Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2022
European Union regulation of health technology assessment: what is required for it to succeed?
22 July 2022 - After considerable discussion and debate, the European Commission proposal for the regulation of health technology assessment was ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 22 Jul 2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making
20 July 2022 - EMA has endorsed a joint statement calling for international collaboration to enable the generation and use ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 20 Jul 2022
FDA announces an Oncologic Drugs Advisory Committee meeting to discuss benefit/risk profile of Oncopeptides' Pepaxto
20 July 2022 - Oncopeptides today announces that the US FDA, has announced a forthcoming public advisory meeting of the ...
Posted by Michael Wonder on 20 Jul 2022
Easier access to locally applied HRT to treat post-menopausal vaginal symptoms in landmark MHRA reclassification
20 July 2022 - From September women in the UK will be able to access Gina 10 microgram vaginal tablets without ...
Posted by Michael Wonder on 18 Jul 2022
Aussies could get omicron targeted jab earlier than most
18 July 2022 - Australia could become one of the first countries in the world to administer an omicron-specific vaccine, ...
Posted by Michael Wonder on 17 Jul 2022
'Government excessively controls drug prices, not recognising novel drugs' value'
15 July 2022 - The Government is wielding excessive power to lower drug prices without recognising the values of innovative ...
Posted by Michael Wonder on 12 Jul 2022
Iterum Therapeutics announces special protocol assessment agreement with the FDA
11 July 2022 - SPA supports protocol for Phase 3 clinical trial of oral sulopenem for the treatment of uncomplicated urinary ...
Posted by Michael Wonder on 12 Jul 2022
FDA rule would facilitate prescription to OTC switches but nix a third class of drugs
12 July 2022 - After a decade long wait, the FDA finally issued a proposed rule in late June that ...
Posted by Michael Wonder on 11 Jul 2022
Governor Ron de Santis takes additional actions to lower prescription drug prices for Floridians
8 July 2022 - Today, Governor Ron DeSantis issued Executive Order 22-164 to drive transparency in prescription costs for Floridians. This ...
Posted by Michael Wonder on 10 Jul 2022
SIGA Technologies receives approval from UK for tecovirimat
8 July 2022 - Treatment approved for smallpox, monkeypox, cowpox and vaccinia complications. ...
Posted by Michael Wonder on 10 Jul 2022
Human genetics evidence supports two-thirds of the 2021 FDA approved drugs
8 July 2022 - In 2021, 50 drugs were approved by the FDA’s Center for Drug Evaluation and Research, continuing a ...
Posted by Michael Wonder on 07 Jul 2022
Accelerated approval - taking the FDA’s concerns seriously
6 July 2022 - User-fee re-authorisation creates new opportunities for the FDA to address issues with its accelerated-approval program, including the ...
Posted by Michael Wonder on 06 Jul 2022
Democratic drug pricing bill removes insulin cost cap amid bipartisan push
6 July 2022 - Senate Democrats’ latest bill to lower prescription drug prices removes a provision to cap patients’ insulin ...