Clinical Trials

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.

Ipsen rare diseases head Jennifer Schranz talks to In Vivo about why women are especially susceptible to a “diagnostic odyssey,” and how the company is working to find and treat female zebras.

With clinical trials for its FYB206 proposed biosimilar to Keytruda (pembrolizumab) currently ongoing, Formycon has highlighted analytical studies that suggest its version is “structurally and functionally highly similar to the reference product.”

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

Meeting the regulatory gold standard for drug candidates in ultra-rare diseases can be impractical, a regulatory expert says, but greater collaboration and shared insights from regulatory reviews could help find a viable path forward.