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RSS FeedPosted by Michael Wonder on 17 Dec 2019
CHMP opined on fewer new medicines in 2019
18 December 2019 - The CHMP issued 66 positive opinions for 'new medicines' in 2019. ...
Posted by Michael Wonder on 17 Dec 2019
Xtandi (enzalutamide) approved by U.S. FDA for the treatment of metastatic castration-sensitive prostate cancer
16 December 2019 - Xtandi is now FDA approved for the treatment of metastatic castration-sensitive prostate cancer in addition to non-metastatic ...
Posted by Michael Wonder on 17 Dec 2019
Health Canada approves new indication for Erleada (apalutamide) for the treatment of metastatic castration-sensitive prostate cancer
16 December 2019 - Janssen announced today that Health Canada, following a priority review, has approved Erleada (apalutamide) for the ...
Posted by Michael Wonder on 17 Dec 2019
Deciphera Pharmaceuticals announces submission of new drug application to U.S. FDA for ripretinib in patients with advanced gastro-intestinal stromal tumours
16 December 2019 - Application is being reviewed under FDA's real-time oncology review pilot program. ...
Posted by Michael Wonder on 17 Dec 2019
Eiger initiates rolling submission of new drug application with FDA for lonafarnib for treatment of progeria and progeroid laminopathies
16 December 2019 - Rolling NDA Submission Planned for Completion in First Quarter 2020. ...
Posted by Michael Wonder on 17 Dec 2019
Rocket Pharmaceuticals receives EMA PRIME eligibility for RP-L102 gene therapy for Fanconi anaemia
16 December 2019 - Milestone gives Fanconi anaemia program all accelerated regulatory tools in U.S. and EU, including FDA regenerative medicine ...
Posted by Michael Wonder on 17 Dec 2019
Kura Oncology receives fast track designation for tipifarnib in HRAS mutant HNSCC and provides enrolment guidance for AIM-HN trial
16 December 2019 - Registration-directed AIM-HN trial expected to complete enrolment in first quarter of 2021. ...
Posted by Michael Wonder on 17 Dec 2019
Salarius Pharmaceuticals receives FDA fast track designation for lead drug candidate, seclidemstat, in relapsed or refractory Ewing sarcoma
16 December 2019 - Phase 1/2 clinical study now underway; Salarius targeting key safety and efficacy data milestones in 2020. ...
Posted by Michael Wonder on 16 Dec 2019
EMA closes out the year with 66 positive opinions for new medicines
17 December 2019 - This figure is grossly overstated. ...
Posted by Michael Wonder on 16 Dec 2019
Avadel Pharmaceuticals receives U.S. FDA approval for Nouress (AV001), a cysteine hydrochloride injection for treating neonate patients requiring total parental nutrition
16 December 2019 - USPTO issues Orange Book-listed patent for Nouress. ...
Posted by Michael Wonder on 16 Dec 2019
Diurnal submits marketing application to European regulators for congenital adrenal hyperplasia treatment
16 December 2019 - Significant opportunity to address unmet patient need, in a market estimated at $250 million. ...
Posted by Michael Wonder on 16 Dec 2019
ITF Pharma announces FDA approval of supplemental new drug application for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis with a percutaneous endoscopic gastronomy feeding tube
13 December 2019 - Tiglutik is the only formulation of riluzole indicated for both oral and PEG tube administration. ...
Posted by Michael Wonder on 16 Dec 2019
Senate confirms Stephen Hahn to head FDA
12 December 2019 - The Food and Drug Administration has been without a permanent commissioner since April, when Dr. Scott Gottlieb ...
Posted by Michael Wonder on 16 Dec 2019
CHMP issues positive opinion to expand Cyramza (ramucirumab) label to include results from RELAY study in patients with metastatic EGFR-mutated non-small cell lung cancer
13 December 2019 - Cyramza in combination with erlotinib recommended for approval in the EU for the first-line treatment of adult ...
Posted by Michael Wonder on 14 Dec 2019
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation
12 December 2019 - The U.S. FDA today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy ...