Blog
RSS FeedPosted by Michael Wonder on 21 Dec 2022
Classifying ageing as a disease could speed FDA drug approvals
21 December 2022 - The FDA considers ageing to be a natural process. This makes it difficult to get FDA approval ...
Posted by Michael Wonder on 20 Dec 2022
Drug pricing reform in the Inflation Reduction Act: what are the implications? Part 2
15 December 2022 - The Inflation Reduction Act, signed by President Biden on 16 August 2022 is the most substantial drug ...
Posted by Michael Wonder on 19 Dec 2022
Drug pricing reform in the Inflation Reduction Act: what are the implications? Part 1
14 December 2022 - The Inflation Reduction Act, signed by President Biden on 16 August 2022, is the most substantial drug ...
Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 19 Dec 2022
Facilitating decentralised clinical trials in the EU
19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...
Posted by Michael Wonder on 18 Dec 2022
Ardelyx provides update on FDA appeal for Xphozah (tenapanor) for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis
16 December 2022 - Ardelyx provided an update regarding the appeal to the complete response letter for the new drug ...
Posted by Michael Wonder on 11 Dec 2022
The FDA struggle to withdraw Makena; problems with the accelerated approval process
8 December 2022 - Hydroxyprogesterone caproate (Makena) is an injectable drug for the prevention of preterm birth, ie, birth prior to ...
Posted by Michael Wonder on 10 Dec 2022
Pre-approval promises to voluntarily withdraw FDA approved drugs
9 December 2022 - The US FDA faces a persistent tension between confidence and speed. ...
Posted by Michael Wonder on 10 Dec 2022
You're cured till you're not: should disease-free survival be used as a regulatory or clinical endpoint for adjuvant therapy of cancer?
9 December 2022 - Recent commentary reviewing the use of biologics or other novel molecules tested in the adjuvant setting for ...
Posted by Michael Wonder on 04 Dec 2022
Statistical approaches to establishing bioequivalence
2 December 2022 - Requirements for submitting bioavailability and bioequivalence data in investigational new drugs, new drug applications, abbreviated new drug ...
Posted by Michael Wonder on 01 Dec 2022
Aurinia announces the Great Britain marketing authorisation of Lupkynis (voclosporin) for the treatment of lupus nephritis
30 November 2022 - MHRA Approval follows European Commission marketing authorisation of Lupkynis to treat adults with active lupus nephritis in ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 29 Nov 2022
FDA looks to modelling and simulation tools to streamline product reviews
28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...
Posted by Michael Wonder on 28 Nov 2022
Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer
28 November 2022 - The treatment will be made available immediately through an early access deal with NHS England. ...
Posted by Michael Wonder on 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...