Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark. 1. Has an essential or priority drug list been published in your country? (If so provide the link) The guideline process of the Danish Medicines Council results in recommendations with prioritized list of medicines…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark. 1. What is the definition of an orphan drug in your country? The term “orphan drug” usually refers to medicins used for rare diseases – i.e. diseases where the prevalence of the condition in…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark. 1. What is the definition of a vaccine in your country? Danish legislation refers to the definition found in the European Pharmacopoeia. 2. What are the classifications of vaccines in your country? Vaccines…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark. 1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval / b. Pricing Decisions / c. Reimbursement Decisions a. Market approval Please see the detailed…
Pharma Legal Handbook All legal aspects surrounding product liability. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119. 1. What types of liability are recognized in your jurisdiction? Generally, a person or company may…
Denmark After transitioning from a fledgling biotech to a mature commercial-stage company on the back of its first approval, Zealand Pharma was hit with the challenges of commercialisation and the disappointing sales of its severe hypoglycemia treatment, Zegalogue. As a result, in 2022, the Danish firm did an about face, sacked…
Denmark LEO Pharma has been in the midst of a shakeup since the beginning of 2022. After naming a new CEO and announcing a major restructuring, the Danish dermatology pharma has let a considerable number of employees go, closed research centres and restructured its R&D team. While LEO’s financials look promising…
Global Ever since Novo Nordisk launched Wegovy two years ago, the company has struggled to meet the huge demand for its breakthrough weight loss drug and is yet to make it available in a larger range of markets. Following a recent launch in Germany, Novo Nordisk CEO Lars Fruergaard Jørgensen makes…
Denmark Danish allergy specialist ALK will have a new CEO in 2024, with current incumbent Carsten Hellmann set to step down after a seven-year spell in the hot seat. Hellmann, 59, will be replaced by the comparatively youthful 45-year-old Peter Halling at the end of the year, which ALK Board Chairman…
Denmark Denmark has long been a global frontrunner in medical research ethics and now boasts a more robust ethical infrastructure, spearheaded by a new body, The National Centre for Ethics. Head of the Centre’s Science and Ethics Division Helle Harder explains the rationale behind its formation, how ethics covers the quality…
Denmark Henrik Brabrand, CEO of life science-focused executive search firm Albright Partners A/S, gives his expert insight into how to stand out above the crowd and get noticed by headhunters. So, you have decided that you may be up for a new challenge. You may not know it yet, but…
Pharma Legal Handbook Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119. 1. Are biosimilar medicines considered the same as generic medicines in…
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