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Daily news and top headlines for drug research professionals

FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | News | Comments

AcelRx Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the company's NDA for Zalviso. The CRL contains requests for additional information on the system to ensure proper use of the device. Read more... 

AstraZeneca, QIAGEN Collaborate on Iressa Diagnostic Test

July 28, 2014 12:38 pm | News | Comments

AstraZeneca announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer patients who are suitable for treatment with Iressa. Read more...    

Cancer Drug Shows Promise as Infertility Treatment

July 28, 2014 12:26 pm | News | Comments

Physicians may have a new drug to treat infertility in women with polycystic ovary syndrome, according to a national, multi-center clinical trial. Read more...                          

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HIV Inhibitor May Also Block Herpes Infection

July 28, 2014 12:19 pm | News | Comments

Creating a successful vaccine against two members of the herpes virus family, the sexually transmitted herpes simplex virus 1 (HSV-1) and 2 (HSV-2), has proven to be challenging. But now, a clinical trial, based on an HSV-2 vaccine, is being conducted. Read more...

MedImmune Fights Pediatricians' New Advice

July 28, 2014 12:13 pm | by Lindsey Tanner, AP Medical Writer | News | Comments

A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine. Read more...            

FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | News | Comments

Lorus Therapeutics Inc. announced that the FDA completed its review and cleared the company's IND application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Read more...

Veloxis Gets EU Marketing Authorization for Transplant Drug

July 28, 2014 10:47 am | News | Comments

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. announced that the European Commission (EC) has granted marketing authorization for Envarsus for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). Read more...

AstraZeneca, Roche Collaborate on Companion Diagnostic Test

July 28, 2014 10:41 am | News | Comments

AstraZeneca announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). Read more...

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COSMOS Results Published on World Hepatitis Day

July 28, 2014 10:35 am | News | Comments

Medivir AB announced that results from the phase 2 COSMOS clinical study were published in The Lancet, demonstrating that 92% of genotype 1 chronic hepatitis C virus adult patients treated with simeprevir in combination with sofosbuvir achieved sustained virologic response 12 weeks after the end of treatment. Read more...

Panel Backs Extended Use of Allergan's DME Treatment

July 25, 2014 2:53 pm | News | Comments

Allergan announced that the European Union's Committee for Medicinal Products for Human Use has recommended extending the Marketing Authorization for Ozurdex to treat adult patients with vision loss due to diabetic macular edema. Read more...   

More U.S. Girls Now Getting Cervical Cancer Vaccine

July 25, 2014 2:20 pm | News | Comments

More teen girls are getting a controversial cervical cancer vaccine but the increase isn't much of a bump, the government reported Thursday. Read more...                            

Humira Lifts AbbVie 2.8% in Q2

July 25, 2014 12:00 pm | by The Associated Press | News | Comments

Drugmaker AbbVie Inc.'s second-quarter profit increased nearly 3 percent and beat analysts' expectations, as sales soared for the world's top-selling drug, Humira. Read more...                      

CHMP Recommends MA for Diabetes Drug

July 25, 2014 11:24 am | News | Comments

Novo Nordisk announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted a positive opinion, recommending marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...

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FDA Reviews What Could Be First Biosimilar

July 25, 2014 11:20 am | News | Comments

The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug, nearly five years after Congress passed a law enabling future approval of biosimilars. Read more...

Blood Cancer Drug Gets Positive CHMP Opinion

July 25, 2014 11:09 am | News | Comments

Gilead Sciences Inc. announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for Zydelig, a first-in-class treatment for patients with chronic lymphocytic leukemia and follicular lymphoma. Read more...

Genomics Reveals Mechanism for Malaria Drug Resistance

July 25, 2014 10:58 am | News | Comments

Researchers have uncovered a way the malaria parasite becomes resistant to an investigational drug, a  discovery made at Washington University School of Medicine in St. Louis that also is relevant for other infectious diseases including bacterial infections and tuberculosis. Read more...

Sorafenib, Capecitabine Combo Fails to Meet Endpoint

July 25, 2014 10:49 am | News | Comments

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc., an Amgen subsidiary, announced that an investigational Phase 3 trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival. Read more...

FDA Approves Combo Painkiller from OxyContin Maker

July 24, 2014 2:59 pm | News | Comments

The Food and Drug Administration has approved a new combination pain pill from the maker of OxyContin that is designed to discourage abuse by painkiller addicts. Read more...                     

Gilead Profit More Than Quadruples on Hep C Drug

July 24, 2014 2:55 pm | News | Comments

Gilead Sciences Inc. on Wednesday reported profit that more than quadrupled in its second quarter, topping analysts' expectations on sales of its new breakthrough drug for hepatitis C. Read more...                

GSK Asks Europe to OK Malaria Shot

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

Pharma giant GSK said Thursday it is submitting its malaria vaccine for regulatory approval to the European Medicines Agency. The experimental shot is the most advanced candidate vaccine for malaria but results from previous trials have been disappointing. Read more...

EU Regulator: Morning-After Pill OK for All Women

July 24, 2014 2:48 pm | News | Comments

A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't work in women weighing more than 80 kilograms (176 pounds). Read more...

Merck Kicks Off Phase 3 Study of CMV Antiviral

July 24, 2014 11:18 am | News | Comments

Merck announced that the first patient has been enrolled in a global Phase 3 clinical study that will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants. Read more...

BMS, Ono Collaborate on Immuno-Oncology

July 24, 2014 11:13 am | News | Comments

Bristol-Myers Squibb Co. and Ono Pharmaceutical Co. Ltd. have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. Read more...

Research Shows that One CF Drug Counteracts Another

July 24, 2014 11:08 am | News | Comments

In lab experiments using tissue samples cultured from cystic fibrosis patients, scientists at the UNC School of Medicine and the UNC Marsico Lung Institute have shown that a new CF drug counteracts the intended beneficial molecular effect of another CF drug. Read more...

Gilead, MPP Partner on Access to HIV, Hep C Drug

July 24, 2014 10:56 am | News | Comments

Gilead Sciences Inc. announced at the 20th International AIDS Conference in Melbourne, Australia, a new agreement with the Medicines Patent Pool to expand access to Gilead's investigational drug tenofovir alafenamide for HIV and hepatitis B, contingent on the medicine's U.S. regulatory approval. Read more...

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