TFS Trial Form Support AB

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...

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...

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...

GU Ventures AB

Pharma Outsourcing – Find the Right Partner (2025)

Explore 3D Testing of Deformation and Motions

Powerful measurement capabilities with the new ZEISS ARAMIS 1.

Bästsäljaren Keytruda blir enklare att ta – godkänns i subkutan form

MSD (känt som Merck i USA och Kanada) har fått klartecken från FDA och CHMP för en ny variant av sitt storsäljande cancerläkemedel Keytruda. Den nya versionen, ...

The art of successful licensing – “A lot has to align”

Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

Merck KGaA acquires American company in €3.0 billion deal

Germany’s Merck is completing the acquisition of Springwork Therapeutics for 3 billion euros.

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...

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...

US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee

Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...

Novo Nordisk appoints Mike Doustdar as new CEO

The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...

After the threat of tariffs – Novartis invests 230 billion in the USA

Pharmaceutical giant Novartis plans to invest 23 billion dollarsover the next five years to expand its production in the USA. The goal is for all medicines dest...

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

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...

Swetrial tar form – så ska partnerskapet stärka kliniska prövningar

Ett nationellt partnerskap med namnet Swetrial ska skapa bättre förutsättningar för kliniska prövningar. Läkemedelsverket presenterar nu en delredovisning och e...

Lista: Årets mest framstående medicinska uppfinningar

Den subkutana formen av det svenskutvecklade alzheimerläkemedlet Leqembi lyfts fram när Time presenterar sin årliga lista över de bästa uppfinningarna 2025.

Spatial Biology Studies in Lung Tissue using Spectral Microscopy

Spectral imaging with the ZEISS LSM 980 laser scanning confocal enables more complex studies of cell-cell interactions and locations in immunology research.

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it

Neogap värvar tungt namn inom cellterapi

Bioteknikbolaget Neogap Therapeutics fyller på styrelsen med expertis inom cellterapi i form av professor Jonas Mattsson.

Novo Nordisk establishes new factory in Denmark

Novo Nordisk establishes a new production facility in Odense, Denmark, an investment of 8.5 billion Danish kroner.