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“Don’t postpone the transition to IVDR”
Operators who have not yet started to adapt to the requirements of the new EU IVDR regulation are running out of excuses. This is the opinion of Helena Dzojic, Head of Unit at the Swedish Medical Products Agency, who continues to persistently spread her message: don’t postpone the transition.
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Myndighet varnar för att skjuta upp övergången till IVDR
Ursäkterna börjar ta slut för aktörer som ännu inte inlett anpassningen till kraven i EU:s nya regelverk IVDR. Det menar Helena Dzojic, enhetschef på Läkemedelsverket, som ihärdigt fortsätter att sprida sitt budskap: vänta inte med övergången.
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Failed to read the fine print – lost his life’s work
A celebrated CEO and co-founder of a pioneering lab company one moment – the next, fired, kicked out and written out of the company’s history. This is the story of a Swedish entrepreneur who was going to raise US venture capital to strengthen his company but lost his life’s work instead.
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Byggstart för svenska innovationsklustret – fördubblar sin yta
Nu tas första spadtaget för Goco Active Lab, ett nytt nationellt center som ska stärka svensk life science.
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The International Vaccine Institute’s office in Sweden is expanding
The International Vaccine Institute’s Stockholm office has been open for over a year. During the past year, training programmes and projects have been launched, says Anh Wartel, Head of the office.
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Internationella vaccininstitutets kontor i Sverige växer
Internationella vaccininstitutets kontor i Stockholm har nu funnits i över ett år. Under året som gått har utbildningar och projekt dragits i gång, berättar Anh Wartel, chef för kontoret.
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700 personer varslas i Region Sörmland
Region Sörmland ska minska sina kostnader med en halv miljard kronor under nästa år och har anmält ett varsel för 700 medarbetare. Regionens läkemedelscentrum är en av de verksamheter där antalet anställda kan minska.
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Uppsala-based company wins important patent dispute – but the decision is subject to appeal
A US district court has ruled in favour of Orexo in a dispute over the patent protecting the Swedish company’s drug Zubsolv, developed for treating patients with opioid addiction. However, the opposing party, the Indian company Sun, is not giving up and has filed an appeal.
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The Swedish Life Science Office: “We lost in both coordination and manpower”
Since the turn of the year, the Swedish government’s life science office has operated at a lower capacity. Life Science Sweden has spoken to Pontus Holm, Departmental Secretary at the office, about the ongoing work.
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Lucy Robertshaw: Artificial intelligence – is this really going to transform a patient’s life?
In a column Lucy Robertshaw reflects on how AI and new regulations will affect healthcare, innovation and the lives of future patients.
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Getinge stärker närvaron på läkemedelsområdet i miljardaffär
Getinge förvärvar amerikanska High Purity New England, som tillverkar engångsprodukter för bioprocesser. Den svenska medtech-jätten betalar närmare 1,3 miljarder direkt, men affären kan växa till att kliva över tremiljarderstrecket.
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The first Lyme disease vaccine faces a delay
Pfizer and Valneva’s Lyme disease vaccine, which could be the first of its kind, is facing delays of about a year. The reason is problems at trial sites in the United States, which have forced the companies to drop half of the participants in an ongoing Phase III study.
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Borreliavaccin försenas efter strul med studie
Pfizers och Valnevas borreliavaccin, som kan bli det första i sitt slag, försenas med åtminstone ett år. Orsaken är problem vid prövningssajter i USA som tvingat bolagen att stryka hälften av deltagarna i en pågående fas III-studie.
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He got inside the head of Sweden’s vaccine hunter
The hunt for the COVID-19 vaccine is the theme of the new book Vaccinjägaren (The Vaccine Hunter). It tells the story of Richard Bergström’s mission as Sweden’s national vaccine coordinator and the scheming that went on behind the scenes in Europe. Author and medical journalist Nils Bergeå co-wrote the book with Richard Bergström.
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Kristdemokraterna rekryterar från Sanofi
Jonas Sareld, Public Affairs Manager vid Sanofi, blir kanslichef för Kristdemokraterna i Region Stockholm.
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Vinnova is going to establish a new innovation cluster
Vinnova, the Swedish Agency for Innovation Systems, has been commissioned by the government to establish a national innovation cluster for advanced medicines.
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Individual DNA passport could result in fewer drug side effects
You may be required to show a DNA passport when you pick up medicines at the pharmacy in the future. According to a new study, patients might suffer 30% fewer side effects if the drug treatment is adapted to their genes.
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Sweden is organising a large life science conference as part of the EU presidency
On 26-27 June, Sweden will host a European meeting on life science.
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Spray med koppar ska döda virus
Ett amerikanskt forskningsteam har utvecklat en antimikrobiell spray som avger ett tunt lager kopparnanotråd. Denna ska kunna användas på offentliga ytor för att minska spridning av bakterier.
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Corline Biomedical tecknar avtal med Smerud för fas II-studie
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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.
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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 says in an interview with Life Science Sweden.
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Karolinska institutet får en halv miljard i forskningsanslag
Vetenskapsrådet beviljar 1,1 miljarder kronor till forskning inom medicin och hälsa fördelat på 14 lärosäten.
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Hård branschkritik mot planerade avgiftshöjningar
De aviserade avgiftshöjningarna för läkemedelskontrollen oroar branschen, som befarar att svensk konkurrenskraft ska drabbas.