New rules for diagnostic products, but who will certify them? “An extreme shortage area”

In less than two weeks, new and stricter EU rules will enter into force for thousands of products used in important diagnoses of, among other things, cancer and Covid-19. However, not one single institute in the entire Nordic region is able to certify the diagnostics companies’ products according to the new regulations. “In the end, it risks affecting patients,” says Anna Lefèvre Skjöldebrand, CEO of Swedish Medtech.

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.

Marie Gårdmark: Finally, it’s time for a revision of the EU pharma legislation

A challenge for the EU Commission is to deliver a new framework that will also take care of another “pillar” of the pharmaceutical strategy, namely, to ensure that new medicines will be available for all citizens in Europe, writes Marie Gårdmark in a column.

The route to vaccines for everyone: “We did not just sit around and wait”

The pandemic was in full swing, and no one knew when or even if a vaccine would come. At that point, the Swedish Minister of Social Affairs called with a proposal, and Richard Bergström did not hesitate. “I already had a notion that this would work,” he

Anna Törner: Success requires bold decisions!

“Doing things right is fine, but doing the right things as soon as possible is even better”, writes Anna Törner in a column.

MVA:s CEO: “Our investments should improve people´s everyday lives”

Involuntary infertility and diabetes are two of the areas on the agenda of the Medicon Valley Alliance.

Norway finds its path in life science

The life science sector in Norway is on the rise.

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.

Swedish Healthtech Company 1928 Pushing Forward

The full service analytics platform is expanding the business.

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.

”Det börjar dyka upp produkter på marknaden som inte ska vara där”

Aldrig har utvecklingen av diagnostik gått så snabbt som nu och nya självtester för covid-19 dyker upp i snabb takt. Samtidigt slinker självtester som inte lever upp till regelverket igenom. ”Jag känner i dagsläget inte till något CE-märkt självtest för covid-19”, säger Helena Dzojic från Läkemedelsverket.

"Det handlar ju om liv, även efter corona"

Krönika: Collaboration across borders

Drug development creates new challenges for regulators

Active biotech byter inriktning

Forskningsbolaget väljer ny inriktning för bolaget. Ögonsjukdomar, blodcancer och Crohns sjukdom står i fokus.

A world-class research village

Eight years ago, Medicon Village was set up in Lund. Since then, this hub for research, innovation and business has developed enormously, and today the life science village is home to over 150 organisations, employing more than 2,200 people.

Engage with your CMO early

Gordon Hutton is Materials Science Lead at Thermo Fisher Scientific’s, formerly GSK, small molecule API site in Cork, Ireland.

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.

Before you choose a CRO

– We are a small company and it is very important for us to maintain our core competence within development of novel nanomaterials, Tove Sivik Sonne, Head of Development at Spago Nanomedical says.

LabDays: ”Det är en ganska mörk bild jag pekar ut nu”

Utmaningar inom global hälsa, analys av torkat blod, gensekvensering, manlig infertilitet och detektion av droger i saliv var några av de ämnen som avhandlades under seminariet Lab & Diagnostics of the Future.

Biomarkörer, salivprov och patientnära tester

Salivprov som kan ersätta urinprov vid spårning av droger, biomarkörer vid bröstcancer och patientnära diagnostiska tester – detta och mycket annat tas upp under det fullmatade Lab & Diagnostics of the Future 2-3 oktober på Stockholmsmässan.

Kognitiv träning skyddar dåligt mot demens

Att träna kognitiva förmågor ger inte skydd mot demens. Inte heller ger träningen någon generell förbättring utan man blir bra på det man tränar.

Brexit creeping closer – or?

In this column, lawyer Pernilla Norman, tries to sort out the different Brexit options.

”Guldår för cancerområdet”

Vi lever i en gyllene era för möjligheten att behandla cancer. Det säger Susan Galbraith, chef för Astrazenecas onkologi. "Avgörande för att kunna skörda av framgångarna är tidig och exakt diagnos", säger hon till Life Science Sweden.