GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease.

Innovent Biologics has made the case that its checkpoint inhibitor-cytokine fusion protein has a future in colorectal cancer. A phase 1 trial that combined the drug candidate with Avastin reported a 21.9% response rate, including signs of efficacy in patients with liver metastases and prior immunotherapy use.

After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided that a planned advisory committee meeting won’t be required.

Much of the brain is made up of a constellation of star-shaped cells called astrocytes, which play vital roles in immunity, neuron maintenance and many other functions. In Alzheimer’s disease, some astrocytes serve as celestial guardians that break down the amyloid beta protein plaques that build up in the brain; others, however, go rogue, actually secreting amyloid beta themselves.

The FDA is getting the word out regarding a recall effort from Zimmer Biomet related to its discontinued CPT hip implant and its potential link to fractures of the thigh bone after placement.

Though Alkeus Pharmaceuticals’ oral eye disease asset failed to significantly reduce geographic atrophy (GA) lesion growth, the biotech is citing “clinically meaningful” results and a secondary endpoint win as reasons to pursue further development.

Five months after Rakovina Therapeutics pivoted toward artificial intelligence, the cancer-focused biotech has joined forces with Variational AI to identify new therapies against DNA-damage response (DDR) targets.

PharmaLegacy Laboratories is snapping up BTS Research in hopes of expanding its reach as a preclinical CRO.

As it works to diversify its methods for catching early cases of colorectal cancer, Exact Sciences has put forward clinical data showing its blood-based test can help spot growing tumors as well as some precancerous lesions.

Lantheus may have been hoping that “statistically significant” phase 3 data for its radioligand therapy would make a splash at ESMO, but not everyone is impressed.