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Daily news and top headlines for drug research professionals

FDA Fast Tracks MedImmune’s Pneumonia Drug

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

AstraZeneca announced that its global biologics research and development arm, MedImmune, has received fast track designation from the FDA for its investigational monoclonal antibody MEDI3902 for the prevention of nosocomial pneumonia. Read more...

Ebola Drug Trials to be Fast-Tracked in West Africa

September 23, 2014 10:48 am | News | Comments

Potential new treatments for Ebola are to be tested in West Africa for the first time as part of an international initiative to fast-track trials of the most promising drugs against the disease that has already led to over 2,600 deaths. Read more...

Pterostilbene Prevents Skin Damage from UV Exposure in Mouse Study

September 22, 2014 4:04 pm | News | Comments

ChromaDex Corp. announced the completion of an animal skincare study of pterostilbene by researchers at The University of California Irvine (UCI). Read more...                          

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Metformin Linked to Risk of Low Levels of Thyroid Hormone

September 22, 2014 4:03 pm | News | Comments

Metformin, a commonly used drug for treating type 2 diabetes, is linked to an increased risk of low thyroid-stimulating hormone (TSH) levels in patients with underactive thyroids (hypothyroidism), according to a new study. Read more...      

Amgen Submits BLA for Investigational Cancer Immunotherapy

September 22, 2014 3:54 pm | News | Comments

Amgen announced submission of a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...                

Tekmira’s Ebola Drug Gets Regulatory Framework

September 22, 2014 2:56 pm | News | Comments

Tekmira Pharmaceuticals Corp. announced that the FDA has authorized Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections. Read more...          

Japan Approves Bayer's Eylea for Myopic Choroidal Neovascularization

September 22, 2014 9:58 am | News | Comments

Bayer HealthCare has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of myopic choroidal neovascularization (myopic CNV). Read more...     

Spain: Ebola Test Drug Out of Supply Worldwide

September 22, 2014 9:19 am | News | Comments

Doctors treating a Spanish priest who was repatriated from West Africa on Monday after being diagnosed with the Ebola virus said there were no samples of experimental drug ZMapp available in the world right now. Read more...        

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Soligenix Gets $24.7M for Development of Heat-Stable RiVax Vaccine

September 19, 2014 10:28 am | News | Comments

Soligenix Inc. announced that it has been awarded a contract valued at up to $24.7 million to advance the development of Soligenix’s thermostabilization technology, ThermoVax, combined with the company’s ricin toxin vaccine, RiVax. Read more...  

Gilead Cancer Drug Approved in Europe

September 19, 2014 9:22 am | News | Comments

Gilead Sciences Inc. announced that the European Commission has granted marketing authorization for Zydelig (idelalisib), a first-in-class oral treatment for chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). Read more...     

Afamelanotide Holds Promise as Vitiligo Treatment

September 19, 2014 8:30 am | Videos | Comments

A treatment regimen is safe and effective for restoring skin pigmentation in vitiligo patients, according to a new study. Read more...                                 

EC Approves Xultophy for Adult Diabetes

September 18, 2014 11:03 pm | News | Comments

Novo Nordisk announced that the European Commission has granted marketing authorization for Xultophy for the treatment of type 2 diabetes mellitus in adults. Read more...                       

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:41 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. Read more...                         

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Vaccine Stops Catheter-Linked UTIs in Mice

September 18, 2014 4:13 pm | News | Comments

The most common type of hospital-associated infection may be preventable with a vaccine, new research in mice suggests. The experimental vaccine prevented urinary tract infections associated with catheters. Read more...          

CDC Tells Healthy Adults Not to Forget Flu Vaccine

September 18, 2014 4:08 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

It's time for flu vaccine again and while it's important for the whole family, this year health officials have some different advice for different ages. Read more...                         

Lilly's Combo Treatment Improves OS in Gastric Cancer Patients

September 18, 2014 3:58 pm | News | Comments

Eli Lilly and Co. announced that results of the global Phase 3 trial of ramucirumab (Cyramza) in combination with paclitaxel in patients with advanced gastric (stomach) cancer or gastroesophageal junction (GEJ) adenocarcinoma were published in a sholarly journal. Read more...

Otsuka, NuView Life Sciences Enter Global Licensing Agreement

September 18, 2014 3:50 pm | News | Comments

NuView Life Sciences announced entry into an exclusive global licensing and collaboration agreement with Otsuka Pharmaceutical Co. to further develop and commercialize NuView's investigative genomic-based diagnostic biomarker to detect cancers of the breast and prostate. Read more...

FDA OKs Faster-Acting Label for ED Drug Stendra

September 18, 2014 3:43 pm | News | Comments

Federal regulators have approved a new label for Vivus' impotence drug, stating that it becomes effective in half the time that the previous label had stated. Read more...                       

Texas A&M to Dedicate Key Element of Vaccine Center

September 18, 2014 3:28 pm | News | Comments

Texas Gov. Rick Perry will join other dignitaries in College Station at the dedication of what's described as a national pandemic influenza vaccine facility. Read more...                       

Ryzodeg Offers Glycemic Control With Fewer Injections

September 18, 2014 9:17 am | News | Comments

Data presented by Novo Nordisk show that Ryzodeg (insulin degludec/insulin aspart), administered twice daily, provides successful glycemic control with fewer injections than a basal-bolus regimen. Read more...            

BI, CureVac Collaborate on Next-Gen Lung Cancer Immunotherapy

September 18, 2014 9:09 am | News | Comments

Boehringer Ingelheim and CureVac jointly announced an exclusive global license and development collaboration focusing on CureVac’s CV9202, a novel investigational therapeutic mRNA vaccine in early clinical development for the treatment of lung cancer. Read more...

UK Nurse Will Give Blood to Treat U.S. Ebola Patient

September 18, 2014 9:01 am | by Maria Cheng, AP Medical Writer | News | Comments

A British nurse who survived Ebola has traveled to the United States to donate blood to an American still battling the disease, an experimental measure some scientists think can help patients fight off the virus. Read more...       

Experts Want Limits on Testosterone Drug Use

September 17, 2014 6:39 pm | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans currently taking them. Read more...

Gilead Releases Phase 2 Pancreatic Cancer Data

September 17, 2014 3:28 pm | News | Comments

Gilead Sciences Inc. announced results from a Phase 2 study evaluating simtuzumab, an investigational inhibitor of lysyl oxidase-like-2 (LOXL2), in combination with gemcitabine for patients with previously untreated advanced pancreatic cancer. Read more...

Lilly Sells Failed Oncology Drug to Denovo Biopharma

September 17, 2014 3:18 pm | News | Comments

Denovo Biopharma LLC announced that it has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly and Co. Denovo gains all rights to develop, manufacture and commercialize enzastaurin globally. Read more...           

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