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.
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At AAIC, researchers presented studies using CRISPR-Cas9 in animal/organoid models of Alzheimer’s disease, but some experts doubt that such approaches will successfully translate to humans.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.
With a potential $509 billion up for grabs by 2028, companies including Biogen, Sage, Karuna Therapeutics and Cerevel Therapeutics are vying to bring their drugs across the regulatory finish line.
The companies partnered to develop the antibody transport vehicle in late 2021, but will continue their 2018 agreement to pursue other drugs in preclinical development.
Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.
The vaccine maker cut 25% of staff amid post-pandemic business challenges in May, but resurgent sales and an updated COVID-19 shot may prove a turning point.
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
The Danish company’s vaccine candidate met all co-primary endpoints in a late-stage study in adults and adolescents just months after publishing trial data for elderly patients, as it seeks to challenge Valneva.