Month: September 2025
Resitu Medical has received FDA 510(k) authorization for the RESL09 breast cancer biopsy device. This handheld minimally invasive device excises tissue samples with diameters up to 9 mm and will first reach market in the US. The company plans to expand the tool’s clinical claims and core size range.
Nanexa has received approval for a Japanese patent covering a specific structure in the shell used in its PharmaShell platform, strengthening the company’s portfolio of intellectual property for long-acting injectables based on atomic layer deposition technology. The patent has been granted under number JP7733651B2 and will run until at least December 2039.
Applications from the same family have been filed in other key regions, including the US and Europe. In recent months, Nanexa has also submitted three further patent applications that cover improvements to its PharmaShell technology, which the company expects will add protection until 2046 if granted.
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Its Phase III data compare favorably with same-class Cosentyx and Bimzelx in hidradenitis suppurativa, and the company is now seeking a partner.
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- Limula and IPC are collaborating to explore LimONE technology for hematopoietic stem cell transplantation applications.
- LimONE aims to improve product quality by automating the removal of cryoprotectants and cellular debris from thawed apheresis samples.
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Beyond Billion-Dollar Bets: How Affibody Might Solve Radioligand Therapy's Greatest Challenges
The radioligand therapy market will be worth $42 billion by 2032. However, beneath the headline-grabbing acquisitions lies a complex web of technical and commercial challenges that threaten to limit patient access to these revolutionary cancer treatments. The path to successful radioligand development is fraught with obstacles, from the "melting ice cube" logistics of short-lived radioisotopes to the renal toxicity pitfalls that plague small-molecule approaches.
In this episode of BioBiz Buzz, your host Mike Ward sits down with David Bejker, CEO of Swedish biotech Affibody, to explore how engineered protein platforms are systematically addressing the industry's most pressing challenges. With over 20 years of radioligand development experience and more than 200 patients dosed, Affibody has developed a unique solution: engineered proteins 25 times smaller than traditional antibodies that deliver targeted radiation with unprecedented precision while avoiding the toxicity issues that have historically limited therapeutic efficacy.
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