Blog
RSS FeedPosted by Michael Wonder on 27 Oct 2022
FDA continues to advance medicines for children
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...
Posted by Michael Wonder on 27 Oct 2022
PMPRB finds ultra-rare drug Procysbi is excessively priced
26 October 2022 - On 1 September 2022, a Panel of the Patented Medicine Prices Review Board issued a decision that ...
Posted by Michael Wonder on 27 Oct 2022
Cheaper medicines legislation passed
27 October 2022 - The Australian Government’s legislation, which will see millions of Australians pay 29% less for scripts with the ...
Posted by Michael Wonder on 26 Oct 2022
Germany significantly tightens drug pricing and reimbursement laws
26 October 2022 - The German regulation of pricing and reimbursement of pharmaceuticals is probably one of the most complicated legal ...
Posted by Michael Wonder on 25 Oct 2022
FDA panel vote highlights accelerated approval concerns
25 October 2022 - Last week’s overwhelming vote in favour of pulling preterm-birth drug Makena from the market — and ...
Posted by Michael Wonder on 22 Oct 2022
US Government is talking to companies about drug price negotiations
21 October 2022 - The US Government is holding talks with health insurers and drug makers as it sets up ...
Posted by Michael Wonder on 21 Oct 2022
PBS minimum stockholding requirements
21 October 2022 - Amendments made by the National Health Amendment Act 2021 give effect to the commitments in the new ...
Posted by Michael Wonder on 20 Oct 2022
Drug makers look to limit Medicare’s new power to negotiate lower drug prices
20 October 2022 - Industry tries to ease impact of Inflation Reduction Act, as regulators start to implement the law. ...
Posted by Michael Wonder on 20 Oct 2022
What the Makena vote means about accelerated approval, trust, and the FDA
19 October 2022 - On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that ...
Posted by Michael Wonder on 20 Oct 2022
How digital health innovators can successfully navigate evolving FDA regulations
19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...
Posted by Michael Wonder on 19 Oct 2022
Advancing real world evidence program
19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...
Posted by Michael Wonder on 18 Oct 2022
IntelGenx submits response to CRL from FDA for Rizaport VersaFilm
18 October 2022 - IntelGenx today announced that it has responded to the complete response letter for its 505(b)(2) new ...
Posted by Michael Wonder on 18 Oct 2022
AvroBio granted ILAP designation from UK MHRA for first in class gene therapy for Gaucher disease
18 October 2022 - ILAP intended to accelerate regulatory review process and facilitate patient access in UK for seriously debilitating and ...
Posted by Michael Wonder on 17 Oct 2022
Calls for TGA to withdraw Covid drug approval
17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...
Posted by Michael Wonder on 17 Oct 2022
FDA pushes to remove pregnancy drug, company pushes back
18 October 2022 - The maker of a drug intended to reduce premature births is making a last-ditch effort to keep ...