Category: Uncategorized
Welcome to the BioPharm International® weekly news roundup for the week of Oct. 13, 2025. In this video feature, the editors highlight each week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.
Biologics, obesity R&D partnerships, and China collaborations are driving pharmaceutical M&A and selective venture capital funding in the third quarter of 2025, according to a new report by J.P. Morgan.
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This series, “The Situation We Faced,” is a CEO-type investigation interview into decision making, set within the context of other options, relative risk-reward situation, outcome and corporate culture ramifications, and market competitiveness positioning. So, sort of a war story reminiscence, but with clear technology or product context, some speculation about how other choices might have assisted or held things back.
As Hanns-Christian Mahler, CEO of Ten23 Health, explains the situation, “We saw up to 80% of the batch that had to be sorted out because of particulate defects in the final product, which eventually were clearly traceable to the primary packaging that was in use….
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STOCKHOLM, SWEDEN – October 9, 2025. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company PharmNovo has received approval from the Spanish regulatory authorities to initiate a phase 2a clinical trial of its drug candidate, PN6047, being developed as a treatment for neuropathic pain. The trial will be conducted in the EU, but has been fully aligned with the requirements defined by the U.S. Food and Drug Administration (FDA), earlier this year.
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The first patient has been dosed in a Phase I clinical trial of breast cancer treatment ABY-271.
ABY-271 is a radiotherapeutic candidate being assessed as a potential treatment for HER2-positive metastatic breast cancer. The Phase I study evaluating the safety, tolerability and biodistribution of ABY-271 is a first-in-human open-label, two-stage, randomised trial being conducted in Sweden and Germany. The first patient was enrolled at Uppsala University Hospital in Sweden.
ABY-271 is an Affibody molecule that targets HER2-expressing tumours and is labelled with the radioisotope lutetium-177, which emits cytotoxic beta radiation, exerting irreversible damage to the tumour cells upon binding.
Italy-based biotech company NanoPhoria Bioscience has announced the initial closing of its Series A funding round, raising €83.5m ($98m).
The round was led by XGEN Venture, Sofinnova Partners and CDP Venture Capital. Panakès Partners and an undisclosed investor also participated.
NanoPhoria will use the funds to advance the development of its lead candidate, NP-MP1, aimed at treating heart failure with reduced ejection fraction (HFrEF). The proceeds will be utilised for investigational new drug (IND)-enabling trials and early clinical development of NP-MP1.
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- AAVB-039 addresses the root cause of the disease, benefitting patients with any ABCA4 mutation
- AAVB-039 is currently being assessed in the CELESTE interventional clinical trial and we continue recruiting in our STELLA observational study
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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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