article thumbnail

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

13 Skylar Jeremias, “The IRA’s Unintended Consequences for Drug Pricing and Coverage,” The American Journal of Managed Care , April 2, 2025, [link] www.ajmc.com/view/the-ira-s-unintended-consequences- for-drug-pricing-and-coverage. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025.

article thumbnail

FDA publishes more than 200 archived CRLs for transparency

Pharmaceutical Technology

By GlobalData Learn more about Strategic Intelligence A study conducted by FDA researchers in 2015 found that companies did not publicly acknowledge 85% of safety and efficacy concerns raised by the agency. FDA Commissioner Marty Makary stated: “For far too long, drug developers have been playing a guessing game when navigating the FDA.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

GRIN Therapeutics: Seeking to address unmet needs in rare neurodevelopmental disorders

pharmaphorum

Skip to main content Monday 30 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

article thumbnail

FDA Publishes More Than 200 Complete Response Letters

PharmaTech

A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Unprecedented Move Previously, the FDA had not routinely shared CRLs publicly. Sponsors often disclosed minimal information when announcing a non-approval.

Dosage 52
article thumbnail

Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

article thumbnail

Update: Rumour confirmed as Lilly buys Verve Therapeutics

pharmaphorum

billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.

article thumbnail

8th Neuropsychiatric Drug Development Summit

pharmaphorum

Skip to main content Friday 27 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)