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Giulia Gaudenzi: Innovation for good
"I challenge the innovator landscape to take a mental leap. Relying on innovation-solely to end inequality is not enough, therefore consciously and purposively – we need to engage bravely with the politics of poverty and scarcity. Even in life sciences", writes Giulia Gaudenzi in a column.
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Efter positiva resultat för Valneva: ”Ansökan till EMA skickas så snart som möjligt”
Efter att ha stoppats av Storbritannien ser det nu ljusare ut för Valnevas covid-19-vaccinkandidat sedan positiva fas III-resultat presenterats. Nu väntar ansökan till EMA. "Det behövs mer vaccin eftersom hela världen ska få tillgång till vaccin och kunna vaccinera sig", säger Valnevas Sverige-chef Janet Hoogstraate.
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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.
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ATMP-expert till Eliceras styrelse
Karin Hoogendoorn har valts in i styrelsen för Elicera Therapeutics.
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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.
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Column: Why there cannot be a complete cure for cancer – but there is certainly another way!
"Is there a new way we need to be thinking about how to prevent cancer?" Lucy Robertshaw reflects upon which is the smartest way to beat cancer.
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Column: Repurposing as a golden ticket to approval
"Hopefully, in the end, patients will be winners by receiving on-label treatments for which benefit-risk has been properly assessed." In a column Marie Gårdmark, CEO at RegSmart Life Science, reflects on drug repurposing.
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SDS Life Science satsar på regulatorisk spetskompetens
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New diagnostic test soon ready for the market
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Storbritannien godkänner Pfizers covid-19 vaccin
Vaccinet kommer att finnas tillgängligt på brittiska sjukhus från och med början på nästa vecka.
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Lucy Robertshaw: There is a bio revolution happening right now
Lucy Robertshaw is both proud and excited to be taking the baton of moderating this year’s Pharma Outsourcing event.
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Samtycke från patient – i många fall inte tillräckligt för databehandling
Vilka är konsekvenserna av att den Europeiska dataskyddsstyrelsen uttalat att försökspersoner i de flesta fall inte kan samtycka till hantering av data rörande dem? Advokaterna på Cirio Advokatbyrå reder ut.
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Läkemedelsupptäckt med CRISPR-screening
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Marie Gårdmark: Do EMA and FDA talk to each other?
Of course they do! The collaboration started already in 2003, writes Marie Gårdmark in a column.
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Abigo nyanställer
Life science-företaget Abigo har anställt en ny kommunikationschef och en ny risk and quality specialist.
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Här är vaccinkandidaterna mot coronaviruset
Totalt finns det idag tio pågående kliniska studier om vaccinkandidater mot det nya coronaviruset.
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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.
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Nya chefer på Xvivo
Anne-Li Sigvardsson och Andreas Wallinder rekryteras inifrån bolaget.
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Pilots want to live too
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Drug development creates new challenges for regulators
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Coordination of world-class research facilities
Four unique world-class research facilities are located just a few hours apart. Properly utilised, a Nordic centre for world-leading life science innovation and research could become a reality. Kajsa M Paulsson is the project leader for HALOS, driving the idea forward.
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Krönika: Can regulators keep up with innovation?
New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market
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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.
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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.