne muscular dystrophy (DMD). Read more...               

BI Launches Nintedanib EAP for Idiopathic Pulmonary Fibrosis

June 25, 2014 10:42 am | News | Comments

Boehringer Ingelheim announced that the company has initiated an open-label, U.S. multi-center expanded access program for its investigational compound nintedanib, for people diagnosed with idiopathic pulmonary fibrosis. Read more...     

BMS Says Cancer Drug Hit Goal in Study

June 24, 2014 7:23 pm | News | Comments

Bristol-Myers said Tuesday that its skin cancer drug nivolumab worked in a late-stage clinical trial, leading the drugmaker to end the study early. Bristol-Myers said patients treated with nivolumab lived longer than patients who received only chemotherapy. Read more...

First GI Microbiome Modulator Improves Blood Sugar

June 24, 2014 2:52 pm | News | Comments

In adults with prediabetes, a new drug that alters microbial populations and their environment in the gastrointestinal (GI) tract improves glucose tolerance — the body’s response to consuming carbohydrates — after four weeks of treatment and without a change in diet. Read more...

U.S. Patent Office Grants Allowance for Advaxis Cancer Immunotherapy Patent Applications

June 24, 2014 2:41 pm | News | Comments

Advaxis Inc., a clinical-stage biotechnology company developing cancer immunotherapies, has received notice of allowance from the United States Patent and Trademark Office (USPTO) on two patents covering the composition and methods of use for ADXS-cHER2. Read more...

CF Foundation Applauds Positive Results of Ivacaftor, Lumacaftor Combo

June 24, 2014 2:36 pm | News | Comments

The Cystic Fibrosis Foundation applauds the successful results - significant improvements in lung function and other key measures of the disease - of Phase 3 studies of ivacaftor (Kalydeco) in combination with lumacaftor (VX-809) for people with two copies of the F508del mutation of cystic fibrosis (CF). Read more...

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