Drug Development Pharma - November 11, 2014
Ebola Drug Nears Approval
An influenza drug created by Japan’s Fujifilm Holding Corp. could be approved to treat Ebola by the end of this year. The drug, Avigan, already has been used in Norway, France, Germany and Spain to treat Ebola patients. It was approved in Japan earlier this year to counter new forms of influenza. “So far, four […]
Drug Development Pharma - October 21, 2014
Clanotech receives orphan drug designation in the EU
Clanotech AB’s anti-fibrotic and anti-angiogenic candidate drug CLT-28643 has received orphan drug designation by the European Medicines Agency (EMA) for prevention of scarring post glaucoma filtration surgery. Clanotech’s lead substance, an α5β1-integrin antagonist, has anti-angiogenic, anti-fibrotic and anti-inflammatory properties that are expected to benefit the wound healing processes following glaucoma surgery, according to the company. […]
Drug Development Pharma - October 17, 2014
FIT Biotech to develop Ebola vaccine
Finnish biotechnology company FIT Biotech Oy will together with Icosagen AS develop a new Ebola vaccine. The product development work is based on patented technologies allowing induction of passive and active immunotherapy, states FIT Biotech. The parties will also collaborate with international partners from France and Switzerland. The clinical stage is exepected to start at […]
Drug Development Pharma - October 13, 2014
Orexo applies for expanded label of ZUBSOLV
The Uppsala-based company has submitted an application to the U.S. Food and Drug Administration for an expanded label of ZUBSOLV. Orexo hopes to include initiation of treatment for opioid dependence. The company now anticipates a potential approval of the expanded label during the third quarter 2015. “The FDA submission constitutes an important milestone for ZUBSOLV. Today we take […]
Drug Development Pharma - September 23, 2014
Oxabact granted EMA orphan drug designation
OxThera AB’s product Oxabact has been granted an Orphan Drug Designation in the European Union for treatment of Short Bowel Syndrome (SBS). Oxabact is an oral product composed of highly concentrated live bacteria (Oxalobacter formigenes). OxThera is currently pursuing a clinical development program in the EU and in the US for the treatment of patients suffering from Primary […]
Drug Development Pharma - August 19, 2014
No investigation of Brilinta
The United States Department of Justice has announced that it closes its investigation into PLATO clinical trial for AstraZeneca’s Brilinta. In the PLATO study, Brilinta (ticagrelor) was compared to clopidrogel combined with acetylsalicylic acid. The studied showed that ticagrelor reduced cardiovascular events better than the rival. The Department of Justice started an investigation in October 2013 […]