Finnish biotech Orion has spied potential in Aitia’s “digital twin” tech to develop new cancer drugs.

While Windtree Therapeutics has struggled to grow the financial roots needed to survive, a phase 2 win for the biotech’s lead asset will at least give the company encouragement to persevere.

An attempt by Merck & Co. to unlock the microsatellite stable (MSS) metastatic colorectal cancer market has ended in failure. The drugmaker found a fixed-dose combination of Keytruda and an anti-LAG-3 antibody failed to improve overall survival, extending the wait for a checkpoint inhibitor that moves the needle in the indication.

Health tech company PicnicHealth is launching a new program that lets researchers conduct clinical trials in cyberspace. Virtual Site is meant to help clinical trial sponsors conduct observational studies without the need for a physical location.

Roche is rolling out what it describes as a new type of infectious disease diagnostic in Europe, with a single test capable of screening for up to 12 of the most common respiratory viruses at once.

Recently debuted Metsera is unfolding some phase 1 data for its GLP-1 receptor agonist, revealing a 7.5% reduction in body weight compared to baseline at 36 days.

The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and tracheostomy tubes that enter the airway through the neck. The agency categorized each of them as Class I recalls, its most serious type.

To help clinical trial sponsors who are planning global cancer studies best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in oncology. The draft includes considerations for selecting clinical trial sites, analyzing data and incorporating regional information about the disease and available treatments.

Biohaven has linked troriluzole to a significant slowing of progression in an ultra-rare disease, setting the biotech up to take another shot at winning approval with an asset that the FDA refused to review last year.

AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate (ADC) has again failed to improve overall survival (OS) in a phase 3 trial. The latest miss happened in breast cancer, a setting in which Gilead Sciences’ rival Trodelvy significantly improved OS in a prior late-phase study.