No Let Up In Downward Pressure On EU Drug Prices
Maarten Meulenbelt of law firm Sidley Austin explains the pricing challenges that face pharmaceutical companies in Europe during the remainder of 2022 and how they may have to adjust their strategies in order to succeed.
You may also be interested in...
Regulators Keep Rare Diseases Open For Business
The cost of rare diseases to patients and society at large is 10 times higher than for many of the biggest mass market diseases combined. With 95% of rare diseases lacking a treatment or cure, there is an economic imperative for policymakers to keep encouraging pharmaceutical companies to develop more orphan drug treatments. In Vivo looks at the US and EU regulatory impetus to keep rare diseases open for innovation.
Pediatric Study Timelines Could Change Under Senate PDUFA Bill
Provisions aimed at earlier planning and completion of pediatric studies are part of user fee legislative package Senate committee will vote on May 10; measure also calls for FDA guidance on pediatric studies of molecularly targeted cancer drugs but does not require such trials.
Pediatric Study Requirements For Cancer Have FDA Support, But Pose Industry Challenges
Biosimilars could face new requirements if RACE for Children Act expands PREA to molecularly targeted cancer drugs approved for adult indications; other stakeholders also worry about general feasibility.