Category Archives: IP

Pipeline Report Preview

By Reid Paul | Published: November 14, 2012
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IP Climate Change: Patent Rights Face Headwinds

By Clark Herman | Published: November 6, 2012
The pharmaceutical industry as of late has faced a growing movement against patent protection in favor of providing access to low cost medicines, specifically in developing countries. In Indonesia, the government imposed compulsory licensing on seven drugs used to treat HIV and Hepatitis B in September. In July, China passed a law which grants it power [...]
Also posted in Emerging Markets, Legal, Market Access, Regulatory, pricing | 1 Comment

The Path of Least Resistance: Repositioned Drugs Surpass New Brands

By Clark Herman | Published: October 24, 2012
It was in 1984 when FDA first added the 505(b)(2) pathway for drug approval, a hybrid between the accelerated pathway for generic drug applications, and the standard de novo NDA pathway for proprietary drugs. But in the past 6 years, approvals received through the 505(b)(2) pathway have consistently outnumbered de novo NDAs.
Also posted in Biotech, FDA, R&D, Regulatory, Strategy | Leave a comment

SciClone Pharmaceuticals: Selling Specialty Drugs in China

By Ben Comer | Published: October 1, 2012
US-based SciClone Pharmaceuticals has built its business around selling specialty drugs in China. Companies like Sanofi and Pfizer, despite their own in-country resources, have partnered with SciClone and are achieving better returns, according to SciClone CEO Friedhelm Blobel.
Also posted in Biotech, Emerging Markets, Global, Legal, Manufacturing, People, Regulatory, Sales, Strategy, compliance, healthcare, pricing | Tagged , , | 1 Comment

FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

By Guest Blogger | Published: September 5, 2012
by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]
Also posted in FDA, Guest Blog, Legal, Manufacturing, Market Access, Meetings, Regulatory, Safety, Strategy, Technology | Tagged , | 1 Comment