The America First Policy Institute has blamed patent abuse for drug unaffordability, poking holes in governmental institutions and their current systems.
In the run-up to the US presidential election, which is set to happen in November 2024, the right-wing non-profit America First Policy Institute has pointed to patent and drug approval systems as one of the reasons for drug unaffordability in the country.
While AFPI refers to itself as a non-partisan organization, the group was launched by alumni of former president Donald Trump’s...
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Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
Shortly after filing its lead candidate for ADHD through the FDA’s 505(b)(2) hybrid new drug application pathway, Cingulate has appointed interim leadership after placing chairman and CEO Shane Schaffer on administrative leave over legal matters unrelated to the company.
Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.
Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.
