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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.

De är Sveriges högst rankade forskare

På en lista med över 6 600 framstående forskare finns nära 50 forskare från svenska institutioner med.

Sweden and Denmark – this is how they choose their strategies

Scandinavia’s two major powers in pharmaceutical research have developed strategies for growth in life science, and both countries aim to become world leaders.

Han är ny vd på Brighter

Healthtechbolaget Brighter har utsett Erik Lissner till tillförordnad vd och hoppas att turbulensen kring ledarskapet är över.

Så rankas forskarna i covid-debatten

Forskarkritiken mot Sveriges agerande under covid-19-pandemin har ibland avfärdats med argumentet att den inte kommer från ledande forskare inom fältet. Men den kritiken är felaktig, enligt en stor kartläggning i Expressen.

Calliditas beviljas prioriterad granskning

Calliditas läkemedel Nefecon mot Bergers sjukdom kan bli godkänt av FDA i september.

Marie Gårdmark: Big data evidence generation drives change in the EU regulatory system

Rapid developments in technology have led to the possibility for the generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? In a column Marie Gårdmark, CEO and Senior Consultant at RegSmart Life Science, develops her views on this subject.

Oncopeptides har ansökt om tillstånd för kliniska studier i USA

Oncopeptides planerar att påbörja kliniska studier i USA med deras andra läkemedelskandidat för patienter med multipelt myelom.

Combining two drug delivery strategies to improve bioavailability

Danish researchers hope to increase the bioavailability of low solubility drugs.

Delivering drugs with small devices

There are many challenges to overcome when delivering a drug orally. Getting the drug to survive the low pH of the ventricle and being released at the correct site in the gastrontestinal tract are two of them.

Giulia Gaudenzi: ”Key lessons from global health research”

The world will still face major challenges in the post Covid-19 pandemic, writes Giulia Gaudenzi at the KTH Division of Nanobiotechnology at Scilifelab, in a column.

From spin-off to phase II

”The people there will basically become your new colleagues” – Carina Schmidt, former CEO of Athera, about working with different contractors.

Förklarar forskning med animerad film

Tecknade filmer ska förklara avancerad vetenskap för barn och för allmänheten. Det är förhoppningen med the Fair Journal, en vetenskaplig tidskrift som grundats av KI-forskaren Jonas Nørskov Søndergaard. Nu gäller det att få in de första artiklarna.