Blog
RSS FeedPosted by Michael Wonder on 08 Nov 2022
Omeros Corporation receives decision from FDA on formal dispute resolution request for narsoplimab
8 November 2022 - Decision denies Omeros’ appeal requesting immediate labeling discussions. ...
Posted by Michael Wonder on 07 Nov 2022
US Supreme Court to hear Amgen bid to revive cholesterol drug patents
4 November 2022 - The US Supreme Court on Friday agreed to hear Amgen's bid to revive patents on its ...
Posted by Michael Wonder on 07 Nov 2022
New PMPRB guidelines proposed for assessing prices of patented medicines sold in Canada
4 November 2022 - Controversial amendments to the Patented Medicines Regulations changing the basket of comparator countries considered by the ...
Posted by Michael Wonder on 07 Nov 2022
MHRA updates biosimilar guidance to allow interchangeability between products
7 November 2022 - The UK’s MHRA has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if ...
Posted by Michael Wonder on 01 Nov 2022
1 November 2022 updates as part of the digital transformation of Authority Required (Written) PBS listings
1 November 2022 - From 1 November 2022, the PBS listings for certain medicines will be updated as part of the ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted 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 ...