Content type

GDUFA Fees For 2024 Set To Increase, Compounding Pricing Pressures Faced By Generic Manufacturers In The US

Pharmaceuticals / United States / Thu 24 Aug, 2023

Key View

  • GDUFA fees for FY24 released by the FDA see increases across the board for all fees, with inflation contributing to the increased amounts.
  • This follows a previous trend over the last two years of steadily increasing fees, which we expect will continue into the medium term.
  • Increased GDUFA fees for generic manufactures will compound
Read More

Roche And Exelixis Combination Therapy Shows Promise In Prostate Cancer Following Setbacks In Other Indications

Pharmaceuticals / United States / Tue 22 Aug, 2023

Key View

  • Late-stage success for Roche and Exelixis in prostate cancer show promise of the companies’ combination therapy.
  • The positive results are a boon for the combination following multiple recent clinical failures.
  • Rising global disease incidence highlights need for broader treatment options for prostate cancer patients.

Late-stage

Read More

Viatris And Kindeva's Breyna Launch Provides First Generic Competition For AstraZeneca's Blockbuster Symbicort

Pharmaceuticals / United States / Thu 17 Aug, 2023

Key View

  • The launch of Viatris and Kindeva Drug Delivery's first-to-market generic version of blockbuster Symbicort, known as Breyna, will improve access to asthma and COPD treatment.
  • Following years of legal hurdles, we expect the launch of Breyna will begin to negatively impact Symbicort's sales from 2023, leading developer AstraZeneca to
Read More
Download Indicator Summary
 

Thank you. Your download link will be emailed to you shortly.

Download Now
 

Thank you. Your download link will be emailed to you shortly.

Download Now
 

Thank you. Your download link will be emailed to you shortly.

Clearbit Form
 

Thank you. Your download link will be emailed to you shortly.