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...

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...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

Pharma Outsourcing – Find the Right Partner (2025)

Trump in new push to lower drug prices

U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...

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...

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.

Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”

Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit

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.

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...

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...

Trump aviserar ny prispress – läkemedelsjättar faller

USA:s president Donald Trump har återigen riktat fokus mot landets läkemedelspriser. Han presenterar nu två separata initiativ för att pressa priserna på diabet...

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...

Phase III win for Hansa Biopharma: “We Are Thrilled”

Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.

Trumps ”lösning” på autismgåtan får forskare att skaka på huvudet

Användandet av paracetamol under graviditeten pekas av USA:s president Donald Trump ut som boven bakom autism, medan ett annat läkemedel med folinsyra – ett sla...

RISE - Research Institutes of Sweden

Texas stämmer Tylenol-tillverkare – anklagas för att ha dolt påstådd autismkoppling

Texas justitieminister stämmer Johnson & Johnson och dess avknoppning Kenvue för att ha dolt misstänkta risker med smärtstillande läkemedlet Tylenol, kopplade t...

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...

Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

Klart: Novo och Lilly sänker priser efter avtal med Trump

USA:s president Donald Trump meddelade på torsdagen att regeringen nått avtal med Eli Lilly och Novo Nordisk om kraftigt sänkta priser på bolagens viktminskning...

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...

Several departures at the top at Nykode

Members of both the management and the board are leaving the Norwegian biotech company Nykode.

Pfizer sänker priser i USA – fler bolag väntas följa efter

Läkemedelsjätten Pfizer är först ut med att utlova sänkta priser på receptbelagda läkemedel i USA efter en överenskommelse med Trumpadministrationen.