At the recent annual meeting of the Muscular Dystrophy Association, Peter Marks, head of the Center for Biologics Evaluation and Research, noted the importance of using the accelerated approval channel for gene therapies: "We can’t be so careful about our approvals under accelerated approval that we prevent potentially lifesaving therapies from getting to market in a timely manner," he said.
read full article ›WOoT! We are very happy to have you on board Denise Wolff!
read full article ›Stop by Booth #110 at Access USA to meet the Real Endpoints team! We're showcasing RE Assist, a tech-enabled platform that simplifies the process of finding copay assistance for Medicare patients.
read full article ›Seems like the biopharma industry, not just Caesar, should beware the ides of March. Yesterday, the Centers for Medicare & Medicaid Services updated its guidance for drug price negotiation under the Inflation Reduction Act clarifying that drugs with the same active ingredients will be groups together even if they are approved under different biologic license applications. That suggests that different formulations (say a sub-cue version of an infusion product developed earlier) would be subject to price negotiation at the earliest date of eligibility.
read full article ›The Real Endpoints team is pleased to sponsor the InformaConnect Access USA meeting in Philadelphia next week. We’re showcasing RE Assist, a tech-enabled platform that simplifies the process of finding copay assistance for Medicare patients.
read full article ›For those mulling the Biden administration's plan to eliminate hepatitis C infection, here's a trip back in time to 2018, to one of the first papers talking about Netflix-style models for drug payment.
read full article ›The three essential components to a successful innovative contract according to Jeff Berkowitz: 1. focus on real and meaningful patient outcomes 2. provide the payer with meaningful value 3. make it simple and easy to execute
read full article ›Rob O'Brien in action at a March 8 Employers Health conference. With payers creating access barriers to many new therapies (specialty meds, here's looking at you), influencing employers' coverage decisions is a top priority for many drug companies. It's a tricky proposition, though.
read full article ›An important topic given the number of drugs that require a diagnostic for use. @Real Endpoints will dive deeper into this topic at BIO in June, just fyi.
read full article ›Consider the most successful drug launches of the past few years. The Covid vaccines, of course. But more interesting: the unexpected success of Tepezza, from Horizon, which is being acquired by Amgen.
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