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RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Sep 2023
Astellas withdraws lawsuit after evading Medicare drug price negotiations
6 September 2023 - Astellas was so sure that one of its drugs was going to be selected as part ...
Posted by Michael Wonder on 05 Sep 2023
Novartis sues US Government over Medicare drug price regulation
1 September 2023 - Swiss drug maker Novartis on Friday said it had sued the US Government in an attempt ...
Posted by Michael Wonder on 04 Sep 2023
What to expect from the emerging battle royale over drug prices
2 September 2023 - On 29 August, the Biden administration announced the first 10 drugs whose prices will be negotiated with ...
Posted by Michael Wonder on 30 Aug 2023
Medicare should negotiate with drug makers. But not set prices.
30 August 2023 - New rules in America threaten to deter innovation. ...
Posted by Michael Wonder on 30 Aug 2023
Withdrawn accelerated approvals for cancer indications in the US: what is the marketing authorisation status in the EU?
30 August 2023 - As of April, 2023, 23 accelerated approvals for cancer indications granted by the US FDA since 1992 ...
Posted by Michael Wonder on 30 Aug 2023
FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products
30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...
Posted by Michael Wonder on 30 Aug 2023
America’s plan to cut drug prices comes with unpleasant side effects
29 August 2023 - It is already changing how pharma companies make drugs. ...
Posted by Michael Wonder on 29 Aug 2023
HHS selects the first drugs for Medicare drug price negotiation
29 August 2023 - For the first time, Medicare will be able to negotiate prices directly with drug companies, lowering ...
Posted by Michael Wonder on 24 Aug 2023
PMPRB report reveals most new medicines come to market with high treatment costs
22 August 2023 - The Patented Medicine Prices Review Board published today the 7th edition of its annual Meds Entry Watch ...
Posted by Michael Wonder on 22 Aug 2023
Boehringer latest to sue US over drug price negotiation plan
21 August 2023 - Boehringer Ingelheim sued the US Government in an attempt to block a program that gives the ...