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 03 Dec 2021
ATAGI update following weekly COVID-19 meeting (1 December 2021)
3 December 2021 - On 1 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety. ...
Posted by Michael Wonder on 02 Dec 2021
MHRA grants conditional marketing authorisation for COVID-19 treatment Xevudy (sotrovimab)
2 December 2021 - A supply agreement reached with UK government will enable access to sotrovimab for UK patients. ...
Posted by Michael Wonder on 02 Dec 2021
Harmonisation of health technology assessment across the European Union: lessons for the United States
2 December 2021 - In the multi-payer US system, each public program, private insurer, and self-insured employer conducts its own ...
Posted by Michael Wonder on 02 Dec 2021
PHARMAC in review (2021) - part 2
3 December 2021 - As expected, the interim report fails to address the elephant in the room. ...
Posted by Michael Wonder on 02 Dec 2021
Call for a central portal for clinical study reports
1 December 2021 - In an open-access publication in the Journal of European CME, two authors from IQWiG argue that ...
Posted by Michael Wonder on 02 Dec 2021
Investors say drug pricing measure may shift incentives for biotech venture funding
2 December 2021 - Some analysts say bill would discourage investment in drugs taken as pills. ...
Posted by Michael Wonder on 02 Dec 2021
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...
Posted by Michael Wonder on 02 Dec 2021
Strengthening patient access to new medicines through new landmark Bill
2 December 2021 - Australians will see improved access to new and innovative medicines, vaccines and treatments as a landmark ...
Posted by Michael Wonder on 02 Dec 2021
PHARMAC review: 'Damning' interim report reveals 'fortress mentality', Māori, equity progress slow
2 December 2021 - An interim report of a major PHARMAC review has slated the Government drug buying agency over ...
Posted by Michael Wonder on 02 Dec 2021
DoH revises agenda for March 2022 PBAC meeting twice in one day!
2 December 2021 - Version 3 came and went quickly; the current version (version 4) makes no reference to the ...
Posted by Michael Wonder on 02 Dec 2021
PHARMAC welcomes interim report
2 December 2021 - PHARMAC accepts many of the observations made in the Interim Report and is already making changes ...
Posted by Michael Wonder on 02 Dec 2021
CytoDyn submits CMC (manufacturing) section of HIV BLA to FDA under previously authorised rolling review; last (clinical) section will complete full BLA submission
1 December 2021 - FDA may initiate review of this biologics license application under previous rolling review granted to CytoDyn. ...
Posted by Michael Wonder on 02 Dec 2021
COVID-19 vaccine weekly safety report (2 December 2021)
2 December 2021 - To 28 November 2021, the TGA has received 354 reports which have been assessed as likely to ...
Posted by Michael Wonder on 02 Dec 2021
BeyondSpring Pharmaceuticals receives complete response letter from the FDA for plinabulin new drug application for prevention of chemotherapy-induced neutropenia
1 December 2021 - BeyondSpring Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 02 Dec 2021
Pfizer Canada initiates submission to Health Canada for COVID-19 oral anti-viral candidate
1 December 2021 - Pfizer Canada today initiated the filing of a rolling new drug submission with Health Canada for its ...