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RSS FeedPosted by Michael Wonder on 10 Oct 2020
In landmark international program, HTA agencies around the world access ICER's customisable COVID-19 cost-effectiveness model
9 October 2020 - Leveraging ICER’s new cloud-based Interactive Modeler platform, Quebec’s HTA agency has used the COVID-19 model to inform ...
Posted by Michael Wonder on 10 Oct 2020
Health Canada approves Inqovi (decitabine and cedazuridine) oral therapy for two types of blood cancers, MDS and CMML
8 October 2020 - Oral drug can be taken at home, which may enable some patients to avoid some hospital visits. ...
Posted by Michael Wonder on 09 Oct 2020
Italfarmaco receives FDA rare paediatric disease designation for givinostat in Duchenne muscular dystrophy, announces completed enrolment in EPIDYS Phase 3 trial
9 October 2020 - The Italfarmaco Group provided today an update on the development of givinostat, its proprietary histone deacetylase ...
Posted by Michael Wonder on 09 Oct 2020
NDA filing for Luye Pharma’s anti-depressant drug LY03005 accepted by the U.S. FDA
4 March 2020 - Luye Pharma Group has announced that the U.S. FDA has reviewed and accepted the filing of ...
Posted by Michael Wonder on 09 Oct 2020
New transparency measures for prescription medicines
9 October 2020 - The Australian Government has given approval to proceed with two measures to enhance transparency for prescription ...
Posted by Michael Wonder on 09 Oct 2020
Eton Pharmaceuticals announces acceptance for filing of new drug application for orphan drug dehydrated alcohol injection
8 October 2020 - Application assigned a PDUFA date of 27 May 2021. ...
Posted by Michael Wonder on 09 Oct 2020
MHRA to join Project Orbis
8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...
Posted by Michael Wonder on 09 Oct 2020
BioMarin receives FDA approval of label expansion to allow maximum dose of 60 mg for Palynziq (pegvaliase-pqpz) injection for treatment of adults with PKU
7 October 2020 - New safety and efficacy data out to 3 years for first and only enzyme therapy to treat ...
Posted by Michael Wonder on 09 Oct 2020
U.S. FDA grants rare paediatric disease designation to Cerecin’s investigational drug tricaprilin for the treatment of infantile spasms
8 October 2020 - Cerecin announced that the U.S. FDA has granted rare paediatric disease designation to tricaprilin, an investigational drug ...
Posted by Michael Wonder on 09 Oct 2020
X4 Pharmaceuticals announces fast track designation granted by the FDA to mavorixafor for the treatment of WHIM syndrome
8 October 2020 - X4 Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 08 Oct 2020
Use of real world evidence to support FDA approval of oncology drugs
8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials. ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted by Michael Wonder on 08 Oct 2020
Gilead inks supply agreement with the European Commission for remdesivir
8 October 2020 - Gilead has signed a joint procurement agreement with the European Commission to enable ‘rapid and equitable’ ...
Posted by Michael Wonder on 08 Oct 2020
Y-mAbs’ nivatrotamab for the treatment of patients with neuroblastoma granted orphan drug designation and rare paediatric disease designation by FDA
7 October 2020 - Y-mAbs Therapeutics today announced that the FDA has granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 08 Oct 2020
Budget 2020-21: Improving Access to Medicines – improving administration of the PBS and patient support programs
6 October 2020 - A one page Budget 2020-21 fact sheet that is heavy on political spin and light on hard ...