Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2023
Biden Administration’s Medicare drug price negotiations will face major tests in 2024
28 December 2023 - US patients and drug makers will get a first glimpse of how much Medicare can negotiate down ...
Posted by Michael Wonder on 22 Dec 2023
Centralised marketing authorisations of generic versions of Tecfidera are revoked by the European Commission
19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions ...
Posted by Michael Wonder on 19 Dec 2023
Artificial intelligence workplan to guide use of AI in medicines regulation
18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...
Posted by Michael Wonder on 16 Dec 2023
Biden Administration to impose inflation penalties on dozens of drugs
15 December 2023 - The Biden Administration said on Thursday it had identified 48 drugs in the Medicare program whose ...
Posted by Michael Wonder on 15 Dec 2023
CSL Behring’s Hemgenix granted first ever direct access in France for haemophilia B gene therapy
13 December 2023 - CSL Behring has been granted Direct Access for Hemgenix (etranacogene dezaparvovec) by the French Ministry of ...
Posted by Michael Wonder on 14 Dec 2023
Apellis provides update on on-going regulatory review of pegcetacoplan for GA in the European Union
14 December 2023 - Apellis Pharmaceuticals announced today an update on the on-going review of its marketing authorisation application for ...
Posted by Michael Wonder on 14 Dec 2023
MHRA supports launch of Innovate UK’s first of its kind initiative to fund new regulatory science and innovation networks
14 December 2023 - Applications are now open for academic institutions wishing to bid for funding to collaborate with others to ...
Posted by Michael Wonder on 13 Dec 2023
First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
12 December 2023 - The European Commission, the Heads of Medicines Agencies and EMA have published the first version of the ...
Posted by Michael Wonder on 12 Dec 2023
FDA creates new advisory committee for evaluation of genetic metabolic disease treatments
12 December 2023 - Today, the US FDA announced it is creating a new advisory committee related to potential treatments for ...
Posted by Michael Wonder on 08 Dec 2023
Statement from President Joe Biden on FDA approval of gene therapies to treat sickle cell disease
8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...
Posted by Michael Wonder on 08 Dec 2023
US sets policy to seize patents of Government funded drugs if price deemed too high
8 December 2023 - The Biden Administration on Thursday announced it is setting new policy that will allow it to ...
Posted by Michael Wonder on 07 Dec 2023
‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices
7 December 2023 - In 1997, Celgene obtained a key patent for what would become a blockbuster blood cancer treatment, ...
Posted by Michael Wonder on 07 Dec 2023
Biden Administration could seize patents for high priced drugs
7 December 2023 - The Biden administration proposed a rule Thursday that could let the Government seize patents for medicines developed ...
Posted by Michael Wonder on 05 Dec 2023
Relaunched EMA website now live
5 December 2023 - EMA has relaunched its website: www.ema.europa.eu. ...
Posted by Michael Wonder on 05 Dec 2023
Government sends mixed message to global life science investors
5 December 2023 - The Government has published new terms for the Statutory Scheme for branded medicines, maintaining sales rebates ...