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

 
• By Derrick Gingery, Sarah Karlin-Smith, and Bridget Silverman
  
Generate a summary of this article
Listen to this article
Beta

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 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.

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Review Pathways

PS-Pathways&Standards (Free-1): Industrial Chemicals Within Us - The Ubiquity of Industrial Products in the Human Body

 
• By Nabil

Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .

Brazil Issues Guidance On Regulatory Reliance & Equivalent Authorities

 
• By Francesca Bruce

Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.

Primary Biliary Cholangitis Drug Confirmatory Trials Aim To Avoid Hurdles That Tripped Up Ocaliva

 
• By Sue Sutter

The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
• By Ian Schofield

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

More from Pathways & Standards

Anvisa To Access US FDA-Reviewed Data For More Robust Evaluations In Brazil

 
• By Francesca Bruce

Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.

Califf: Rare Disease Hub Will Develop Methods To Guide Approvability Determinations

 
• By Sarah Karlin-Smith

The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.

Primary Biliary Cholangitis Drug Confirmatory Trials Aim To Avoid Hurdles That Tripped Up Ocaliva

 
• By Sue Sutter

The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.