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...

New diagnostic rules raise concerns

In a panel discussion, several voices from academia and the industry expressed concerns about the transition to the new regulatory framework for in-vitro diagno...

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...

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...

FDA godkänner behandling mot rastlöshet vid Alzheimers

För första gången har amerikanska myndigheter godkänt en behandling mot agitation – ett tillstånd av stark oro och rastlöshet – i samband med demens på grund av...

Tungt namn föreslås ta över klubban i Sobi

Valberedningen i särläkemedelsbolaget Sobi föreslår att David Meek utses till ny styrelseordförande vid en extra bolagsstämma i december.

Promising Alzheimer’s study data sends Bioarctic stock soaring

The drug candidate lecanemab from Swedish company Bioarctic significantly slowed down the deterioration in patients with early on-set Alzheimer’s, according to ...

We will now publish more news in English – and offer yet another newsletter

Starting next week, Life Science Sweden will begin offering a newsletter entirely in English.

Webinar: What is Regulatory Affairs?

This webinar is intended for those who work within the life science sector and would like to gain a general understanding of regulatory affairs for human medicinal products.

Tablet treatment for hair loss approved in the USA

The US Drug Administration has given a thumbs up for the first tablet treatment for spotty hair loss.

Sweden is heavily criticised for not ordering Covid vaccine

Valneva and the EU Commission have entered into an agreement for 1.25 million doses of the company’s Covid vaccine, but Sweden has not placed an order.

Pfizer’s record year – topped the $100 billion mark

In 2022 Pfizer, as the first pharmaceutical company in history, reached an annual revenue of more than 100 billion dollars, thereby surpassing Johnson & Johnson...

How Volume EM Advances Life Science Research

Free webinar series.

He saved lives with his theories – was ostracised and ended up in a mental hospital

Hungarian doctor Ignaz Semmelweis (1818-1865) undoubtedly possessed plenty of persistence, diligence and sound reasoning skills – but he was hardly blessed with...

New diagnostic test soon ready for the market

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.

Fuskanklagat pharmabolag lägger ner alzheimerprojekt

Amerikanska Cassava Sciences avbryter utvecklingen av sin läkemedelskandidat inom Alzheimers sjukdom efter misslyckande i en fas III-studie

Storbolag i gräl om hiv-läkemedel

En träta om påstått vilseförande marknadsföring av hiv-läkemedel mellan läkemedelsbolagen Gilead och Glaxo Smith Kline (GSK) har nu avgjorts – till den senares fördel.

Studienamn med attityd – viktigare än man kan tro

Ironman, T-rex, Star-trec. Popcorn, Proper, Scout. Nej, det handlar varken om fantasyfilmer eller hundnamn. Utan om benämningar på pågående cancerstudier i Sverige.

Åsa Uppströmer ny vd för Pharma Relations

Pharma Relations har anställt Åsa Uppströmer som ny vd.

TCO easy comparison of electric and pneumatic solutions

Find the right technology for your application and compare CO₂ emission and TCO The shown results are not based on a sizing calculation, parameters like service...

Genes from Neanderthals can affect the correct drug dosage

A fifth of all Europeans carry gene variants inherited from Neanderthals, which cause certain drugs to break down more slowly. This may have implications for th...

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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