Anna Törner: ”Orphan Designation – the "petite robe noire" of drug development”

It is easy to cling to various regulatory incentives, like orphan designation, and other expedited pathways, without understanding what they truly mean or wheth...

Trögt för genterapi mot blödarsjuka – kan dumpas av bolaget

Roctavian, en genterapi mot blödarsjuka som sågs som ett medicinsk genombrott, har floppat kommersiellt. Nu planerar företaget bakom att avyttra läkemedlet från sin portfölj.

Meribel Pharma Solna

Her company is developing a new tablet form obesity drug

Obesity and diabetes are the primary targets of a new tablet treatment under development by Malmö-based Pila Pharma. The company’s ambition is to take on the bi...

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...

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.

What will be the next big hype after obesity? – An expert panel highlighted their top picks

What will be the next big trend in life science? Everything from Alzheimer’s, Crispr and Omics were highlighted when the issue was debated at this year’s major ...

Pharma Outsourcing – Find the Right Partner (2025)

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

Investment CEO: “The Nordics are outstanding in creating successful medtech companies”

Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...

Automated nitrogen analysis reduces costs per sample

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

From lab to patient – the art of developing new antibody therapies

For 25 years, Danish company Genmab has been developing antibodies and has managed to get several drugs all the way to the patient. Esther Breij has been along ...

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.

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...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

Vaccinskeptiker ny ordförande för amerikansk covid-kommitté

Enligt professor Retsef Levi kan mRNA-vacciner orsaka allvarlig skada och död och bör därför omedelbart dras tillbaka. Nu har han utsetts till att leda arbetsgr...

Cytel Inc acquires the SDS Group

The multinational statistical software developer and contract research organization Cytel Inc, headquartered in Massachusetts, USA, acquires the Swedish consult...

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...

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...

Svenskutvecklad ”symaskin” för kirurgi godkänns i USA

Skånebaserade Suturion, som utvecklar ett slags symaskin för förbättrad bukkirurgi, har fått sin produkt FDA-godkänd och nu väntar lansering i USA.

JMP Statistical Discovery

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

Introducing ZEISS arivis Pro 4.2

ZEISS arivis software enhances custom microscopy image analysis.

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...