Amanda Lanier

1 week ago | bioworld.com | Amanda Lanier

Biopharma clinical updates April 2025Axsome's solriamfetol shows mixed results amid 13 phase III wins in AprilBioWorld recorded 151 clinical trial updates from phases I through III in April 2025, a drop from 197 in March. The month saw 13 successful phase III readouts, alongside four failed trials and two with mixed results. BioWorld Analysis and data insight Clinical

2 weeks ago | bioworld.com | Amanda Lanier

Index insights Chikungunya wins boost Valneva; overall infectious disease stocks fallInfectious disease stocks stumbled in the early months of 2025, with the BioWorld Infectious Disease Index (BIDI) plunging 17.83% by the end of April, well behind the broader markets. By comparison, the Nasdaq Biotechnology Index slipped just 1.16%, and the Dow Jones Industrial Average declined 4.41%. In 2024, the BIDI ended the year down 6.28%, after hitting a low of -25.12% in late April.

2 weeks ago | bioworld.com | Amanda Lanier

Biopharma regulatory actions and approvals April 2025Atzumi and Vanrafia among 3 NMEs approved by US FDA in AprilThe U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022.

2 weeks ago | bioworld.com | Amanda Lanier

Biopharma regulatory actions and approvals April 2025Atzumi and Vanrafia among 3 NMEs approved by US FDA in AprilThe U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022.

3 weeks ago | bioworld.com | Amanda Lanier

Index insights Drug developer stocks fall as companies navigate clinical roadblocksThe BioWorld Drug Developers Index underperformed both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) throughout February and March. However, it showed some recovery by the end of April, finishing the month down 4.67%, slightly worse than the DJIA’s 4.41% decline. The NBI ended April slightly up from both, with a year-to-date drop of 1.16%. BioWorld Analysis and data insight