Medivir i möte med FDA: "Positiv återkoppling"

Forskningsbolaget Medivir har genomfört ett så kallat pre-IND-möte med den amerikanska läkemedelsmyndigheten FDA.

“Photon counting in computed tomography is the holy grail”

Erik Fredenberg, a researcher in physics at KTH and GE, is working to implement photon-counting CT in clinics. To shorten lead times and reduce the radiation dose in patients, he is setting out to develop a framework for virtual clinical trials for the technology.

He is zooming in on topical preparations

According to Zelmic CEO David Sagna, topical products in drug development is a growing market, and to keep pace with the development, the company is awaiting approval for its new GMP facility.

Stort vetenskapsmöte igång i Life City

Marie Gårdmark: Potential step change – EU regulators get to play with data

A new pilot from EMA is starting in September to assess wether the analysis of 'raw data' by regulatory authorities improves the evaluation of marketing approval for new medicines. Marie Grådmark writes in a column that she is looking forward to the outcome of the pilot to hopefully then understand if “in house” analyses actually will add value.

Amorphous materials take centre stage when Orexo develops new formulations

Swift resolution but with maintained stability. Orexo’s new drug delivery platform tackles the problem of amorphous materials. “Our technology has the positive properties of the material, and it also cracks some of the problems,” says the company’s Research and Development Manager Robert Rönn.

Collaboration for a simpler production of gene therapies launched

A collaboration between universities and companies aims at providing better production methods for the development of gene therapies. The initiative is led by Johan Rockberg, Professor at KTH.

IVI’s Director General on establishing in Sweden: Will need up to 40 employees

The International Vaccine Institute, IVI, hopes to have its first staff on-site in Stockholm within a couple of months, says the institute’s Director General Jerome Kim in an interview with Life Science Sweden.

Tougher competition as the Novo Nordisk Foundation broadens its programme

Søren Nedergaard has worked with innovation at the Danish Government Offices and the University of Copenhagen. Today, he is COO of the Novo Nordisk Foundation, which has recently broadened its programme for leading innovators in medical research to apply to the entire Nordic region.

When carelessness, forgetfulness and coincidence become the researcher’s best friend

Forgetfulness, coincidence and a stroke of luck hardly make up a fruitful method of serious research. Or do they? Actually, a number of important medical advances have come about thanks to completely random incidents and the open-mindedness of scientists who were ready to think outside the box.

Key2compliance expanderar till Danmark

För första gången etablerar sig medicinteknik- och läkemedelskonsulterna Key2compliance utanför Sveriges gränser.

Björn Ursing: Physicians new role in AI driven healthcare

”AI could be the key we need for tomorrow’s healthcare, but it is not a stand-alone tool”, writes Björn Ursing in a column about how the role for physicians changes in the era of AI.

BMS stämmer svenskt forskningsbolag för patentintrång

Den globala läkemedelsjätten Bristol-Myers Squibb (BMS) stämmer det svenska forskningsbolaget Xspray Pharma för patentintrång kopplat till läkemedelskandidaten Dasynoc.

Stockholm aims at becoming one of the world’s top life science regions

Regional Chair for Finance, Irene Svenonius (M), believes that Stockholm can realise the goal of becoming one of the world’s top 5 regions in life science by 2025. One step on the way to achieve this is by hosting a world-leading congress in medtech.

Ilya Pharma utvecklar behandling mot bieffekter av immunterapier mot cancer

Uppsalaföretaget Ilya Pharma planerar att inleda kliniska studier med sin läkemedelskandidat ILP100-Oral för patienter som drabbats av enterokolit, tunn- och tjocktarmsinflammation, till följd av cancerbehandling.