Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Feb 2019
Finch Therapeutics’ investigational drug CP101 granted breakthrough therapy designation from FDA for recurrent C. difficile infection
8 February 2019 - Designation to accelerate Finch’s efforts to provide an effective therapy for patients fighting recurrent C. difficile infection. ...
Posted by Michael Wonder on 05 Feb 2019
US FDA grants breakthrough therapy designation for potential next-generation RSV medicine MEDI8897
5 February 2019 - Designation based on positive primary analysis of the Phase IIb trial that demonstrated the safety and ...
Posted by Michael Wonder on 30 Jan 2019
Merck receives breakthrough therapy designation from FDA for V114, the company’s investigational 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease, in infants, children, and adolescents
30 January 2019 - Merck today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation ...
Posted by Michael Wonder on 23 Jan 2019
TG Therapeutics receives breakthrough therapy designation from the U.S. FDA for umbralisib for the treatment of marginal zone lymphoma
22 January 2019 - Breakthrough therapy designation granted based on interim data from the marginal zone lymphoma cohort of the UNITY-NHL ...
Posted by Michael Wonder on 17 Jan 2019
Menlo Therapeutics’ serlopitant granted breakthrough therapy designation by FDA for the treatment of pruritus associated with prurigo nodularis
15 January 2019 - Menlo Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for serlopitant for the ...
Posted by Michael Wonder on 15 Jan 2019
BeiGene receives U.S. FDA breakthrough therapy designation for zanubrutinib in mantle cell lymphoma
14 January 2019 - BeiGene today announced that the U.S. FDA has granted breakthrough therapy designation for its investigational Bruton’s tyrosine ...
Posted by Michael Wonder on 08 Jan 2019
Novartis investigational therapy crizanlizumab (SEG101) receives FDA breakthrough therapy designation for the prevention of vaso-occlusive crises in sickle cell disease
8 January 2019 - FDA filing of crizanlizumab anticipated in first half of 2019. ...
Posted by Michael Wonder on 03 Jan 2019
Aadi Bioscience receives breakthrough therapy designation for Tarzifyx (ABI-009) in PEComa indication
3 January 2019 - Aadi Bioscience today announced that its drug Tarzifyx (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received ...
Posted by Michael Wonder on 20 Dec 2018
Chugai's satralizumab receives FDA breakthrough therapy designation for neuromyelitis optica and neuromyelitis optica spectrum disorders
19 December 2018 - Designation is seventh for Chugai originated drug. ...