Fritextsökning
Innehållstyper
-
ZEISS supports the transition of spatial biology to clinical research
Slide scanner ZEISS Axioscan 7 spatial biology provides scalable workflow automation.
-
Startskott för Gesyntas endometriosstudie: ”Milstolpe”
Gesynta Pharma har doserat den första patienten i sin fas II-studie med läkemedelskandidaten vipoglanstat mot endometrios.
-
Phase III win for Hansa Biopharma: “We Are Thrilled”
Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.
-
Eli Lilly Recruits Leading Swedish Researcher Kaj Blennow to Head Alzheimer’s Project
Eli Lilly recruits Kaj Blennow, leading Alzheimer’s researcher, as VP of neuroscience biomarker development.
-
Heart Monitoring in Breast Cancer – Essential or Excessive?
Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...
-
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.
-
The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
-
FDA-toppar vill skrota tvåstudiekravet
Det kan räcka med en enda avgörande studie för att få ett nytt läkemedel godkänt i USA. Det budskapet levererar FDA-chefen Marty Makary och läkemedelschefen Vin...
-
Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
-
Billion-Dollar Deal Sends BioArctic Soaring
Swedish Alzheimer-focused company BioArctic has entered into a licensing collaboration with Novartis regarding a technology aimed at enhancing efficient drug de...
-
Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
-
Who pays for Rebecca Doe – and all of us?
Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it
-
New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”
Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...
-
Söker godkännande – efter studie med två patienter
Det amerikanska biotechbolaget Prime Medicine planerar att lämna in en ansökan om FDA-godkännande av en genterapi som bara testats på två (!) patienter.
-
He takes over the chairmanship of Karolinska Development
Ben Toogood is appointed as the new chairman of Karolinska Developments.
-
The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
-
Fundamental Aspects of Airy Disk Patterns
Knowledge Article from ZEISS.
-
Astra Zeneca’s asthma drug nears approval for sinus inflammation
Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.
-
Anna Törner: Sänker FDA kraven på kliniska data?
Är den amerikanska läkemedelsmyndigheten FDA på väg att sänka ribban för att godkänna nya läkemedel? Den frågan ställer sig Anna Törner i en krönika – där hon o...
-
Musstudie: Cancer kan ge skydd mot Alzheimers sjukdom
En molekyl som produceras av cancerceller tycks kunna ge visst skydd mot Alzheimers sjukdom, enligt studier i möss.
-
In search of Marcel Proust's lost health
A great writer, but also a weak person and a hypochondriac. That has been the usual image of Marcel Proust. But the pediatrician and literary scholar Carl Lindg...
-
Finland leder vägen i jakten på internationella toppforskare
Just nu pågår flera nordiska initiativ för att rekrytera internationella toppforskare. Finland gör sin största nationella satsning någonsin på att värva ledande...
-
Roche joins Medicon Village
Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...
-
FDA’s Top Vaccine Official resigns – Issues sharp criticism of Kennedy
FDA’s Top Vaccine Official is leaving his post while simultaneously criticizing the country’s health secretary for allowing “misinformation and lies” to influen...
BREAKING