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...
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...
08:00 , Feb 6, 2012 |  BC Week In Review  |  Clinical News

Cip-isotretinoin regulatory update

Cipher said Health Canada accepted for review an NDS for Cip-isotretinoin to treat acne. The company expects a decision from the agency in 1Q13. Cipher licensed Cip-isotretinoin from Galephar Pharmaceutical Research Inc. (Juncos, Puerto Rico)....
08:00 , Jan 2, 2012 |  BC Week In Review  |  Clinical News

Cip-isotretinoin regulatory update

Cipher said FDA accepted an amendment to an NDA for Cip-isotretinoin to treat severe, nodular acne. The agency designated the amendment a Class 2 resubmission, with a PDUFA date of May 29. The amendment, submitted...
08:00 , Dec 5, 2011 |  BC Week In Review  |  Clinical News

Cip-isotretinoin regulatory update

Cipher submitted to FDA an amendment to its NDA for Cip-isotretinoin to treat severe, nodular acne. The company expects a 6-month review for the application. Cipher said the amendment includes data from a double-blind, North...
07:00 , Oct 3, 2011 |  BioCentury  |  Finance

Value verification

Buysiders are looking for strong data from a handful of high-profile compounds to drive their returns this quarter and to improve their 2011 performance. Infectious disease company Pharmasset Inc. provided a head start on the last...
07:00 , Jul 4, 2011 |  BioCentury  |  Finance

3Q Financial Markets Preview: Flavored with Phase III

The upcoming clinical and regulatory calendar isn't as densely packed as it was in the first half. But biotech investors are looking especially to Phase III data across all market cap segments through year end. Among...
07:00 , Jun 27, 2011 |  BC Week In Review  |  Clinical News

Cip-isotretinoin: Phase III data

Top-line data from the per protocol (PP) population (n=813) of a double-blind, North American Phase III trial showed that Cip-isotretinoin met the co-primary endpoints of non-inferiority to an undisclosed marketed isotretinoin product in the change...