As biosimilars enter the pharmaceutical market, physicians will have to decide whether to prescribe these potentially lower-cost drugs for their patients instead of the originator drug or biologic. In some cases, their own recommendation may not even matter. Physicians, pharmacists, patient advocates, and industry experts spoke of the challenges facing a healthcare system focused on…
Executive Summary Education for investigators and patients about the biosimilar development process, including what’s already known about a product being studied, could help trial recruitment, FDA, industry and patient reps say. Clinical trials comparing proposed biosimilars and their reference products present enrollment challenges that reflect a lack of understanding by clinicians and patients about the…
Executive Summary Following Sandoz’s Zarxio playbook, Pfizer plans to market Inflectra while patent litigation continues; February 2017 trial on cell culture media patent could answer question of potential damages. Celltrion Inc. and partner Pfizer Inc. knocked out one of Janssen Biotech Inc.’s Remicade (infliximab) patents in district court and are betting they will win…
Vice President Joe Biden released a Cancer Moonshot Task Force report Monday morning that lays out a roadmap for the next administration to continue his effort to achieve a decade’s worth of cancer progress in five years. But critics said the moonshot’s lofty goals won’t be met without major new funding that Congress has yet…
The White House’s “moonshot” initiative to transform cancer care taps into industry giants from Microsoft and Amazon Web Services to ridesharing services Uber and Lyft, under a plan released Oct. 17. Vice President Joe Biden presented to President Barack Obama the final report of the cancer moonshot task force—an interagency group forming the federal…
Patient advocates, clinicians, entrepreneurs, and FDA’s top brass deliberated at a congressional briefing here Thursday over how much regulation is needed for lab developed diagnostic tests. Nobody questions the high standards and thorough review drugs undergo before reaching the market, said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. …
Formal FDA review may not be needed for interpreting results of advanced genetic screening tests if the associated databases contain reliable information, the agency’s device chief said. Jeffrey E. Shuren, director of the Center for Devices and Radiological Health, made the remarks while explaining the Food and Drug Administration’s plan to regulate next-generation sequencing…
Cancer seems to touch most Americans, with an estimated 1.6 million diagnosed in 2016, and nearly 40% of Americans diagnosed at some point during their lifetime. That’s why speeding therapies to market is at the heart of the newly organized Oncology Center of Excellence (OCE), an initiative meant to support an integrated approach to evaluating products for cancer…
A conversation with The Cancer Letter and the experts listed below. Jeff Abrams, NCI acting director for clinical research and associate director of the NCI Cancer Therapy Evaluation Program. Abrams wrote his responses with Elad Sharon. Jeff Allen, president and CEO of Friends of Cancer Research, an advocacy organization based in Washington, DC…
Executive Summary In an interview, Margolis Center for Health Policy’s Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI. Mark McClellan, the former FDA commissioner and…
