Denmark: Food, Drugs, Healthcare, Life Sciences

The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin

In this episode, Lea Carina Uhd Frederiksen, a journalist who founded Fantombryg, discusses her unconventional path into the beverage industry with our host, Hanane Fathi Roswall.

Recent U.S. case law is reshaping the risks around skinny labelling strategies for generics. What was once seen as a safe regulatory pathway now raises new concerns about infringement

The EU Council and European Parliament have agreed on a new “Pharma Package” – a major update to medicines rules in Europe. This is one of the biggest reforms in over 20 years. Once finally endorsed by the Council and the Parliament, the agreement will enter into force.

Registration of your company and medical devices in EUDAMED, the EU’s central database for medical devices, will become mandatory from the first half of 2026.

On 13 August, the UPC Court of Appeal held that a marketing authorisation alone is not enough, but once a health technology assessment (HTA), pricing and reimbursement are completed, imminent infringement may be established. Pharmaceutical companies must therefore monitor regulatory steps closely to act in time.

Leadership advisor Tune Hein shares exclusive insights from his five-year experience as an internal specialist at Novo Nordisk during the launch of Wegovy, one of the pharmaceutical industry's most significant obesity drug introductions. What are the 10 core beliefs that propelled Novo Nordisk to become one of the world's most valuable companies, and how did their unconventional approach to scaling, management, and organizational structure drive their success in the competitive obesity drug market?

Polycystic Ovary Syndrome has been officially renamed Polyendocrine Metabolic Ovarian Syndrome following a 14-year global medical consensus. The new terminology better reflects the condition's complex hormonal, metabolic and reproductive nature, moving beyond the misleading reference to ovarian cysts. What does this fundamental shift in medical understanding mean for patent applications and intellectual property strategy in women's health innovation?

The Medical Device Coordination Group ("MDCG") has recently published guidance on the interplay between the AI Act and the MDR/IVDR.