16
Oct

2025

GlobalData’s Rob Barrie reports on how Sweden is building one of Europe’s most dynamic biotech ecosystems.

With a legacy rooted in global scientific excellence, Sweden is quietly building one of Europe’s most dynamic biotech ecosystems - despite lacking a big pharma anchor and facing persistent funding gaps.

15
Oct

2025

BD, ten23 health, and Partners to Demo full RFID Syringe Traceability at CPHI Frankfurt
  • CPHI Frankfurt 2025 will highlight advancements in pharmaceutical process control, patient safety, and efficiency, addressing automation, material performance, and regulatory compliance challenges.
  • BENEO's galenIQ™ excipient offers robust granule formation and high-strength tablets for continuous manufacturing, enhancing patient compliance with its pleasant taste.

 

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13
Oct

2025

Cellevate to Announce Major Advances in Yield and Scalability of Viral Vaccine Production at WVC Europe with Global Launch of Cellevat3d® VAX Nanofiber Microcarriers

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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13
Oct

2025

Chris Spivey of PharmExec.com interviews ten23 Health CEO Hanns-Christan Mahler on understanding and managing risk in fill and finish manufacturing

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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08
Oct

2025

PharmNovo Secures CTA Approval in Spain initiating Phase IIa Trial of PN6047 to Treat Neuropathic Pain without Risk of Addiction

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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08
Oct

2025

Shani Alexander hears from AI Medical Technologies CEO Christoffer Ekstrom about how AI is revolutionising skin cancer detection

 

 

07
Oct

2025

Affibody Doses First Patient in Phase I Trial of ABY-271 for HER2+ Metastatic Breast Cancer

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. 

06
Oct

2025

NanoPhoria Announces Largest Ever Italian Series A Biotech Raise for HF Indication

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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02
Oct

2025

AAVantgarde Bio receives ODD and CTA for AAVB-039 to address Stargardt Disease
  • 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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30
Sep

2025

Resitu Medical Receives 510(k) Marketing Authorization from US FDA for its Breast Biopsy Device

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.

Resitu breast tissue biopsy device, RESL09
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