Clinical Trials

China has proposed new guidelines designed to head off potential bribery by pharma companies related to the conduct of clinical studies and possible manipulation of outcomes.

The Health Research Authority says its new toolkit explains the differences and similarities in the research approval and set-up processes across the four UK nations so that researchers and sponsors are clear on what they need to do if they want to conduct a study in more than one of the countries.

Buoyed by the success of its long-acting risperidone injectable, Teva is continuing to feel upbeat about the potential for its olanzapine LAI candidate, ahead of a full study safety readout anticipated in the first half of 2025.

Q3 sales of DMD gene therapy Elevidys beat forecasts, but the company declined to raise Q4 and 2025 guidance. It plans to file a second gene therapy with the US FDA next year.

Q3 revenue beat consensus and Vertex raised its guidance, but R&D progress was the main highlight across the cystic fibrosis, kidney disease, type 1 diabetes and, particularly, pain pipeline.

As Sage prioritizes Zurzuvae for postpartum depression after recent setbacks, it will stop selling Zulresso for PPD and no longer pursue Zurzuvae in major depressive disorder.

ZL-1310, a DLL3-targeting ADC, has shown a 74% objective response rate in extensive-stage small cell lung cancer after platinum-based chemotherapy, making it a new contender in this setting.

Biostar plans to raise up to $41m through a Hong Kong IPO, which help the Chinese chemotherapy specialist progress lead asset utidelone for various oncology indications.

Two of 2030’s forecast blockbuster obesity drugs are facing binary readouts by the end of the year. Here’s what that could mean for their developers, Novo Nordisk and Amgen.

A mild benefit in the CV outcomes trial of Rybelsus means a likely label expansion in diabetes patients, but probably not vastly increased sales.