Blog
RSS FeedPosted by Michael Wonder on 14 May 2019
Celgene Corporation announces Pomalyst granted breakthrough therapy designation from FDA for HIV positive and negative Kaposi sarcoma
13 May 2019 - Celgene plans to submit sNDA by end of 2019. ...
Posted by Michael Wonder on 10 May 2019
Sunovion and PsychoGenics announce that SEP-363856 has received FDA breakthrough therapy designation for the treatment of people with schizophrenia
10 May 2019 - SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first ...
Posted by Michael Wonder on 25 Apr 2019
La Jolla Pharmaceutical announces U.S. FDA’s grant of breakthrough therapy designation for LJPC-0118 for the treatment of severe malaria
24 April 2019 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options ...
Posted by Michael Wonder on 21 Apr 2019
Viela Bio receives U.S. FDA breakthrough therapy designation for inebilizumab for treatment of neuromyelitis optica spectrum disorder
18 April 2019 - Designation based on positive primary analysis of pivotal study, N-MOmentum. ...
Posted by Michael Wonder on 21 Apr 2019
Genfit announces FDA grant of breakthrough therapy designation to elafibranor for the treatment of PBC
18 April 2019 - FDA grants elafibranor breakthrough therapy designation, based on Phase 2 data, for treatment of primary biliary cholangitis ...
Posted by Michael Wonder on 01 Apr 2019
Selumetinib granted US breakthrough therapy designation in neurofibromatosis type 1
1 April 2019 - Selumetinib is a MEK 1/2 inhibitor being co-developed by AstraZeneca and MSD. ...
Posted by Michael Wonder on 28 Mar 2019
Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of major depressive disorder
27 March 2019 - Designation offers potential for expedited development and review. ...
Posted by Michael Wonder on 26 Mar 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukaemia with an IDH1 mutation in adult patients ineligible for intensive chemotherapy
26 March 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) in ...
Posted by Michael Wonder on 26 Mar 2019
Promedior received breakthrough therapy designation from FDA for PRM-151 in idiopathic pulmonary fibrosis
26 March 2019 - Promedior today announced that PRM-151, a novel investigational anti-fibrotic immunomodulator, has been granted breakthrough therapy designation ...
Posted by Michael Wonder on 05 Mar 2019
Stock price effects of breakthrough therapy designation
4 March 2019 - Since 2012, the FDA has awarded ‘breakthrough therapy designation’ to drug candidates in clinical development that ...
Posted by Michael Wonder on 25 Feb 2019
U.S. FDA grants breakthrough therapy designation to Amicus’ AT-GAA in late onset Pompe disease
25 February 2019 - First breakthrough therapy for an investigational treatment in Pompe disease. ...
Posted by Michael Wonder on 23 Feb 2019
When biotechs get breakthrough therapy status, Mr. Market yawns
23 February 2019 - As a biotech consultant, I’ve heard many CEO’s tell me that a “drumbeat of news” is ...
Posted by Michael Wonder on 21 Feb 2019
Modis Therapeutics announces that MT1621 receives breakthrough therapy designation from FDA for the treatment of TK2 deficiency
19 February 2019 - Designation based on compelling data from initial clinical studies and high unmet need in thymidine kinase 2 ...
Posted by Michael Wonder on 15 Feb 2019
CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis
15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for ...
Posted by Michael Wonder on 13 Feb 2019
Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer
28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...