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Alert from the Swedish Medicines Agency: Many complications with gastric balloons
According to the Swedish Medicines Agency, an increasing number of serious complications are being reported in procedures with gastric balloons as a method for ...
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Öppen frågestund: Regulatory Opportunities for Rare Diseases/Orphan Products in US and EU
Anmäl dig till vår nästa session av Office Hours den 28 februari klockan 15:00 (svensk tid), en öppen frågestund om utveckling av särläkemedel (orphan drugs).
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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 approva...
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Pharma Relations AB
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“We need to build flexible operating theatres”
Flexible operating theatres, micro-sensors on surgeons to monitor their well-being and 3D images projected onto organs to be operated on. These are a few ideas ...
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The TFS family is growing
TFS HealthScience is a European based CRO company with broad expertise and experiences in the biotech and pharmaceutical sector. The company is growing and the ...
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Lillys fetmaläkemedel godkänns mot sömnapné i USA – men inte i EU
Viktminskningsläkemedlet Zepbound (tirzepatid) godkänns av den amerikanska läkemedelsmyndigheten FDA som den första läkemedelsbehandlingen för måttlig till svår...
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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...
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Webinar: How to Plan And Analyze a Real-World Evidence Study
This webinar is for drug developers who want to understand the basic ideas of analyzing an RWE study, as well as avoiding the most common pitfalls.
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New study: Post-Covid symptoms are common even after mild Covid-19
According to researchers at the University of Gothenburg, loss of smell and taste, shortness of breath and chest symptoms are the most common complaints after a...
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Start-up developing ”digital twin” received award during the EIT Health Summit
A biotech company, a medtech company and a company in digital health were on the podium when the EIT Health Catapult awarded its winners.
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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 ...
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KI’s new President: “We need to work closer together”
A closer link between research and education and a stronger “we-feeling” are aims that Annika Östman Wernerson sets out to achieve as the new President of Karol...
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New diagnostic test soon ready for the market
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Lonza
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ZEISS presents the "Quality Innovation Summit"
A global event on the future of quality assurance.
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SGS Fimko Ltd.
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Anna Törner: Kalashnikovs in a new guise
Thanks to resisting European regulatory authorities, Europe has been spared the opioid epidemic. In the 1960s, the situation was the opposite as the American ph...
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No demand for new Covid vaccine – “It will probably be discarded”
So far, just under 6 000 doses of the Covid vaccine from Novavax have been used in Sweden, leaving over 1.4 million doses in stock. “They will probably be disca...
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Bud på Biotage – värderas till över 11 miljarder
Uppsalabaserade Biotage meddelade på tisdagen att det amerikanska investmentbolaget KKR har lagt ett kontantbud på biotechbolaget.
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BioVentureHub CEO: “Companies with a high degree of interaction achieve greater success”
For the first time since its inception, AstraZeneca’s BioVentureHub can now recruit new companies, as some of its tenants have grown significantly and are leavi...
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Trumps nya FDA-chef varnar för "massiv övermedicinering"
Donald Trump har nominerat kirurgen och författaren Marty Makary till ny chef för den amerikanska läkemedelsmyndigheten FDA, som enligt den tillträdande preside...
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Webinar: Medtech quality and regulatory compliance
This webinar is for you who are developing or planning to develop a medical device, combination, or borderline product. In one hour, we will discuss what you ne...
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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.