Will the FDA’s new transparency policy extend to medical devices? (Part 1)

In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...

Webinar: Can AI replace humans in pharmacovigilance?

The webinar will explore how AI can transform pharmacovigilance by enhancing efficiency, reducing errors, and addressing challenges such as software costs, data...

A new scientific event in Gothenburg

Life Science Sweden is holding an event in Gothenburg for the first time.

Billion-Dollar Deal Sends BioArctic Soaring

Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...

A+ Science AB

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

How the Nobel discovery is used in drug development

Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

Positive EMA Decision for BioArctic's New Drug Candidate

Bioarctic's drug candidate for multiple system atrophy, exidavnemab, is recommended to be classified as an orphan drug, according to the European Medicines Agency (EMA).

New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

ZEISS showcases expansion of ophthalmic care options creating industry-leading workflow solutions

ZEISS Medical Technology will showcase new ophthalmic innovations and market milestones at ESCRS 2025 in Copenhagen.

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.

Tau-targeted Alzheimer's drug gets Fast Track designation in the USA

Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).

Meribel Pharma Solna

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

ZEISS Smartzoom 100 for Inspection Efficiency

Catch up on our free webinar.

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Stockholm (2025)

Klartecken för Pharmnovo – kan gå vidare med studie i nervsmärta

Pharmnovo har fått godkännande från spanska myndigheter att genomföra en fas IIa-studie för att pröva bolagets läkemedelskandidat för behandling av neuropatisk smärta.

Charged with illegal pharmaceutical sales – alleged earnings of 23 million

For at least five years, two men allegedly carried out illegal sales of pharmaceuticals and supplements, amassing millions. They are now facing charges at Söder...

Astra Zeneca faces potential multimillion-dollar fines in China

Astra Zeneca could be forced to pay up up to $8 million in fines for allegedly unpaid import duties in China, as the company seeks to rebuild trust following ea...