07:00 , Jul 25, 2016 |  BioCentury  |  Regulation

Salvage in psoriasis?

A hint of suicidality risk and insufficient differentiation could mean brodalumab is relegated to the last lines of the biologics for psoriasis. But that might be OK given the meager price Valeant Pharmaceuticals International Inc....
07:00 , Jul 25, 2016 |  BC Week In Review  |  Company News

United Therapeutics sales and marketing update

The U.K.’s NICE issued final draft guidance recommending against Unituxin dinutuximab from United Therapeutics to treat high-risk neuroblastoma in combination with GM-CSF, IL-2 and isotretinoin in patients ages one to 17 whose disease has...
08:00 , Nov 23, 2015 |  BC Week In Review  |  Company News

Clinigen Group, United Therapeutics sales and marketing update

The U.K.’s NICE issued draft guidance recommending against Unituxin dinutuximab from United Therapeutics to treat high-risk neuroblastoma in combination with GM-CSF, IL-2 and isotretinoin in patients ages 12 months to 17 years -- its...
08:00 , Nov 2, 2015 |  BC Week In Review  |  Company News

Cipher, Sun Pharmaceutical, Galephar, Allergan deal

Cipher, Galephar and Sun’s Ranbaxy Pharmaceuticals Inc. subsidiary granted Allergan non-exclusive rights to commercialize a generic version of acne drug Absorica Cip-isotretinoin in the U.S., settling a patent suit. Allergan may begin selling...
07:00 , Aug 24, 2015 |  BC Week In Review  |  Clinical News

Dinutuximab regulatory update

The European Commission approved Unituxin dinutuximab from United Therapeutics to treat high-risk neuroblastoma in patients ages 12 months to 17 years. Specifically, it is indicated in combination with GM-CSF, IL-2 and isotretinoin in patients who...
07:00 , Jun 1, 2015 |  BC Week In Review  |  Clinical News

Unituxin dinutuximab regulatory update

EMA’s CHMP recommended approval of Unituxin dinutuximab from United Therapeutics to treat high-risk neuroblastoma in patients aged 12 months to 17 years. Specifically, it is recommended in combination with GM-CSF, IL-2 and isotretinoin in patients...
07:00 , May 20, 2013 |  BC Week In Review  |  Company News

Ranbaxy news

Generics company Ranbaxy pleaded guilty to felony charges relating to the manufacture and distribution of generic drugs made in violation of cGMP practices at its Indian manufacturing facilities in Paonta Sahib and Dewas. In U.S....
08:00 , Dec 3, 2012 |  BC Week In Review  |  Company News

Cipher, Ranbaxy sales and marketing update

Ranbaxy launched Absorbica Cip-isotretinoin in the U.S. to treat severe recalcitrant nodular acne. The companies could not be reached for details. Ranbaxy has an exclusive license from Cipher to market the product to...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

Epuris regulatory update

Cipher said Health Canada approved an NDS for Epuris Cip-isotretinoin to treat severe, recalcitrant, nodular acne in patients >=12 years. The company said it plans to launch the product in Canada in 2Q13. Ranbaxy...
07:00 , Jun 4, 2012 |  BC Week In Review  |  Clinical News

Absorica regulatory update

FDA approved an NDA from Cipher for Absorica Cip-isotretinoin to treat severe recalcitrant nodular acne. The approval triggers a $9 million milestone payment to Cipher from Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359, Gurgaon, India), which...