NLS Biotech News

Acquisition – September 29, 2025

Genmab to acquire Merus

The two companies have entered into a transaction agreement pursuant to which Genmab intends to acquire all the shares of Merus for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion.

From discovery to delivery: Inside WuXi AppTec’s global CRDMO model

Every drug can be made and every disease can be treated. That’s the vision of WuXi AppTec, the contract research, development and manufacturing organization (CRDMO) that helps accelerate timelines to bring breakthrough treatments to the patients who need them most.

Biotech Business – November 3, 2025

Alvotech provides disappointing update on US BLA for AVT05

The FDA has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi (golimumab).

Cold Chain Failures Cost $35 billion Annually – why is this acceptable?

Every year, the life science industry loses an estimated $35 billion due to failures in cold chain logistics. In a field that rightly demands absolute precision in research, trials, and regulatory compliance, this figure is baffling. How can an industry that accepts no margin of error in the research stage tolerate such staggering and preventable losses once products leave the production site?

Agreement – October 23, 2025

Medivir enters licensing agreement with Biossil

Medivir has entered into an exclusive licensing agreement, through which Biossil, Inc. will receive global, exclusive development rights for remetinostat, a clinical-stage topical HDAC inhibitor.

Clinical trials

Clinical Trials – November 4, 2025

ScandiBio initiates Phase 3 trial: Mini-interview with Mathias Uhlén

The multicentre, phase 3 human clinical trial will evaluate the efficacy and safety of the company’s pharmaceutical, Combined Metabolic Activator, in patients with Alzheimer’s disease.

Clinical Trials – October 22, 2025

ACORAI presents positive results

The company has announced results from the 1,600-patient CAPTURE-HF study (Machine-Learning Estimation of Pulmonary Capillary Wedge and Right Atrial Pressures With a Non-Invasive Multi-sensor Device).

Biotech Business – October 22, 2025

Abera reports long-term data for its nasal influenza vaccine

The results show that the vaccine generates strong and long-lasting immune responses both at the mucosal surfaces and systemically.

Clinical Trials – October 20, 2025

Aqilion announces new clinical pharmacokinetic study results

The company has announced positive results from the ARIA-2 clinical study.

Clinical Trials – October 10, 2025

Herantis announces positive data for HER-096 in Phase 1b trial

Herantis Pharma has announced positive topline results from its Phase 1b trial of HER-096 in people living with Parkinson’s disease, with all primary and secondary endpoints met.

Clinical Trials – October 8, 2025

PharmNovo secures CTA approval in Spain

The company’s clinical trial application (CTA) for a Phase IIa proof of concept (PoC) study investigating the safety and efficacy of lead candidate PN6047 in patients with neuropathic pain has been approved in Spain.

Clinical Trials – October 1, 2025

Gesynta Pharma receives UK approval for a Phase 2 trial

The company’s clinical trial application for the company’s Phase 2 trial of vipoglanstat for the treatment of endometriosis has been approved by the UK authorities.

Clinical Trials – September 25, 2025

Hansa Biopharma’s imlifidase meets primary endpoint in Phase 3 trial

The company has announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm.

Clinical Trials – September 24, 2025

New study aims to provide more cancer patients with targeted treatment

The new, national study uses genetic analysis of tumors to match cancer patients with targeted drugs – even when these are not yet approved for their specific diagnosis.

Clinical Trials – September 17, 2025

AnaCardio completes target enrollment in Phase 2a study

AnaCardio has announced that its ongoing Phase 2a study of AC01 in patients with heart failure and reduced ejection fraction (HFrEF) is fully enrolled and remains on track to report results by year-end 2025.

Profiles in Biotech

Profiles in Biotech – April 23, 2024

Mia Phillipson: Pioneering immunotherapies

Despite being the co-founder of Ilya Pharma and co-director at the Science for Life Laboratory (SciLifeLab), Dr. Mia Phillipson, considers herself a scientist foremost, not an entrepreneur.

Profiles in Biotech – November 28, 2023

Kristian Tryggvason: Reshaping the cell therapy sector

The previous founder and CEO of BioLamina has gone back to business development, and with his newly founded company he aims to redefine cell therapy development even further.

Profiles in Biotech – July 28, 2021

Mathias Uhlén: Driven by curiosity and courage

Being a scientist or an entrepreneur is hard enough. Doing both at the same time sounds like an Olympic sport.

Profiles in Biotech – March 8, 2021

Sara Mangsbo – Scientist and entrepreneur

An academic and an entrepreneur, Dr. Sara Mangsbo, PhD, has found a way to integrate her skills and interests so that they complement and augment her passions.

Profiles in Biotech – January 7, 2021

Evelina Vågesjö: ”I want to see my work go beyond the lab”

What began as a project for Evelina Vågesjö’s doctoral thesis grew into groundbreaking drug candidates and delivery methods, followed not long afterwards, by a clinical-stage biopharmaceutical company.

Profiles in Biotech – October 8, 2020

Robert Langer: Making a difference in medicine

Massachusetts Institute of Technology (MIT) in the US has produced more than its share of engineers and computer scientists, but unlike many of his peers, alumnus Dr. Robert Langer, ScD, turned his chemical engineering skills to medicine, becoming one of the world’s leaders in perfecting effective drug delivery systems.

Profiles in Biotech – June 13, 2018

Britt Meelby Jensen: Accelerating Danish biotech business

She has been called the Danish biotech queen and she is not afraid of responsibility in her role as CEO. On the contrary, Britt Meelby Jensen enjoys leading, setting ambitious goals and accelerating company growth.

Profiles in Biotech – October 6, 2017

Next-generation biotech entrepreneurs

For young scientists and engineers, a startup can be part of early training and education.

Profiles in Biotech – December 16, 2016

Agnete Fredriksen: “You really need to have drive to make it work”

Academia and business don’t always mix, but Agnete B. Fredriksen of Norway has found the formula.

More biotech stories

Biotech Business - November 6, 2025

AAX Biotech and ToxoTech to advance next-generation biotherapeutics for neurological disorders

The two companies have announced a strategic collaboration to advance next-generation biotherapeutics, they state.

Biotech Business - November 5, 2025

Neogap launches collaboration with Weill Cornell Medicine

Neogap Therapeutics has been awarded a SEK 1 million grant from Vinnova to initiate a collaborative project with Weill Cornell Medicine in New York, US.

Agreement - October 24, 2025

AAX Biotech enters collaboration with Daiichi Sankyo

The collaboration marks a significant milestone for AAX Biotech, underscoring the potential of its Opti-mAb technology for innovative antibody therapeutics, it states.

Biotech Business - October 20, 2025

Xbrane provides disappointing regulatory update on FDA review

The FDA has issued a Complete Response Letter (CRL) to the company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate for treatment of retinal disorders.

Biotech Business - October 14, 2025

First patient treated with BioArctic’s Leqembi in the Nordics

Leqembi has now been made available at a private clinic in Finland and that the first patient has started treatment.

Biotech Business - October 10, 2025

Zelluna receives positive MHRA feedback

Zelluna has received positive feedback from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) following recent scientific advice.

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