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New Report: Hep C's Decades of Drug Research Failures, Successes

December 18, 2014 5:18 pm | by PhRMA | News | Comments

PhRMA released a new report, "Twenty-Five Years of Progress Against Hepatitis C: Setbacks and Stepping Stones," that examines the scientific challenges and setbacks researchers have faced on the path to developing new medicines with the potential to transform treatment for hepatitis C patients and how these so-called "failures" are an integral part of the drug discovery process. Read more...

Supplement Maker Admits Lying About Ingredients

December 18, 2014 11:03 am | News | Comments

Federal prosecutors say the owner and president of a dietary supplement company has admitted his...

Inovio Initiates DNA Immunotherapy Trial for Cancers

December 18, 2014 10:48 am | News | Comments

Inovio Pharmaceuticals, Inc. announced it has initiated a phase 1 trial of its hTERT DNA...

Enamine, Sanofi Extend Early Drug Discovery Collaboration

December 18, 2014 9:06 am | News | Comments

Enamine and Sanofi extend partnership for early drug discovery. Read more...   ...

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GSK Shingles Vaccine Hits Goal in Major Study

December 18, 2014 9:02 am | News | Comments

GSK announced that a pivotal phase 3 study to assess the efficacy of HZ/su, an investigational vaccine for the prevention of shingles, has met its primary endpoint. Read more...                                 

Rio Organizers Create 'Super Bacteria' Task Force

December 17, 2014 2:12 pm | by Jenny Barchfield - Associated Press | News | Comments

Brazilian organizers of the 2016 Olympics are creating a task force to deal with a so-called "super bacteria" discovered in Olympic sailing waters. Read more...                 

PDI Announces Launch of NGS Test for Cancer Risk Assessment

December 17, 2014 12:07 pm | News | Comments

PDI, Inc. announced that its molecular diagnostics subsidiary, Interpace Diagnostics, has launched its new next-generation sequencing (NGS) ThyGenX test to assist physicians in distinguishing between benign and malignant genotypes in indeterminate thyroid nodules.  Read more...

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FDA Approves First Pathogen Reduction System to Treat Plasma

December 17, 2014 12:02 pm | News | Comments

The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). Read more...

Clementia Launches First Natural History Study of Patients with FOP

December 17, 2014 10:04 am | News | Comments

Clementia Pharmaceuticals announced the initiation of a natural history study in patients with fibrodysplasia ossificans progressiva. Read more...                   

Veloxis Announces Action Against FDA Over Prophylaxis Drug

December 17, 2014 9:54 am | News | Comments

Veloxis Pharmaceuticals announced that it has filed an action in federal district court against the Food and Drug Administration. Read more...                    

14 Charged in Deadly 2012 Meningitis Outbreak

December 17, 2014 9:06 am | by Denise Lavoie - Associated Press | News | Comments

14 former owners or employees of a Massachusetts pharmacy were charged Wednesday in connection with a 2012 meningitis outbreak that killed 64 people. Read more...                 

Hep C: The Fight for a Fair Drug Price

December 16, 2014 2:38 pm | by Ryan Bushey, Associate Editor | Articles | Comments

The price of one pill has placed Gilead Sciences in the middle of a lawsuit. Read more...                             

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Judge Halts Alzheimer's Drug Swap Until July

December 16, 2014 10:49 am | by Associated Press | News | Comments

A federal judge on Monday ordered an Irish drug manufacturer to halt its plans to discontinue its widely used Alzheimer's medication, allegedly in an effort to drive patients to a newer patented drug. Read more...                                                  

'Darwinian' Test Uncovers an Antidepressant's Hidden Toxicity

December 16, 2014 10:14 am | by University of Utah | News | Comments

Because of undetected toxicity problems, about a third of prescription drugs approved in the U.S. are withdrawn from the market or require added warning labels limiting their use. An exceptionally sensitive toxicity test invented at the University of Utah could make it possible to uncover more of these dangerous side effects early in pharmaceutical development so that fewer patients are given unsafe drugs. Read more...

NewGen Therapeutics: Activity of Targeted Anti-Cancer Drug

December 16, 2014 9:47 am | News | Comments

NewGen Therapeutics, Inc. announced the publication of preclinical research strongly supporting NT-113, the company's novel irreversible pan-erbB inhibitor (EGFR, HER2 and HER4), as a potential new treatment for glioblastoma multiforme (GBM), the most common and most aggressive malignant primary brain tumor in adults. Read more...

Pfizer: Breast Cancer Treatment Results

December 16, 2014 9:17 am | News | Comments

Pfizer Inc. announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology.  Read more...             

Scientists Reveal Neurotransmitter Binding-Site Function

December 15, 2014 1:15 pm | by Ellen Goldbaum, University of Buffalo | News | Comments

New research from University at Buffalo scientists will help pharmacologists better understand how drugs work and how to make them more effective. Read more...                 

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Anthera Licenses Japan Rights for Blisibimod to Zenyaku

December 15, 2014 11:11 am | News | Comments

Anthera Pharmaceuticals, Inc. announced that Anthera and Zenyaku Kogyo Co., Ltd. of Tokyo, Japan executed an exclusive license agreement for the development and commercialization of subcutaneous blisibimod in Japan and potentially other countries throughout Asia.  Read more...

Roche Expands CE-IVD Claims For Organ, Tissue Testing

December 15, 2014 10:55 am | News | Comments

Roche announced that the cobas MPX and cobas WNV assays can now be used for testing of human organ and tissue from cadaveric (non-heart beating) donors, expanding the range of approved uses for the cobas 6800/8800 Systems and assays in markets accepting the CE mark. Read more...

OPKO, Pfizer Enter Into Global Agreement for hGh

December 15, 2014 10:44 am | News | Comments

OPKO Health, Inc. and Pfizer Inc. announced that they have entered into a worldwide agreement for the development and commercialization of OPKO’s long-acting hGH-CTP for the treatment of growth hormone deficiency (GHD) in adults and children, as well as for the treatment of growth failure in children born small for gestational age (SGA) who fail to show catch-up growth by 2 years of age. Read more...

J&J Collaborates with Janssen,USAID to Expand Access to MDR-TB Compound

December 12, 2014 11:15 am | News | Comments

Johnson & Johnson today announced that its affiliate Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has signed a Memorandum of Understanding (MOU) representing the intention of the Company along with the United States Agency for International Development (USAID) to step up the fight against the health threat of antibiotic-resistant bacteria. Read more...

TWi Biotechnology Receives FDA Protocols for Gout Drug

December 12, 2014 10:30 am | News | Comments

TWi Biotechnology Inc. has received US FDA and Taiwan FDA approval of a protocol for a Phase 2 clinical trial of gout drug. Read more...                     

Merck Helps Africa Fight Parasitic Worm Disease

December 12, 2014 10:22 am | News | Comments

Merck announced that Ethiopia will receive around 13 million praziquantel tablets in 2015. Read more...                          

Abbott Acquires Veropharm for $305M

December 12, 2014 9:56 am | News | Comments

Abbott announced that it has acquired control of Veropharm, a leading Russian pharmaceutical manufacturer. Read more...                        

Minnesota Board Won't Set Rules on Execution Drugs

December 11, 2014 2:09 pm | by Brian Bakst - Associated Press | News | Comments

Minnesota pharmacy regulators declined Wednesday to set a pioneering policy sought by death-penalty opponents that would explicitly bar the manufacture of lethal drugs for use in executions elsewhere. Read more...        

Merck Advancing Breast Cancer Drug to Mid-Stage

December 11, 2014 11:33 am | by Linda A. Johnson - AP Business Writer | News | Comments

Merck said it will start mid-stage patient tests of Keytruda in the first half of 2015. Read more...                           

Supporting Drug Development Process with Raman Spectroscopy

December 11, 2014 11:25 am | by Kathleen A. Martin, Ph.D., Senior Research Chemist, McCrone Associates, Inc. | Articles | Comments

Raman spectroscopy has steadily gained a wider role in the pharmaceutical industry because of its applicability to several important aspects of drug development and manufacturing. Read more...                         

Actavis Launches Generic Version of Celebrex

December 11, 2014 9:09 am | News | Comments

Actavis plc announced that it has launched a generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer, Inc.  Read more...                                   

Gilead Faces Lawsuit Over Hepatitis C Drug Pricing

December 11, 2014 8:49 am | News | Comments

Gilead has been selling a 12-week treatment of Sovaldi in the United States for approximately $84,000, or $1,000 per pill. Read more...                     

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