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Clinical Trials

Sage Prioritizes Zurzuvae For PPD, Ends MDD Effort, Drops Zulresso

Sage Prioritizes Zurzuvae For PPD, Ends MDD Effort, Drops Zulresso

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.

Zai Lab’s DLL3 ADC Emerges As New Force In ES-SCLC Race

Zai Lab’s DLL3 ADC Emerges As New Force In ES-SCLC Race

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.

Beijing Biostar To Ride HK IPO To Progress Lead Asset In 2L NSCLC

Beijing Biostar To Ride HK IPO To Progress Lead Asset In 2L NSCLC

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.

Gaming Out The Scenarios For Cagrisema And MariTide

Gaming Out The Scenarios For Cagrisema And MariTide

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.

Novo Bares Its SOUL To Uncertain Effect

Novo Bares Its SOUL To Uncertain Effect

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

Double Jeopardy: Brightening The Outlook For Women With Rare Liver Disease

Double Jeopardy: Brightening The Outlook For Women With Rare Liver Disease

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.

Formycon Points To Positive Results For Keytruda Biosimilar

Formycon Points To Positive Results For Keytruda Biosimilar

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.”

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

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.

Animal Testing Alternatives Need Central Office At US FDA, Science Board - Clone

Animal Testing Alternatives Need Central Office At US FDA, Science Board - Clone

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.

Clearer Regulatory Frameworks Needed For Ultra-Rare Conditions, Experts Say

Clearer Regulatory Frameworks Needed For Ultra-Rare Conditions, Experts Say

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.