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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...

The FDA’s new transparency policy (Part 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

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 ...

Astra Zeneca’s asthma drug nears approval for sinus inflammation

Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.

A+ Science AB

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...

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.

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...

Merck Life Science A/S

Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel

USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.

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.

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...

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...

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

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...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

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...