Blog
RSS FeedPosted by Michael Wonder on 16 Jul 2019
Dicerna receives breakthrough therapy designation for DCR-PHXC for treatment of primary hyperoxaluria type 1
15 July 2019 - FDA recognises primary hyperoxaluria Types 2 and 3 as meeting criteria for a serious or life-threatening disease ...
Posted by Michael Wonder on 17 Jun 2019
Eiger announces breakthrough therapy designation granted by FDA for avexitide for treatment of post-bariatric hypoglycemia
17 June 2019 - Third Eiger pipeline program granted breakthrough therapy designation. ...
Posted by Michael Wonder on 03 Jun 2019
Novartis shows growing strength in lung cancer innovation with new capmatinib investigational data
3 June 2019 - The U.S. FDA recently granted capmatinib breakthrough therapy designation for the treatment of patients with metastatic NSCLC ...
Posted by Michael Wonder on 30 May 2019
Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma
29 May 2019 - Breakthrough therapy designation for copanlisib primarily based on follow-up data from the pivotal Phase II study ...
Posted by Michael Wonder on 23 May 2019
Iovance Biotherapeutics announces breakthrough therapy designation for LN-145 for treatment of advanced cervical cancer patients who have progressed on or after chemotherapy
22 May 2019 - Iovance Biotherapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to Iovance TIL therapy ...
Posted 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 ...