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China BeiGene may not be a profitable business quite yet, but the Chinese biotech has two top oncology products and saw its sales soar to USD 2.2 billion in 2023. Having set its sights on markets outside of China, with its BTK inhibitor Brukinsa already approved across multiple geographies, the company…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the counter medications and other medicinal products? See answer to Chapter 1, question 3.   23. What is the authorization process for the marketing of generic versions of these products? To obtain a marketing…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical…

Pharma Legal Handbook  1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet…

Pharma Legal Handbook  53. What types of liability are recognized in your jurisdiction? Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal…

Pharma Legal Handbook 58. What are the basic requirements to obtain patent and trademark protection?   Patents: The most basic requirements follow from the Norwegian Act relating to patents of 15 December 1967 No. 9 (“the Patents Act”). The Patents Act § 2 stipulate that patent protection may be granted to anyone who…

Middle East & Africa A lot has happened at Olympus since we last spoke with regional managing director for Middle East, Türkiye & Africa Ronald Boueri two years ago. Namely, the MedTech has been working on setting up its regional headquarters in Saudi Arabia. Boueri discusses the importance of the Saudi market, pursuing its…

Japan Some of the biggest stories coming out of Japanese pharma, including Takeda’s USD 2.2 billion Alzheimer’s deal with AC Immune and its plans to restructure; the continuing probe into deaths linked to a Kobayashi Pharmaceutical supplement; Kyowa Kirin’s acquisition of Orchard Therapeutics, and Shionogi’s buy up of Maze Therapeutics’ Pompe…

USA Since founding the HIV advocacy group Prevention Access Campaign (PAC) and launching its Undetectable=Untransmittable (U=U) campaign in 2016, Bruce Richman has been focused on raising awareness around a revolutionary but widely unknown fact: people living with HIV who are on treatment and have an undetectable viral load cannot sexually transmit…

China Cytiva is a global leader in bioprocessing technologies and services that support the manufacturing and research of biopharmaceuticals. China is a key market in the company’s growth story, where – as President of Cytiva in China Allen Li notes – it has shifted from simply offering superior products to engaging…

China Unlike many of its Chinese biotech peers with broad portfolios, Hua Medicine has focused intensively on developing a single product, dorzagliatin, for diabetes. As CEO Li Chen notes, this strategic concentration has allowed Hua Medicine to pioneer in homeostasis control modulation and address specific unmet medical needs in diabetes treatment,…

India Environmental, Social, and Governance (ESG) concerns have grown in global importance in the last few years due to several factors, including increased awareness of and demand for sustainable investing, the need for companies to maintain what McKinsey calls their ‘social license’, and the potential financial benefits of strong ESG performance.…