Blog
RSS FeedPosted by Michael Wonder on 24 Aug 2021
Optimising the data available via Health Canada’s clinical information portal
23 August 2021 - Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast ...
Posted by Michael Wonder on 24 Aug 2021
FDA grants breakthrough device designation for renal failure
23 August 2021 - ImpediMed is pleased to announce SOZO has received FDA breakthrough device designation for a proposed indication ...
Posted by Michael Wonder on 23 Aug 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full U.S. FDA approval for individuals 16 years and older
23 August 2021 - Comirnaty is the first COVID-19 vaccine to be granted FDA approval. ...
Posted by Michael Wonder on 23 Aug 2021
Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of Korsuva (difelikefalin) injection for the treatment of moderate to severe pruritus in hemodialysis patients
23 August 2021 - Promotional launch of Korsuva injection in the U.S. is expected in Q1 2022, with reimbursement in H1 ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 23 Aug 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Orencia (abatacept) for the prevention of acute graft versus host disease
23 August 2021 - The sBLA is supported by the Phase 2 ABA2 trial evaluating Orencia in adults and children to ...
Posted by Michael Wonder on 23 Aug 2021
Estimands, estimators and estimates
23 August 2021 - The primary goal of most randomised clinical trials is to draw conclusions about the effect of a ...
Posted by Michael Wonder on 23 Aug 2021
FDA approves first COVID-19 vaccine
23 August 2021 - Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. ...
Posted by Michael Wonder on 23 Aug 2021
Axsome Therapeutics provides update on the new drug application for AXS-05 for the treatment of major depressive disorder
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...
Posted by Michael Wonder on 23 Aug 2021
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
20 August 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) for the treatment of active polyarticular ...
Posted by Michael Wonder on 23 Aug 2021
TGA grants provisional determination to Celltrion Healthcare's anti-viral COVID-19 treatment regdanvimab
23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare in relation to regdanvimab. ...
Posted by Michael Wonder on 23 Aug 2021
TGA grants provisional determination to Roche combination COVID-19 treatment casirivimab and imdevimab (Ronapreve)
23 August 2021 - On 20 August 2021 the TGA granted provisional determination to Roche in relation to the combination ...
Posted by Michael Wonder on 23 Aug 2021
ATAGI update following weekly COVID-19 meeting (18 August 2021)
23 August 2021 - ATAGI met on Wednesday 18 August 2021 to review the latest developments relating to COVID-19 and COVID-19 ...
Posted by Michael Wonder on 22 Aug 2021
Accelerated approval - an unexpected pathway to value-based pricing?
18 August 2021 - Accelerated approval is an important regulatory pathway that provides early access to treatments for patients with serious ...
Posted by Michael Wonder on 22 Aug 2021
TGA approves new COVID-19 treatment for use in Australia
20 August 2021 - Australians with COVID-19 who are at risk of hospitalisation will now have access to an additional antibody ...