Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

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.

The FDA’s new transparency policy (Part 3)

test data. It necessitates strategic foresight, sound regulatory judgment, and a thorough understanding of the Agency’s evolving expectations.

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...

IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

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Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project

Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.

Agreement in the EU on eight years of data exclusivity for new medicines

New pharmaceuticals will be covered by eight years of data exclusivity, according to the proposed new pharmaceutical legislation that EU countries have now agre...

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

Gel mot håravfall lockar miljardinvestering

Det amerikanska bioteknikbolaget Pelage Pharmaceuticals väcker stort intresse med sin regenerativa kandidat mot ärftligt håravfall. Nu tar bolaget in 120 miljon...

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

Bringing leading multiplex immunofluorescence chemistries together in one automated 8-channel imaging platform.

Därför är SEO inte dött: “Viktigare än någonsin”

AI förändrar hur vi söker information – men grunden för att synas på nätet är densamma. För bolag inom biotech och life science är SEO särskilt viktigt: "Förtro...

Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

Wegovy approved in the U.S. for treatment of liver disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...

Pharma Outsourcing – Find the Right Partner (2025)

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

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...

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...