NLS Biotech News

Intellectual Property – April 23, 2025

BioArctic receives European patent for exidavnemab

The European Patent Office, EPO, has issued a decision to grant European patent for exidavnemab, a drug candidate being developed as a treatment for synucleinopathies such as Parkinson’s disease and Multiple System Atrophy (MSA).

Biotech Business – April 28, 2025

CHMP recommends approval of Camurus’ Oczyesa

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa, octreotide subcutaneous depot, for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Biotech Business – April 28, 2025

Cellevate, Fraunhofer IBMT and OLS consortium awarded EUR 1 million

Cellevate, Fraunhofer IBMT (Institute for Biomedical Engineering), and the German bioreactor company OLS (Omni Life Science) have been awarded a EUR 1 million grant through the Eurostar program for large scale production of iPSCs (induced pluripotent stem cells).

Biotech Business – April 22, 2025

Zelluna reaches milestone – Manufacturing process established

Zelluna has developed, scaled and automated its manufacturing process for its TCR-NK cell therapies.

Biotech Business – April 15, 2025

EU approves Leqembi for treatment of early Alzheimer’s disease

The European Commission has granted BioArctic’s partner Eisai’s application for Marketing Authorization of Leqembi (lecanemab) in the European Union (EU).

Clinical trials

Clinical Trials – April 13, 2025

Orexo and Abera Bioscience announce positive data

The companies have announced positive in-vivo proof-of-concept data for a powder-based intranasal vaccine candidate formulated with the AmorphOX technology. The data was generated under the collaboration between Orexo and Abera Biosciences entered in December 2024. The aim of the collaboration is to develop mucosal vaccines by combining Orexo’s powder-based drug delivery technology AmorphOX with Abera’s […]

Clinical Trials – April 9, 2025

New clinical trial map launched in the EU

A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS).

Clinical Trials – March 25, 2025

Immunovia provides further positive data from the VERIFI study

Immunovia has announced additional results from the VERIFI study of its next-generation pancreatic cancer test, strengthening the company’s position as it prepares to launch the pancreatic cancer blood test commercially.

Clinical Trials – March 18, 2025

Oncorena receives FDA approval to initiate studies in the US

The FDA has approved the company’s IND application to initiate the Phase I/II study Oncorella-1.

Clinical Trials – March 17, 2025

Anocca to start first in-human trial in advanced pancreatic cancer

The company has announced the authorization of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state.

Clinical Trials – February 28, 2025

Evaxion extends phase 2 trial with personalized cancer vaccine

Evaxion Biotech will further enhance the data package from its ongoing phase 2 trial with the company’s lead asset EVX-01 by extending the trial from two to three years.

Clinical Trials – February 24, 2025

Medivir presents positive final phase 1b/2a data

Medivir has presented positive, final data from the phase 1b / 2a study of fostroxacitabine bralpamide (fostrox) + Lenvima in advanced liver cancer (hepatocellular carcinoma/HCC) at the EASL (European Association for the Study of the Liver) Liver Cancer Summit in Paris, France.

Clinical Trials – January 29, 2025

Herantis reports encouraging pharmacokinetic data

Herantis Pharma has announced an update of the ongoing Phase 1b clinical trial of HER-096.

Clinical Trials – January 14, 2025

Orexo announces positive topline data

Orexo has announced positive topline results from the clinical study OX640-002.

Clinical Trials – December 18, 2024

Hansa Biopharma announces positive full results

Hansa Biopharma has announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS.

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 - April 29, 2025

Neogap Therapeutics selected for Innovate Nordics 2025 Acceleration Program

The acceleration program is organized by the Swedish-American Chamber of Commerce in New York (SACCNY) in collaboration with EY.

Biotech article - April 21, 2025

Oncopeptides announces new RWD data

Oncopeptides has announced the publication of new real-world data (RWD) that further support the effectiveness and tolerability of melflufen, branded in Europe as Pepaxti, in patients with relapsed, refractory multiple myeloma (RRMM).

Biotech Business - April 15, 2025

Nykode’s CEO, CSO and CFO have withdrawn their resignations

Nykode announces that Michael Engsig, CEO, Agnete Fredriksen, CSO & Co-founder, and Harald Gurvin, CFO, have withdrawn their recent resignations and will continue with Nykode.

Biotech Business - April 9, 2025

TIRmed Pharma raises EUR 4.3 million

The company has raised financing in a funding round led by Sciety and Sciety Venture Partners.

Biotech Business - April 4, 2025

Orion to open Biologics R&D Centre in Cambridge

Orion Corporation has announced that it is establishing a new research & development centre in Cambridge, UK during 2025 to accelerate its global growth strategy and the development of innovative medicines.