As regulators, pharma, and researchers search for more predictive tools, Emulate, Inc’s CEO, Jim Corbett, argues that Organ-on-a-Chip technology is still early. “If this were a nine-inning baseball game, we’re in the first inning - but the direction is very clear.”
✨ Onyx Summary Autolus Therapeutics plc will evaluate the feasibility of Cellares Corp’ automated Cell Shuttle platform to potentially augment future commercial manufacturing capacity for its approved CAR T therapy AUCATZYL at its UK facility. The assessment reflects Autolus’ preparation for potential demand growth beyond current infrastructure and highlights industry efforts
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
“We’re really on the precipice of moving the company into that next stage of maturity,” Dr. Mike Exton
Driven by the precision of viral biology, 4D Molecular Therapeutics is redefining gene therapy’s reach - scaling a once ultra-rare field into broad, sustainable markets.
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
“Over the past year, we have made tremendous progress…” Rick Modi says, as Affinia Therapeutics pushes its BAG3-DCM program toward first-in-human testing, aiming to prove that next-generation capsids can restore heart function at dramatically lower doses.
“We can regulate any gene, anywhere,” says CEO Dr. Amber Salzman, whose Epicrispr team is pioneering epigenetic editing - a precise, non-cutting approach - to transform neuromuscular disease treatment through durable, targeted control of gene activity.
With a median progression-free survival nearing four years in ROS1 lung cancer, Nuvation Bio’s breakthrough therapy signals a turning point for precision oncology - validating Dr. David Hung’s patient-first vision.
September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.
Backed by $70 million in Series A funding, Excellergy emerges from stealth with a mission to lead a new era in immunology - targeting the full IgE pathway to redefine how allergic diseases are treated.
“Fifteen to twenty years ago, a woman under 35 had a 20% chance of live birth per IVF cycle. At Kindbody, today, it’s greater than 50%,” David Stern credits lab innovation and AI for rewriting fertility’s odds.
“After just one single infusion, about a third of patients remained in remission for five years. Some physicians even called it a functional cure,” Ying Huang underlines why CARVYKTI is reshaping expectations in oncology.
“Preventative care spending fell from 14.1% to just 5.2% of Government healthcare spending.” Ben Phillips warns that welfare reforms could widen existing health gaps.
Anis Fahandej-Sadi breaks down the big problems with current incentive structures
