Amgen and J&J have billions of dollars at stake in the battle to convince CMS to change its coverage proposal for EPO in cancer patients. Win or lose, their efforts will be a valuable case study for any other manufacturer that fi nds itself facing an adverse reimbursement policy.
By Michael McCaughan
"I don’t think there are any rules of the road here." That is how Josh Ofman, Amgen Inc.’s VP-global coverage...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
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.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
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.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
