Pink Sheet Podcast: August User Fee Goals, Oncology Trial Design Issues, EMA Review Changes

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August, a trial design issue that could ensnare BMS’ Opdivo along with AstraZeneca’s Imfinzi, and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews.

Pink Sheet podcast
Could EMA requiring raw clinical data for application reviews boost global harmonization efforts? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Managing Editor Bridget Silverman discuss the bolus of applications that could receive US Food and Drug Administration action this month (:34), US Food and Drug Administration efforts to push oncology sponsors to change their trial design plans and how they could impact a proposed new indication for Bristol Myers Squibb Company’s Opdivo (nivolumab) and AstraZeneca PLC’s Imfinzi (durvalumab) (10:11), and the potential implications of the European Medicines Agency pilot program requiring sponsors to provide raw clinical data with applications for review (33:14).

Open Media

More On These Topics From The Pink Sheet

This and other podcasts are available on the Pink Sheetpodcast page, as well as the Citeline channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

More from Review Pathways

Korea Pre-Review Consultations Help Accelerate R&D

 
• By 

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

More from Pathways & Standards

England’s NHS Plan Eyes Cancer Vaccine Boost, Single Formulary & ‘Pay For Impact’ Drug Deal

 

The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.