FDA launches investigation into gene therapy following child death

The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The incident is described as likely related to the drug.

Positive EMA Decision for BioArctic's New Drug Candidate

Bioarctic's drug candidate for multiple system atrophy, exidavnemab, is recommended to be classified as an orphan drug, according to the European Medicines Agency (EMA).

Venomaid's rapid test aims to find the right snake bite treatment

Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom can help? Danish company Venomaid Diagnostics is working hard to develop solutions to a problem that claims countless lives, especially in tropical countries.

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership of his life's work – the company Tataa Biocenter. “Not only did they take our company away from us. They followed up by showering us with lawsuits,” he says.

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).

Life science trends 2025 – Neurology

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-brain barrier are being developed. In addition, a new type of drug for MS is making its debut. This part of trend insights on life science 2025 is about neurology.

Licenspartner backar ur – lämnar tillbaka projekt till Affibody

Affibody får tillbaka de globala rättigheterna till izokibeb sedan samarbetspartnern Acelyrin avbrutit sin utveckling av programmet.

He takes over the chairmanship of Karolinska Development

Ben Toogood is appointed as the new chairman of Karolinska Developments.

Lilly recruits top Swedish researcher in Alzheimer´s

One of Sweden's leading Alzheimer's researchers, Oskar Hansson, has been recruited by pharma giant Eli Lilly and will be moving to the USA.

Large study on milk: Risky for women but not for men

The risk of ischemic heart disease (IHD) and acute myocardial infarction (MI) increased for women with milk intake levels higher than 2 glasses per day, while no such association was found in men, according to a new large Swedish study.

From lab to patient – the art of developing new antibody therapies

For 25 years, Danish company Genmab has been developing antibodies and has managed to get several drugs all the way to the patient. Esther Breij has been along for much of the journey and has experienced setbacks, but also huge discoveries. “It’s amazing when you succeed,” she says.

Ancient DNA provides new insights – “The immune system lost its job”

Ancient bone remains from our ancestors have provided new insights into the prevalence of multiple sclerosis. By looking back in time, researchers can provide a possible explanation for why the disease is more prevalent in northern Europe.

Marie Gårdmark: ”Interchangeable biological medicines – soon in a pharmacy near you?”

”Generic competition is an effective way to push down drug prices, but it has not worked equally well for biosimilars. Biosimilars require more time to gain market share compared to generics, and new biosimilars do not always lead to lower prices” writes Marie Gårdmark in a column.

Lista: Största läkemedelsflopparna 2022

Att utveckla nya läkemedel är ingen lek. Inte sällan slutar åratal, kanske decennier, av mödosamt arbete och stora investeringar i svår besvikelse när projektet i slutändan inte klarar krocken med verkligheten i de kliniska prövningarna.

The pandemic caused a reshuffle among the world’s vaccine giants – here is the new top list

Fuelled by the pandemic, the power balance in the global vaccine market has completely changed in recent years, a survey from Fierce Pharma shows

Klaria i spanskt samarbete om munfilm från alger

Uppsalabaserade Klaria Pharma har tecknat avtal med det spanska läkemedelsbolaget Pharmamar om utveckling av en alginatfilmsformulering till en av Pharmamars substanser. En gemensam faktor för bolagen är att bägge utvinner sina produkter ur substanser från havet.

Biosimilars bring price pressure, but are they sufficiently used?

When biosimilars were introduced just over 16 years ago, hopes were raised that they would give many more patients access to effective but otherwise extremely expensive treatments with biological drugs. So, how well has Swedish healthcare used biosimilars? The answer partly depends on whom you ask.

Biosimilarer ger prispress, men används de tillräckligt?

Biosimilarernas ankomst för drygt 16 år sedan väckte hopp om att många fler patienter skulle få tillgång till effektiva men annars mycket dyra behandlingar med biologiska läkemedel. Så hur bra har svensk sjukvård varit på att använda biosimilarerna? Svaret beror, åtminstone delvis, på vem man frågar.

Anna Törner: Success requires bold decisions!

“Doing things right is fine, but doing the right things as soon as possible is even better”, writes Anna Törner in a column.

Affibody i avtal med miljardpotential om kandidat mot autoimmuna sjukdomar

Solnabolaget Affibody har ingått avtal med amerikanska Acelyrin om utveckling och kommersialisering av sin behandling izokibep mot multipla autoimmuna sjukdomar. Potentiellt är affären värd över 300 miljoner dollar, eller 2,7 miljarder kronor, plus royalties.

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.

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.

Pilots want to live too

From spin-off to phase II

”The people there will basically become your new colleagues” – Carina Schmidt, former CEO of Athera, about working with different contractors.