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RSS FeedPosted by Michael Wonder on 04 Oct 2022
Eli Lilly receives marketing authorisation for baricitinib
4 October 2022 - Eli Lilly has announced that the MHRA has granted marketing authorisation for baricitinib – also known ...
Posted by Michael Wonder on 04 Oct 2022
2022 October price disclosure cycle – confirmed prices and patient savings reports
1 October 2022 - Combination flow-on reduction outcomes reflect confirmed 1 October 2022 prices on the Current Price Disclosure cycle web ...
Posted by Michael Wonder on 30 Sep 2022
Medicare lays out the bureaucracy it will need to negotiate drug prices
29 September 2022 - New documents outline how Medicare is planning to build out a sizeable new bureaucratic infrastructure to ...
Posted by Michael Wonder on 29 Sep 2022
MHRA appoints first new UK approved body to certify medical devices since Brexit
29 September 2022 - DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies. ...
Posted by Michael Wonder on 28 Sep 2022
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...
Posted by Michael Wonder on 21 Sep 2022
The Inflation Reduction Act aims to lower drug costs — but here’s how big pharma could get around it
21 September 2022 - The tactics may ultimately threaten the law’s ability to lower drug costs for many in the US. ...
Posted by Michael Wonder on 20 Sep 2022
UK regulator OKs Celltrion's Avastin biosimilar
19 September 2022 - Celltrion said that the UK's MHRA has approved Vegzelma, a biosimilar referencing Avastin (bevacizumab), to treat ...
Posted by Michael Wonder on 19 Sep 2022
Biosimilar medicines can be interchanged
19 September 2022 - EMA and the Heads of Medicines Agencies have issued a joint statement confirming that biosimilar medicines ...
Posted by Michael Wonder on 17 Sep 2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
16 September 2022 - The EMA’s CHMP has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s ...
Posted by Michael Wonder on 17 Sep 2022
Take whatever COVID booster you can get, says head of EU drugs watchdog
14 September 2022 - People in Europe should take whatever COVID-19 booster is available to them in the coming months, ...
Posted by Michael Wonder on 15 Sep 2022
FDA issues final rule on ‘right to try’ reporting requirements
14 September 2022 - Drug firms that agree to supply investigational medicines under the Right to Try Act must submit ...
Posted by Michael Wonder on 15 Sep 2022
FDA’s drug industry fees fuel concerns over influence
15 September 2022 - The pharmaceutical industry finances about 75% of the agency’s drug division, through a controversial program that ...
Posted by Michael Wonder on 14 Sep 2022
Is drug price negotiation a concept whose time has come?
14 September 2022 - The US Congress has just approved the Inflation Reduction Act of 2022, which includes a provision ...
Posted by Michael Wonder on 13 Sep 2022
Explainer: how the US drug pricing law affects Medicare and its members
13 September 2022 - U.S. President Joe Biden last month signed the $430 billion Inflation Reduction Act, authorising the federal ...
Posted by Michael Wonder on 13 Sep 2022
FDA finalises guidance on submitting RWD/RWE in application cover letters
13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...