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Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications

 
• By Sarah Karlin-Smith

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

patent license agreement
The Biden administration will have to review more than 80,000 comments on a proposed rule impacting patent rights • Source: Shutterstock

The brand pharmaceutical industry is asking the US government to tighten manufacturer’s patent rights on brand name drugs, pushing the new US political leadership under President Joe Biden to go even further than a proposed Trump rule, which would make it harder for the government to break patents due to the price of medicines funded with taxpayer resources.

It’s a bold tactic, given that Democrats have long been more open to the idea of using so called “march...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.