February 24, 2014 Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) …
Where Are the Biotechs: Pharma dominates breakthrough therapy designations
37. That’s then number of breakthrough therapy designations (BTDs) that have been awarded since the US Food and Drug Association (FDA) introduced the new designation …
Breakthrough Therapy designation, is it now the only pathway?
Definitely not! Although this was the hype of last week’s FDA/CMS Summit in Washington D.C. when even FDA’s Commissioner Margaret Hamburg spent most of her …
How endpoints can expedite orphan drug approval
In these past months, I have been developing the program for the World Orphan Drug Congress USA and found out that at least a couple …
First ever Breakthrough Therapy drug is approved by FDA
The first FDA-designated breakthrough therapy has been approved by US regulators, it was announced last week. Roche’s Gazyva (obinutuzumab) coupled with chlorambucil was given the …
Catalyst’s Firdapse blessed with FDA Breakthrough Therapy Designation
Catalyst Pharmaceutical Partners has announced that Firdapse, the company’s investigational orphan drug for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), has been granted Breakthrough Therapy …
Orphan drug lands Novartis third breakthrough therapy designation
Novartis has been granted breakthrough therapy designation from the FDA for its orphan drug bimagrumab. The designation is for the treatment of sporadic inclusion body …
Breakthrough drugs in the fast lane to approval
US drug developers have cheered on the introduction of a new regulatory pathway that could slash the time taken for a new drug to be …