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DDD Update

Daily news and top headlines for drug research professionals

Pfizer Gets FDA Acceptance of Palbociclib

October 13, 2014 2:35 pm | News | Comments

Pfizer Inc. announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). Read more...                                

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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...

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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...

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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...                        

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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...

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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...

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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...                

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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...

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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...                              

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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...

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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...

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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...

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