Källor: Novo och Lilly nära prisavtal med Vita huset

Amerikanska läkemedelsbolaget Eli Lilly och danska branschkollegan Novo Nordisk förbereder sig för att tillkännage nya prisavtal för läkemedel i en uppgörelse m...

Texas stämmer Eli Lilly för påstådda mutor mot vårdgivare

Eli Lilly stäms av delstaten Texas efter anklagelser om att den amerikanska läkemedelsjätten mutat vårdgivare att skriva ut bolagets läkemedel.

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...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

Mercodia AB

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...

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.

GU Ventures AB

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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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.

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.

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

Pharma Outsourcing – Find the Right Partner (2025)

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...

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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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...

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.

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...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

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...