Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 14 Apr 2022
Alpelisib for patients with advanced hormone receptor positive, HER2 negative, PIK3CA mutated breast cancer
7 April 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 14 Apr 2022
COVID-19 vaccine weekly safety report (14 April 2022)
14 April 2022 - To 10 April 2022, the TGA has received 528 reports which have been assessed as likely to ...
Posted by Michael Wonder on 14 Apr 2022
Public summary documents – December 2021 PBAC meeting (first time decisions not to recommend, deferrals and other matters)
14 April 2022 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the December ...
Posted by Michael Wonder on 13 Apr 2022
Europe’s new HTA system spurs more debate, concern
12 April 2022 - Fresh round of discussions around health technology assessment. ...
Posted by Michael Wonder on 13 Apr 2022
Irish cancer patients wait four months longer for access to new drugs than rest of Europe
11 April 2022 - Cancer patients in Ireland are waiting on average four months longer than people with the disease ...
Posted by Michael Wonder on 13 Apr 2022
Amneal achieves second U.S. biosimilars approval with Alymsys (bevacizumab-maly)
13 April 2022 - Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022. ...
Posted by Michael Wonder on 13 Apr 2022
Insulin isn't affordable for many Americans. That may be a human rights abuse, report says.
13 April 2022 - The cost of insulin has sparked Congressional hearings and calls for change from diabetics and patient advocates. ...
Posted by Michael Wonder on 13 Apr 2022
Paxlovid ‘inaccessible’ to many patients in Canada. Here’s why that needs to change.
13 April 2022 - A pill to treat COVID-19 appears to be the country’s best hope, outside of vaccines and ...
Posted by Michael Wonder on 13 Apr 2022
NICE backs Biogen’s Vumerity for multiple sclerosis
13 April 2022 - Patients with relapsing-remitting multiple sclerosis in England, Wales and Northern Ireland can now access treatment with ...
Posted by Michael Wonder on 13 Apr 2022
Why the drug pricing debate is focused on insulin
13 April 2022 - The treatment has been around for over a century but insulin has still become the centre ...
Posted by Michael Wonder on 13 Apr 2022
Committee releases report uncovering significant conflicts of interest at McKinsey related to work for FDA and opioid manufacturers
13 April 2022 - Chairwoman Maloney calls on McKinsey’s global managing partner to testify at public hearing. ...
Posted by Michael Wonder on 13 Apr 2022
FDA takes important steps to increase racial and ethnic diversity in clinical trials
13 April 2022 - Agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s cancer moonshot goal ...
Posted by Michael Wonder on 13 Apr 2022
Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain
13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...
Posted by Michael Wonder on 13 Apr 2022
European Commission approves Padcev (enfortumab vedotin) for locally advanced or metastatic urothelial cancer
13 April 2022 - Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior ...