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RSS FeedPosted by Michael Wonder on 21 May 2017
ALPHAEON submits biologics license application for DWP-450 neuromodulator BLA submitted within three years of first patient enrolment
16 May 2017 - ALPHAEON today announced that its wholly-owned subsidiary Evolus, submitted a biologics license application for DWP-450, a Botulinum ...
Posted by Michael Wonder on 21 May 2017
Amgen submits biologics license application to the FDA for erenumab
18 May 2017 - Erenumab is an investigative treatment specifically designed to prevent migraine only molecule in late-stage development to ...
Posted by Michael Wonder on 20 May 2017
European Medicines Agency validates application for Bristol-Myers Squibb’s Sprycel (dasatinib) in children with chronic myelogenous leukaemia
19 May 2017 - Proposal extends application to the treatment of children and adolescents with chronic phase Philadelphia-chromosome positive chronic myelogenous ...
Posted by Michael Wonder on 20 May 2017
Merck receives CHMP positive opinion recommending approval of Isentress (raltegravir) 600 mg in the European Union
19 May 2017 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 20 May 2017
CHMP recommends Veltassa for the treatment of hyperkalaemia in the EU
19 May 2017 - Opinion includes treatment of patients who develop hyperkalaemia while on RAAS inhibitors. ...
Posted by Michael Wonder on 20 May 2017
Brodalumab, a novel biologic for people with moderate-to-severe psoriasis, receives positive opinion from European CHMP
18 May 2017 - LEO Pharma today announced that it received a positive opinion from the European CHMP recommending marketing authorisation ...
Posted by Michael Wonder on 20 May 2017
CO.DON: decisive step towards European expansion
18 May 2017 - Positive opinion from relevant committee for EU approval of articular cartilage product ...
Posted by Michael Wonder on 19 May 2017
Spark Therapeutics completes rolling biologics license application submission to FDA for investigational gene therapy voretigene neparvovec
18 May 2017 - Voretigene neparvovec has the potential to be the first pharmacologic treatment for an inherited retinal disease ...
Posted by Michael Wonder on 19 May 2017
Sage Therapeutics receives fast track designation for SAGE-217 for the treatment of major depressive disorder
18 May 2017 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-217 for ...
Posted by Michael Wonder on 18 May 2017
Bayer receives FDA priority review for investigational anti-cancer compound copanlisib
17 May 2017 - Regulatory submission based on data from the Phase II CHRONOS-1 study, in which copanlisib showed objective response ...
Posted by Michael Wonder on 17 May 2017
Sangamo receives fast track designation from the FDA for SB-525 investigational haemophilia A gene therapy
16 May 2017 - Sangamo Therapeutics announced today that the U.S. FDA has granted fast track designation to SB-525, the Company's ...
Posted by Michael Wonder on 16 May 2017
Aerie Pharmaceuticals announces FDA acceptance of NDA submission for Rhopressa (netarsudil ophthalmic solution) 0.02%
15 May 2017 - PDUFA date set for 28 February 2018. ...
Posted by Michael Wonder on 16 May 2017
Ignyta granted breakthrough therapy designation for entrectinib by U.S. Food and Drug Administration
15 May 2017 - Ignyta today announced that the U.S. FDA has granted a breakthrough therapy designation to entrectinib for ...
Posted by Michael Wonder on 16 May 2017
Imara receives rare paediatric disease designation from FDA for lead product candidate IMR-687 for sickle cell disease
15 May 2017 - Imara announced today that the U.S. FDA has granted rare paediatric disease designation to IMR-687, the ...
Posted by Michael Wonder on 16 May 2017
Biohaven's trigriluzole receives fast track designation from U.S. FDA
15 May 2017 - Potential first-in-class therapy for spinocerebellar ataxia. ...