Blog
RSS FeedPosted by Michael Wonder on 04 Nov 2020
NICE publishes first technology assessment guidance for oesophageal cancer
4 November 2020 - NICE publishes more guidance on the use of nivolumab. ...
Posted by Michael Wonder on 04 Nov 2020
LogicBio Therapeutics receives FDA fast track designation for LB-001 for the treatment of methylmalonic acidemia
4 November 2020 - LogicBio Therapeutics announced today the U.S. FDA has granted fast track designation to its clinical candidate, LB-001 ...
Posted by Michael Wonder on 04 Nov 2020
Pregabalin: supply issue
4 November 2020 - Due to shipping delays, there will be a brief out of stock of Pfizer Pregabalin. ...
Posted by Michael Wonder on 03 Nov 2020
Fury as ‘life-changing’ eczema drug fails to make PBS
3 November 2020 - A “life-changing” drug was supposed to be approved for the Pharmaceutical Benefits Scheme months ago, but eczema ...
Posted by Michael Wonder on 03 Nov 2020
ChemoCentryx and VFMCRP announce European Medicines Agency has accepted to review the marketing authorisation application for avacopan
3 November 2020 - Regulatory submission based on positive data from the pivotal Phase 3 ADVOCATE trial of avacopan. ...
Posted by Michael Wonder on 03 Nov 2020
How people in China with rare diseases afford outrageously expensive medicines?
3 November 2020 - Sky high prices are common for patients with rare diseases. ...
Posted by Michael Wonder on 03 Nov 2020
FDA approves updated label for Endari
3 November 2020 - Emmaus Life Sciences announced today revised prescribing information for Endari to better inform healthcare professionals and sickle ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...
Posted by Michael Wonder on 03 Nov 2020
Getting the price right: how some countries control spending in a fee for service system
2 November 2020 - Although the US has the highest health care prices in the world, the specific mechanisms commonly used ...
Posted by Michael Wonder on 03 Nov 2020
Food and Drug Administration accepts BioMarin's new drug application for vosoritide to treat children with achondroplasia
2 November 2020 - If approved, first therapy in U.S. for the treatment of achondroplasia. ...
Posted by Michael Wonder on 03 Nov 2020
Department publishes revised agenda for November 2020 PBAC meeting
3 November 2020 - One late change ahead of tomorrow's meeting. ...
Posted by Michael Wonder on 03 Nov 2020
Gilead faces pressure to relinquish valuable FDA voucher awarded with remdesivir approval
2 November 2020 - A prominent advocacy group is asking Gilead Sciences to relinquish a valuable voucher that came with ...
Posted by Michael Wonder on 03 Nov 2020
European Medicines Agency validates marketing application for filgotinib for the treatment of ulcerative colitis
2 November 2020 - Application based on results from pivotal Phase 2b/3 SELECTION trial. ...
Posted by Michael Wonder on 03 Nov 2020
PHARMAC funding resources to focus on medicines access equity
3 November 2020 - PHARMAC is pleased to announce the launch of He Ako Hiringa, a clinical education provider with ...
Posted by Michael Wonder on 03 Nov 2020
Provention Bio completes rolling submission of the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
2 November 2020 - Submission of chemistry, manufacturing and controls and administrative information modules represent completion of the Company's submission for ...