Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2022
Inflation Reduction Act and US drug pricing
8 September 2022 - Landmark US legislation will help millions afford vital treatments. ...
Posted by Michael Wonder on 09 Sep 2022
Bausch Health responds to Norwich Pharmaceuticals tentative FDA approval for a 200 mg rifaximin
9 September 2022 - Bausch Health and its gastro-enterology business Salix Pharmaceuticals today responded to the US FDA's tentative approval ...
Posted by Michael Wonder on 08 Sep 2022
Launch prices: tackling the next drug pricing challenge
8 September 2022 - The passage of the Inflation Reduction Act brings a new era to drug pricing in the ...
Posted by Michael Wonder on 08 Sep 2022
COVID-19 vaccine safety report (8 August 2022)
8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 07 Sep 2022
Statement by President Biden on FDA and CDC authorising updated COVID-19 vaccines
6 September 2022 - This week, we begin a new phase in our COVID-19 response. We are launching a new ...
Posted by Michael Wonder on 07 Sep 2022
CDER and CBER accept first submission to ISTAND pilot program
7 September 2022 - The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have ...
Posted by Michael Wonder on 05 Sep 2022
Clinical trials: real world data plays early role in efforts to increase diversity
5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...
Posted by Michael Wonder on 05 Sep 2022
International work-sharing - first medicines approved by all five Access Consortium regulators
2 September 2022 - The TGA has approved two new medicines as part of the Access New Active-Substance Work-Sharing Initiative. ...
Posted by Michael Wonder on 03 Sep 2022
Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator
3 September 2022 - The adapted COVID-19 vaccine targets both the original virus and the Omicron variant. ...
Posted by Michael Wonder on 02 Sep 2022
FDA still skeptical of ALS drug ahead of high stakes meeting
3 September 2022 - The U.S. FDA has posted another negative review of a closely watched drug for the deadly neurodegenerative ...
Posted by Michael Wonder on 01 Sep 2022
What “negotiating” with Medicare means for drug makers: a mixture of price controls and actual negotiations
1 September 2022 - In the debate on the drug pricing provisions contained in the Inflation Reduction Act, critics call the ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
Posted by Michael Wonder on 30 Aug 2022
Can the Inflation Reduction Act bring down drug prices?
30 August 2022 - The legislation signed by President Joe Biden on August 16 empowers Medicare to negotiate the prices of ...
Posted by Michael Wonder on 30 Aug 2022
Accelerating clinical trials in the EU: publication of 2022-2026 workplan
30 August 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published the 2022-2026 workplan ...