Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2021
FDA, sponsors advance reliance on real world data & evidence
2 October 2021 - Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional ...
Posted by Michael Wonder on 02 Oct 2021
The U.S. can lower drug prices without sacrificing innovation
1 October 2021 - Legislation giving Medicare the ability to negotiate drug prices in the United States would make their ...
Posted by Michael Wonder on 30 Sep 2021
U.S. House panel approves fourth bill aimed at drug prices
30 September 2021 - The U.S. House Judiciary Committee voted Thursday to approve a fourth bill aimed at tackling high ...
Posted by Michael Wonder on 30 Sep 2021
Medicines industry continues to protect Australians from medicine shortages
30 September 2021 - ACCC extends approval for ongoing collaboration ...
Posted by Michael Wonder on 29 Sep 2021
Data protection scheme for assessed listed medicines
29 September 2021 - The TGA has implemented a data protection scheme for assessed listed medicines. ...
Posted by Michael Wonder on 28 Sep 2021
Big business lobbies bitterly divided over drug pricing reform
28 September 2021 - Groups representing companies like Apple, Tesla, and Boeing are clashing with Washington’s wealthiest business lobby over ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 23 Sep 2021
Canada should negotiate a fairer share of drug R&D costs
23 September 2021 - Instead of relying on price regulation, Canada should engage in negotiations about drug pricing. ...
Posted by Michael Wonder on 22 Sep 2021
Pfizer CEO rallies staff to fight Democrats' drug price negotiation
22 September 2021 - He added that the company would share methods to raise awareness on the issue in the ...
Posted by Michael Wonder on 22 Sep 2021
TGA approves Leqvio
22 September 2021 - Inclisiran is a cholesterol lowering double-stranded small interfering ribonucleic acid. ...
Posted by Michael Wonder on 21 Sep 2021
U.S. Food and Drug Administration reasoning in approval decisions when efficacy evidence is borderline (2013–2018)
21 September 2021 - The U.S. FDA has substantial flexibility in its approval criteria in the context of life-threatening disease and ...
Posted by Michael Wonder on 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes. ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 16 Sep 2021
Drug makers see disaster in Medicare negotiating prices. Don’t listen to them.
16 September 2021 - The pharmaceutical industry, bizarrely, told the American people this week that allowing Medicare to negotiate drug ...