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China’s Haisco Pharmaceutical continues to wield deals, this time out-licensing rights to two late-stage programs to New Jersey biotech Nuvectis.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.
Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.
Strong science, lower costs and growing capital networks are putting Spain and Portugal on the biotech investment map, even as structural bottlenecks persist, according to two investors.
Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say.
Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.
Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods.
It’s the latest Big Pharma deal for molecular glue technology and Novartis’ second with Orionis Biosciences, after first linking up in March 2020. The backloaded agreement will see Novartis pay $40 million upfront.
In this episode of Denatured, you’ll be hearing from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc as they discuss the rise of Southern Europe’s biotech ecosystem.
Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market will rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices.