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...

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

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...

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, ...

First preterm infants study – a vital step for Neola

After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...

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...

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

Kraftig viktnedgång i nya Novo Nordisk-studier

Två aktuella läkemedelsstudier från Novo Nordisk visar betydande viktminskning hos personer med fetma utan diabetes. Wegovy och det nya läkemedlet amycretin vis...

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...

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...

Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pi...

High-performance Slide Scanner for Fluorescence, Brightfield and Polarization

ZEISS Axioscan 7.

Success for Genmab's antibody-drug conjugate

The Danish company Genmab has received Japanese approval for its treatment for advanced or recurrent cervical cancer.

Quality assurance for research and development of medical devices

Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.

Icelandic pharmaceutical company Alvotech to list on Nasdaq Stockholm

One of Iceland's largest companies, the pharmaceutical firm Alvotech, has announced its intention to list on Nasdaq Stockholm.

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

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.

Positive trend for Swedish medtech exports – “We have new markets that are huge”

In 2024, Swedish exports of pharmaceuticals decreased for the first time in several years. However, the trend for medical technology looks brighter. During a se...

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 ...

Quality solutions for medical device R&D applications

From R&D to the quality assurance of series production in medical device manufacturing.

Achieve Efficient, Fast Targeting of Your Sample

Step into the future of imaging technology with VersaXRM 730.

Automated nitrogen analysis reduces costs per sample

N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo