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 –...

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...

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...

Multiplex immunofluorescence chemistries with ZEISS tissue multiplexing workflow

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

Recipharms AI-satsning får stöd från Gates-stiftelse

Svenska Recipharm får utökad finansiering från Bill & Melinda Gates Foundation för att utveckla AI-drivna tillverkningsteknologier. Syftet är att sänka produkti...

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...

Success for Genmab's antibody-drug conjugate

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

ZEISS Lightfield 4D for instant volumetric high-speed imaging

Capturing physiological and neuronal processes in 3D.

Efter Trumps utspel – FDA godkänner behandling för autism

Den amerikanska läkemedelsmyndigheten FDA har inlett en process för att godkänna leukovorin som behandling för vissa personer med autismsymtom.

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...

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.

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...

Orexo får USA-stöd för överdosläkemedel vid blandmissbruk

Uppsalabolaget Orexo har fått 8 miljoner dollar, motsvarande 75 miljoner kronor, av den amerikanska myndigheten Barda för att ta fram ett nasalt räddningsläkeme...

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.

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...

A cluster contribution to European life science innovation and competitiveness?

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.

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.

Getinge and Neobiomics received Swecare's export awards

Two companies received awards during Swecare's annual conference.

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 ...

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.

Karolinska och Akademiska utökar ATMP-samarbete

Ett fördjupat samarbete mellan Karolinskas centrum för avancerade terapier och motsvarande centrum i Uppsala syftar till att ge fler patienter tillgång till cel...

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...

Neogap värvar tungt namn inom cellterapi

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