Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2023
Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.
21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...
Posted by Michael Wonder on 22 Sep 2023
PMPRB report shows increased plan costs, promising pharmaceutical innovation: expert
20 September 2023 - A recent report by the Patented Medicine Prices Review Board shows increased growth for private drug ...
Posted by Michael Wonder on 21 Sep 2023
The Inflation Reduction Act and access to high cost cardiovascular therapies
20 September 2023 - On August 29, 2023, the Biden-Harris administration announced the first 10 drugs selected for Medicare price ...
Posted by Michael Wonder on 21 Sep 2023
Medicare’s historic prescription drug price negotiations
20 September 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs whose prices will be ...
Posted by Michael Wonder on 18 Sep 2023
The problem of limited supply agreements for Medicare price negotiation
15 September 2023 - Pharmaceutical manufacturers charge high prices for their products during periods of market exclusivity that end when ...
Posted by Michael Wonder on 16 Sep 2023
FDA’s final breakthrough devices guidance now includes technologies that address health disparities
15 September 2023 - Final guidance on the US FDA breakthrough device program includes new language noting that the program ...
Posted by Michael Wonder on 15 Sep 2023
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
15 September 2023 - The CHMP has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine ...
Posted by Michael Wonder on 14 Sep 2023
Inflation Reduction Act continues to lower out of pocket prescription drug costs for drugs with price increases above inflation
13 September 2023 - CMS announces savings for some people with Medicare on 34 Part B prescription drugs. ...
Posted by Michael Wonder on 13 Sep 2023
Merck can’t sue over drug pricing plan, HHS tells court
13 September 2023 - Company isn’t primary manufacturer, administration argues. ...
Posted by Michael Wonder on 13 Sep 2023
FDA proposes changes to key approval pathway for medical devices, five years after promising
12 September 2023 - Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, ...
Posted by Michael Wonder on 12 Sep 2023
MHRA’s new International Recognition Procedure: how does it shape up?
12 September 2023 - The field of life sciences and medicine development has become increasingly global. Multinational firms must make informed ...
Posted by Michael Wonder on 12 Sep 2023
The Inflation Reduction Act will lead to fewer new medicines
11 September 2023 - The impact of the Inflation Reduction Act on the biopharmaceutical industry is going to be substantial in ...
Posted by Michael Wonder on 11 Sep 2023
Yale experts discuss impact of Medicare price negotiation legislation
11 September 2023 - Following the announcement of the 10 drugs for which Medicare is authorised to negotiate prices, Yale experts ...
Posted by Michael Wonder on 08 Sep 2023
The 4 arguments you will hear against drug price negotiation
6 September 2023 - While government-negotiated prices will not take effect until 2026, the list of specific drugs makes this legislative ...
Posted by Michael Wonder on 07 Sep 2023
Inflation Reduction Act may accelerate generic and biosimilar market entry, but questions remain around CMS guidance
5 September 2023 - Last week, the Centers for Medicare and Medicaid Services announced its selection of the first 10 prescription ...