Category Archives: Biotech
By Ben Comer | Published: December 13, 2012
Participants in the 23rd Annual NYPF General Assembly last Friday outlined the many challenges facing industry, and the importance of collaboration as a way to move forward.
By Ben Comer | Published: November 14, 2012
How can the emerging field of data science help to fruitfully translate research and discovery into successful drug development? Academics and pharmaceutical executives at Mount Sinai’s School of Medicine discussed ways to build a bridge across the valley of death, and the growing importance of data across all business areas.
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.