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Lundbeck får genombrottsstatus i Kina för nytt epilepsiläkemedel
Danska läkemedelsbolaget Lundbeck har fått Breakthrough Therapy Designation i Kina för sin läkemedelkandidat bexicaserin, avsett för behandling av anfall vid ut...
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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Novo Nordisk tells staff to return to office
At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...
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Joy at Egetis after positive CHMP opinion – ”The single most important milestone”
Stockholm-based Egetis Therapeutics has received a positive CHMP opinion for Emcitate, which could become the first approved treatment for the rare disease MCT8 deficiency."
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EMA review confirms a risk of new cancer after CAR-T
CAR-T cancer therapies can, in rare cases, induce secondary cancers. The European Medicines Agency (EMA) now recognises this and requires a warning label to be attached to the product...
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Abbvie förvärvar lovande projekt inom psykisk ohälsa
Abbvie köper ett läkemedelsprogram inom mental hälsa i en miljardaffär som ser lite annorlunda än vad som tidigare uppgetts.
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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, ...
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Anocca raises SEK 440 million ahead of clinical cancer trial
Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.
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First preterm infants study – a vital step for Neola
After years of developing an advanced lung monitoring system, Neola Medical has received some delightful news: permission to start its first clinical study on p...
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Abbvie ryktas överväga miljardförvärv inom mental hälsa
Läkemedelsbolaget Abbvie uppges föra diskussioner om att förvärva Gilgamesh Pharmaceuticals, ett bolag inom mental hälsa, i en affär som ska ligga på omkring en miljard dollar.
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Grönt ljus för Gesyntas endometriosstudie i Storbritannien – ”Ett stort steg”
Gesynta Pharma har fått klartecken i Storbritannien för att inleda en fas II-studie med sin läkemedelskandidat inom endometrios.
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Danish biotech to buy struggling American oncology company
Danish drugmaker Pharmacosmos has agreed to acquire American pharmaceutical company G1 Therapeutics in a deal that amounts to 405 million dollars.
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The art of successful licensing – “A lot has to align”
Sharp research, strong data and a high level of innovation are all very good, but more than that is required to achieve the goal of many biotechnology companies...
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Wegovy slog Mounjaro i studie om hjärtinfarkt
Under söndagen presenterade Novo Nordisk ny studiedata som pekar på att Wegovy kan minska risken för allvarliga kardiovaskulära händelser mer än Eli Lillys konk...
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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AstraZeneca´s Trixeo approved in the UK using propellant with near-zero Global Warming Potential
AstraZeneca has received approval in the United Kingdom for its inhaled respiratory medicine Trixeo Aerosphere with a new propellant that is reported to reduce ...
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Eli Lilly requests re-examination of Alzheimer's drug recommendation
Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.
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Kennedy attackerar dansk vaccinstudie – ”Propagandanummer från läkemedelsindustrin”
USA:s hälsominister Robert F. Kennedy Jr. uppmanar en medicinsk tidskrift att dra tillbaka publiceringen av en stor vaccinstudie, vars slutsatser han ogillar. M...
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Join our measuringhero Jay on the innovation tour
Experience our latest innovation from the Control fair.
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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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Tau-targeted Alzheimer's drug gets Fast Track designation in the USA
Biogen's Alzheimer's candidate BIIB080 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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Quretech granted a European patent for a new type of antibiotic
The European patent provides protection until 2041. Previously, the patent was granted in China, and the application is currently under review in the USA, India, and Japan.
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Recipharm ingår samarbete med global koncern
Recipharm ingår ett strategiskt samarbete med den globala franska koncernen Product Life Group (PLG).
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