Gain a Regulatory Edge in Early-Phase Drug Development

SciBase has secured its first positive US medical policy from a major Blue Cross Blue Shield organization: Highmark will cover the company's Nevisense skin lesion assessment for patients being evaluated for possible melanoma.

Alvotech and its partner Advanz Pharma have submitted a European regulatory application for AVT29, a proposed biosimilar to the high-dose retinal disease drug Eylea 8 mg. According to the companies, it is the first known submission of its kind worldwide.

Swedish medtech company NanoEcho has been declared bankrupt after failing to find a solution to its strained financial situation.

A study of Ukrainian combat veterans with limb loss reports 97.9% implant survival one year after completion of treatment with Integrum’s OPRA Implant System, a bone-anchored prosthesis.

Swedish biosimilar developer Xbrane Biopharma has fully recruited the pivotal clinical trial of Xdivane, its biosimilar candidate to Bristol Myers Squibb's cancer immunotherapy Opdivo (nivolumab).

Zealand Pharma has entered a collaboration and license agreement with Generate Biomedicines to develop AI-engineered multispecific protein therapeutics for obesity and other metabolic diseases. Generate is eligible for nearly USD 1.2 billion in milestones for the first two programs.

For bladder cancer patients, the hardest part of treatment is often not knowing whether it will work. At Karolinska Institutet and SciLifeLab, researchers are developing tools that read a tumor's own molecular signals to predict who will benefit from novel systemic therapies – before treatment even begins.