Drug Development
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.
FEATURED STORIES
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
In a Phase I trial, Caribou’s allogeneic CAR-T cell therapy candidate induced high rates of treatment response in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
After beginning July with a splash in the Alzheimer’s space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
Data from the OCARINA II trial shows that a 10-minute subcutaneous injection of Ocrevus achieves similar pharmacokinetics as the typical hours-long intravenous infusion in multiple sclerosis patients.
The FDA recently approved the first cellular therapy for Type 1 diabetes and others may not be far behind. But experts say challenges still exist to the widespread application of these treatments.
The company’s ruxolitinib cream Opzelura led to higher rates of treatment success in children with atopic dermatitis than with a control cream.
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.
After paying $300 million upfront to BeiGene for option rights to ociperlimab in December 2021, Novartis has dropped the agreement and given the rights back to the Chinese biotech.
Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.