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Daily news and top headlines for drug research professionals

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...

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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...

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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...

Developing Multi-Functional Anti-Inflammatory Drugs

July 24, 2014 10:44 am | by Gur Roshwalb, M.D., Chief Executive Officer of Celsus Therapeutics | Articles | Comments

Recent years have witnessed the development of novel, non-steroidal anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs (MFAIDs) focusing has been on one of the most sought-after pharmaceutical targets in inflammation research: the secretory phospholipase A2 family. Read more...

FDA Approves Malignant Hyperthermia Drug

July 23, 2014 2:57 pm | News | Comments

Eagle Pharmaceuticals Inc. announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia, along with the appropriate supportive measures. Read more...      

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Inovio's HPV Immunotherapy Hits Primary Endpoint

July 23, 2014 2:35 pm | News | Comments

Inovio Pharmaceuticals Inc. announced successful results from Phase 2 trial of VGX-3100 in women with biopsy-proven cervical intraepithelial neoplasia 2/3 associated with human papillomavirus types 16 or 18. Read more...         

Oral Cancer Drug May be Potential Alzheimer’s Therapy

July 23, 2014 2:26 pm | News | Comments

Scientists are now reporting new progress on a set of compounds, initially developed for cancer treatment, that shows promise as a potential oral therapy for Alzheimer’s. Read more...                    

Survey Finds Sharp Increase in Teen HGH Use

July 23, 2014 1:31 pm | by David Crary, AP National Writer | News | Comments

Experimentation with human growth hormones by America's teens more than doubled in the past year, as more young people looked to drugs to boost their athletic performance and improve their looks, according to a new survey. Read more...     

FDA Approves Gilead's Zydelig for Three Cancers

July 23, 2014 1:13 pm | News | Comments

The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat chronic lymphocytic leukemia, follicular lymphoma and small lymphocytic lymphoma. Read more...            

Neurotrophic Keratitis Drug Gets Orphan Drug Designation

July 23, 2014 11:26 am | News | Comments

Dompe, a leader in R&D for new therapeutic solutions for the treatment of rare diseases, announced that rhNGF (Recombinant Human Nerve Growth Factor) has been designated as an orphan drug by the American Food and Drug Administration. Read more...

Shire to Spend About $225M on Drug Collaboration

July 23, 2014 11:20 am | News | Comments

The drugmaker Shire plans to spend about $225 million in a joint effort with a privately held, U.S. firm to develop a potential treatment for the rare and life-threatening genetic disorder Hunter syndrom, said the British company Wednesday. Read more...

Biosceptre Posts Positive Results for Basal Cell Carcinoma Drug

July 23, 2014 11:07 am | News | Comments

Biosceptre, the oncology company developing antibody products that target the nf-P2X7 receptor, announced positive results from its Phase 1 trial to assess the safety and tolerability of BIL-010t, a topically administered, highly purified sheep antibody therapy, to treat Basal Cell Carcinoma. Read more...

Galmed Gets IND Clearance for Fatty Liver Treatment

July 22, 2014 2:47 pm | News | Comments

Galmed Pharmaceuticals Ltd. announced that FDA cleared Galmed's Investigational New Drug application, permitting the company to conduct clinical trials of aramchol in the United States for the treatment of fatty liver disorders. Read more...   

Halozyme Resumes Pancreatic Cancer Trial

July 22, 2014 2:37 pm | News | Comments

Halozyme Therapeutics Inc. announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. Read more...               

FDA Fast Tracks New Epilepticus Drug

July 22, 2014 2:26 pm | News | Comments

SAGE Therapeutics announced that the FDA has granted fast track designation to the SAGE-547 development program, which will facilitate the development and expedite the review of the drug candidate. Read more...          

HIV Pills Show More Promise to Prevent Infection

July 22, 2014 1:47 pm | News | Comments

There is more good news about HIV treatment pills used to prevent infection in people at high risk of getting the AIDS virus: Follow-up from a landmark study that proved the drug works now shows that it does not encourage risky sex and is effective even if people skip some doses. Read more...

Easing Drug-Induced Fatty Liver Disease in HIV Patients

July 22, 2014 1:40 pm | News | Comments

The only drug to receive FDA approval for reduction of the abdominal fat deposits that develop in some patients receiving antiviral therapy for HIV infection may also reduce the incidence of fatty liver disease. Read more...        

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