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RSS FeedPosted by Michael Wonder on 06 Oct 2020
Y-mAbs provides regulatory update on omburtamab for the treatment of patients with neuroblastoma
5 October 2020 - Y-mAbs Therapeutics today announced that Y-mAbs has received a Refusal to File letter from the U.S. FDA ...
Posted by Michael Wonder on 06 Oct 2020
Update on SMC remobilisation
2 October 2020 - SMC business recovery following the early stages of the COVID-19 pandemic continues to progress well. ...
Posted by Michael Wonder on 06 Oct 2020
Landmark funding and long-term certainty for innovative medicines for Australian patients, the community and the economy
6 October 2020 - Medicines Australia welcomes the Federal Government’s landmark step to introduce a guaranteed PBS new medicines funding ...
Posted by Michael Wonder on 06 Oct 2020
Hope for ovarian cancer patients with new drug listed on PBS
6 October 2020 - Hundreds of Australian patients with ovarian cancer are being given affordable access to a groundbreaking drug ...
Posted by Michael Wonder on 06 Oct 2020
Improving access to medicines
6 October 2020 - The 2020-2021 Budget creates a landmark PBS New Medicines Funding Guarantee. ...
Posted by Michael Wonder on 06 Oct 2020
1 October 2020 price disclosure - confirmed prices
6 October 2020 - Confirmed 1 October 2020 prices resulting from the 2020 October Cycle of Price Disclosure has now been ...
Posted by Michael Wonder on 06 Oct 2020
FDA announces all time low rates for FY2021 priority review vouchers
5 October 2020 - The US FDA has announced historic low rates for the fiscal year 2021 fees to use ...
Posted by Michael Wonder on 06 Oct 2020
FDA grants GlycoMimetics rare paediatric disease designation for rivipansel for treatment of sickle cell disease
5 October 2020 - GlycoMimetics today announced that the U.S. FDA has granted the Company a rare paediatric disease designation for ...
Posted by Michael Wonder on 05 Oct 2020
ImmunoGen announces FDA breakthrough therapy designation for IMGN632 in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm
5 October 2020 - ImmunoGen today announced that the U.S. FDA has granted breakthrough therapy designation for IMGN632 for the ...
Posted by Michael Wonder on 05 Oct 2020
Import German drug prices to the United States? Nein, danke.
4 October 2020 - Price controls would deny researchers funds for next generation of cures. ...
Posted by Michael Wonder on 05 Oct 2020
EU regulator starts safety review of coronavirus drug
3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...
Posted by Michael Wonder on 05 Oct 2020
CDER proposes withdrawal of approval for Makena
5 October 2020 - Today, the U.S. FDA’s Center for Drug Evaluation and Research proposed that Makena (hydroxyprogesterone caproate injection) ...
Posted by Michael Wonder on 05 Oct 2020
Radiopharmaceutical Lutathera now reimbursed in Quebec for cancer patients with advanced gastro-enteropancreatic neuroendocrine tumours
1 October 2020 - Lutathera is the first and only therapeutic radiopharmaceutical indicated in the treatment of GEP-NETs in Canada. ...
Posted by Michael Wonder on 04 Oct 2020
Ruzurgi now available to Canadian Lambert-Eaton myasthenic syndrome patients
25 September 2020 - Médunik Canada is extremely pleased to announce that its new orphan disease product Ruzurgi (amifampridine) is now ...
Posted by Michael Wonder on 04 Oct 2020
Proposal to transition funded access to dornase alfa to a standard Special Authority
2 October 2020 - PHARMAC is seeking feedback on a proposal to transition the process for obtaining funded access to ...