Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2020
FDA grants breakthrough therapy designation for Roche's CD20xCD3 bispecific cancer immunotherapy mosunetuzumab recognising its potential in follicular lymphoma
14 July 2020 - Tenth breakthrough therapy designation awarded for Roche's haematology medicines. ...
Posted by Michael Wonder on 08 Jul 2020
Concert Pharmaceuticals receives FDA breakthrough therapy designation for CTP-543 for the treatment of alopecia areata
8 July 2020 - Designation based on Phase 2 data demonstrating significant hair regrowth in patients with alopecia areata. ...
Posted by Michael Wonder on 06 Jul 2020
EspeRare receives FDA breakthrough therapy designation for investigational prenatal treatment ER-004 in X-linked hypohidrotic ectodermal dysplasia
6 July 2020 - EspeRare today announced that the U.S. FDA has granted breakthrough therapy designation to investigational ER-004 protein ...
Posted by Michael Wonder on 28 Jun 2020
Axsome Therapeutics receives FDA breakthrough therapy designation for AXS-05 for the treatment of Alzheimer’s disease agitation
26 June 2020 - Axsome now granted two breakthrough therapy designations for AXS-05 for separate CNS indications. ...
Posted by Michael Wonder on 09 Jun 2020
Insmed receives FDA breakthrough therapy designation for brensocatib in patients with non-cystic fibrosis bronchiectasis
8 June 2020 - Full results from phase 2 WILLOW study of brensocatib in non-cystic fibrosis bronchiectasis to be presented at ...
Posted by Michael Wonder on 06 Jun 2020
AiCuris was granted breakthrough therapy designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients
5 June 2020 - AiCuris is currently preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 ...
Posted by Michael Wonder on 18 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 mutant metastatic non-small cell lung cancer
18 May 2020 - Designation based on phase 2 DESTINY-Lung01. ...
Posted by Michael Wonder on 11 May 2020
Enhertu granted breakthrough therapy designation in the U.S. for HER2 positive metastatic gastric cancer
11 May 2020 - Designation based on data from pivotal phase 2 DESTINY-Gastric01 trial. ...
Posted by Michael Wonder on 27 Apr 2020
Takeda announces U.S. FDA breakthrough therapy designation for mobocertinib (TAK-788) for the treatment of NSCLC patients with EGFR exon 20 insertion mutations
27 April 2020 - Designation represents positive progress for a unique patient population in need of targeted therapy options. ...
Posted by Michael Wonder on 09 Apr 2020
Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results. ...
Posted by Michael Wonder on 08 Apr 2020
Acceleron receives FDA breakthrough therapy designation for sotatercept in pulmonary arterial hypertension
8 April 2020 - Sotatercept granted first FDA breakthrough therapy designation in pulmonary arterial hypertension since the Agency established the designation ...
Posted by Michael Wonder on 16 Mar 2020
Lilly receives FDA breakthrough therapy designation for baricitinib for the treatment of alopecia areata
16 March 2020 - Recognition reinforces baricitinib's potential to be the first FDA approved medicine for individuals living with alopecia areata. ...
Posted by Michael Wonder on 11 Mar 2020
Janssen announces U.S. FDA breakthrough therapy designation granted for JNJ-6372 for the treatment of non-small cell lung cancer
10 March 2020 - JNJ-6372, a dual-targeting EGFR-MET bispecific antibody, is being investigated for adults with non-small cell lung cancer EGFR ...
Posted by Michael Wonder on 03 Mar 2020
FDA grants breakthrough therapy designation for Genentech’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
2 March 2020 - There are currently no FDA approved treatments for unclassifiable ILD, a debilitating, severe respiratory condition. ...
Posted by Michael Wonder on 29 Feb 2020
FDA grants breakthrough therapy designation for Debiopharm's novel chemo-radio sensititiser Debio 1143 for front-line treatment of head & neck cancer
27 February 2020 - The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination ...