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    Karina Kusova Clinical Development, Market Access, Orphan Drug Congress, Supply Chain & Manufacturing, Uncategorized, Whitepapers May 3, 2017
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    Karina Kusova Advocacy, Clinical Development, Market Access, Orphan Drug Congress, Orphan Drugs Live October 10, 2016

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breakthrough therapy

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Bristol-Myers Squibb Receives FDA Breakthrough Therapy Designation for Hep C Combination Therapy

In Press Release by CameronFebruary 25, 2014Leave a Comment

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) …

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Where Are the Biotechs: Pharma dominates breakthrough therapy designations

In Regulation & Government by CameronJanuary 17, 2014Leave a Comment

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 …

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Breakthrough Therapy designation, is it now the only pathway?

In Regulation & Government by André SingerJanuary 6, 2014Leave a Comment

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 …

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How endpoints can expedite orphan drug approval

In Advocacy, Clinical Development, Regulation & Government by André SingerDecember 5, 2013Leave a Comment

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

In Clinical Development, Regulation & Government by Tim PeplowNovember 7, 2013Leave a Comment

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

In Clinical Development, Regulation & Government by Tim PeplowAugust 28, 2013Leave a Comment

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

In Regulation & Government by Tim PeplowAugust 20, 2013Leave a Comment

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

In Clinical Development, Regulation & Government by Tim PeplowJuly 29, 2013Leave a Comment

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 …

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