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Daily news and top headlines for drug research professionals

BMS, Pharmacyclics and Janssen Collaborate on Non-Hodgkin Lymphoma Drug

October 13, 2014 2:25 pm | News | Comments

Bristol-Myers Squibb Company, Pharmacyclics Inc., and Janssen Research & Development LLC announced they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica. Read more...

CDC Urges All U.S. Hospitals to Think 'Ebola'

October 13, 2014 2:13 pm | by Connie Cass | News | Comments

The government is telling the nation's hospitals to "think Ebola." Every hospital must know how to diagnose Ebola in people who have been in West Africa and be ready to isolate a suspected case, Tom Frieden, director of the Centers for Disease Control and Prevention, said. Read more...

Scientists Characterize a New Tumor Syndrome

October 13, 2014 11:08 am | News | Comments

Scientists at the Luxembourg Center for Systems Biomedicine (LCSB) of the University of Luxembourg have published their findings that mutations in a gene known as “ARMC5” promote the growth of benign tumors in the adrenal glands and on the meninges: ARMC5 appears to belong to the group of so-called tumour suppressor gene. Read more...

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Concert Pharmaceuticals' Spasticity Drug Gets Positive Reviews

October 13, 2014 10:54 am | News | Comments

Concert Pharmaceuticals Inc. announced Phase 1 data of CTP-354, a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Read more...                        

Phase 2 Study to Evaluate Hepatitis C Drug Combination

October 13, 2014 10:41 am | News | Comments

Medivir AB announced that its partner Janssen recently initiated patient enrolment in a phase 2 study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. Read more...

Unexpected Genetic Link to Autoimmune Disease

October 13, 2014 10:27 am | News | Comments

The mutations were familiar, but the patients’ conditions seemed baffling at first. A team lead by Rockefeller University researchers had linked variations in an immune gene to rare bacterial infections. Read more...

FDA Approves Drug for Chemo-Associated Nausea, Vomiting

October 13, 2014 10:10 am | News | Comments

Helsinn Group and Eisai Inc. announced that the FDA approved Akynzeo for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy Read more...                

Can the U.S. Handle Ebola?

October 13, 2014 9:54 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

A breach of infection control resulting in a Dallas health worker getting Ebola raises fresh questions about whether hospitals truly can safely take care of people with the deadly virus, as health officials insist is possible. Read more...

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Ebola Death Toll Rises to More Than 4,000

October 10, 2014 3:40 pm | by Jonathan Paye-Layleh and Robbie Corey-Boulet | News | Comments

Liberian lawmakers rejected a proposal to grant President Ellen Johnson Sirleaf the power to further restrict movement and public gatherings and to confiscate property in the fight against Ebola. Read more...

FDA Approves First Drug-Coated Angioplasty Balloon Catheter for PAD

October 10, 2014 3:23 pm | News | Comments

The U.S. Food and Drug Administration approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). Read more...                              

Gilead Sciences' Once-Daily Hepatitis C Drug Approved by FDA

October 10, 2014 3:02 pm | News | Comments

Gilead Sciences, Inc. announced that the U.S. FDA has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Read more...

Researchers Begin Study of Ebola Vaccine in Africa

October 10, 2014 2:06 pm | News | Comments

The first study of a possible Ebola vaccine is underway in Africa: University of Maryland researchers say three health care workers in Mali received the experimental shots. Read more...

FDA Approves Drug for Nausea, Vomiting Associated With Chemo

October 10, 2014 12:18 pm | News | Comments

The FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Read more...                                         

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BIT225 Trial Results Show Effective Cure of Hepatitis C

October 10, 2014 10:41 am | News | Comments

Australian drug development company Biotron Ltd. announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. Read more...

Janssen Seeks Approval of Psoriasis Drug

October 10, 2014 10:34 am | News | Comments

Janssen-Cilag International NV (Janssen) announced that a Type 2 Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Read more...

Amgen's ALL Drug Receives FDA Priority Review

October 10, 2014 10:23 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...

The Dwindling Stock of Antibiotics, and What to Do About It

October 10, 2014 10:13 am | by Diana Lutz | News | Comments

The Centers for Disease Control and Prevention has said that at least 2 million Americans are sickened by antibiotic resistant infections each year and survive. Read more...                        

Giant Step Toward New Diabetes Treatment

October 10, 2014 9:55 am | News | Comments

Harvard stem cell researchers announced that they have made a giant leap forward in the quest to find a truly effective treatment for type 1 diabetes, a condition that affects an estimated 3 million Americans at a cost of about $15 billion annually Read more...

Canadian Ebola Vaccine to Be Shipped to Geneva Next Week, WHO Said

October 10, 2014 9:35 am | by Helen Branswell, The Canadian Press | News | Comments

Experimental Ebola vaccine that Canada has donated to the World Health Organization will be shipped to Geneva next week, the global health agency said. Read more...                                   

Shaping the Future of Immunotherapy: Four Trends to Watch

October 10, 2014 8:30 am | by Merrilyn Datta, Ph.D., Chief Commercial Officer, Definiens | Articles | Comments

Just four years after the drug sipuleucel-T was approved for clinical adoption, the field of immunotherapy is on the cusp of a number of exciting advancements. Read more...                           

NIH Invests Nearly $32M to Increase Utility of Biomedical Research Data

October 9, 2014 3:26 pm | News | Comments

Wide-ranging National Institutes of Health grants announced will develop new strategies to analyze and leverage the explosion of increasingly complex biomedical data sets, often referred to as Big Data. Read more...

Cancer Drug Destroys Tumors in Pre-Clinical Trials

October 9, 2014 3:18 pm | News | Comments

Scientists at QIMR Berghofer Medical Research Institute have used an experimental drug produced from the seeds of a rainforest plant to cure solid cancer tumors in preclinical trials. Read more...                     

Endo Intl to Buy Auxilium in Deal Worth $2.6B

October 9, 2014 3:09 pm | News | Comments

Ireland's Endo International is planning to buy Auxilium Pharmaceuticals in a sweetened cash-and-stock deal valued at $2.6 billion a few weeks after Auxilium rejected a lower bid. The Auxilium board embraced the latest offer but its shareholders get to vote on it. Read more...

Purdue Pharma Launches Smaller Dosage of Chronic Pain Patch

October 9, 2014 3:03 pm | News | Comments

Purdue Pharma L.P. announced the U.S. commercial launch of the new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans are now available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. Read more...

New Technique Yields Fast Results in Drug, Biomedical Testing

October 9, 2014 2:50 pm | News | Comments

A new technique makes it possible to quickly detect the presence of drugs or to monitor certain medical conditions using only a single drop of blood or urine, representing a potential tool for clinicians and law enforcement. Read more...       

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