Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 10 Aug 2022
Overall survival, progression-free survival and tumour response benefit supporting initial US FDA approval and indication extension of new cancer drugs, 2003-2021
10 August 2022 - Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains ...
Posted by Michael Wonder on 10 Aug 2022
EU regulator begins review of Pfizer-BioNTech's variant adapted COVID shot
9 August 2022 - The EMA has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, ...
Posted by Michael Wonder on 10 Aug 2022
Few U.S. patients with hepatitis C get timely treatment, CDC says
9 August 2022 - Few U.S. adults diagnosed with hepatitis C virus infection receive timely treatment with anti-viral drugs, the ...
Posted by Michael Wonder on 10 Aug 2022
FDA authorises emergency use of Jynneos vaccine to increase vaccine supply
9 August 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Jynneos vaccine to allow health care ...
Posted by Michael Wonder on 09 Aug 2022
Has the innovative pharmaceutical industry essential given up trying to list new medicines in New Zealand?
10 August 2022 - Upon examining the agenda for this month's PTAC meeting, one would think that it has. ...
Posted by Michael Wonder on 09 Aug 2022
Network collaborators announced for CADTH’s post-market drug evaluation network
8 August 2022 - CADTH is pleased to announce the successful collaborators of its inaugural Post-Market Drug Evaluation Network. ...
Posted by Michael Wonder on 09 Aug 2022
Challenges of health technology assessment in pluralistic healthcare systems: an ISPOR Council report
9 August 2022 - Health technology assessment has been growing in use over the past 40 years, especially in its impact ...
Posted by Michael Wonder on 09 Aug 2022
Paladin Labs announces Health Canada's filing acceptance of cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy
8 August 2022 - Paladin Labs announced today that Health Canada has accepted its new drug submission for cenobamate tablets as ...
Posted by Michael Wonder on 09 Aug 2022
Introducing CADTH’s RWE Guidance Working Group
9 August 2022 - CADTH is pleased to announce the introduction of the Real-World Evidence Guidance Working Group. ...
Posted by Michael Wonder on 09 Aug 2022
Relmada Therapeutics receives FDA fast track designation for REL-1017 as a monotherapy for the treatment of major depressive disorder
9 August 2022 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation to REL-1017, the Company's ...
Posted by Michael Wonder on 09 Aug 2022
CorMedix announces regulatory and manufacturing updates
8 August 2022 - CorMedix today announced a second complete response letter was received from the FDA stating that the DefenCath ...
Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023. ...
Posted by Michael Wonder on 08 Aug 2022
Monkeypox vaccines: here’s how many have been shipped and where as White House declares public health emergency
8 August 2022 - The US Government has shipped more than 602,000 doses of Jynneos monkeypox vaccines—the only shot specifically approved ...
Posted by Michael Wonder on 08 Aug 2022
Monkeypox vaccines have arrived in Victoria. Here's how the rollout will work.
9 August 2022 - As concern about how to curb monkeypox continues at a global level, the first few thousand ...
Posted by Michael Wonder on 08 Aug 2022
The GOP blocked an insulin price cap: What it means for diabetics
8 August 2022 - The Senate passed a sweeping budget package Sunday intended to bring financial relief to Americans, but ...