Tagged with EG

Saudi Arabia Over the past three years, Sanofi has significantly expanded its presence in the GCC region, launching 40-50 new products, including treatments for rare diseases and advancements in immunology, diabetes management, and vaccines. As Jean-Paul Scheuer explains, this expansion aligns with Sanofi’s goal to become a leading immunology company globally and…

Europe Writing in DIA’s Global Forum magazine for June 2024, the organization’s Vedran Raguz reviews some of the key takeaways from DIA Europe 2024, namely the need for increased collaboration, alignment and harmonization among international regulatory bodies and stakeholders.   One of the overarching themes of DIA Europe 2024 was the imperative of…

Saudi Arabia Abdul Latif Jameel is one of Saudi Arabia’s most storied distributors, with a history dating back to 1945. Although present in the healthcare space since 1995 via its philanthropic activities, it has only recently moved to set up a dedicated healthcare arm, known as Jameel Health. Led by Big Pharma…

India Halewood Laboratories’ Sanchit Chaturvedi discusses the impact of taking on a leadership role in a challenging personal moment; the company’s enduring commitment to innovation and quality; and its planned expansion into new international markets.   Success in business requires more than just aggression—it requires strategy, understanding, and relentless dedication Could…

India In the words of Founder and Chairman Kaushik Chaturvedi, Halewood Labs’ success since its foundation in the early 1980s can be put down to three key factors: vision and commitment, family and cultural values, and quality and innovation. Chaturvedi describes the company’s journey up to this point and what is…

China After a glittering career in corporate America, in 2011 Jasmine Cui returned to China and in 2015 launched her own biotech, Innocare. The firm, which focuses on oncology and autoimmune disease R&D, now has an extensive pipeline, with a BTK inhibitor for hematological cancers holding particular potential. In conversation with…

China Since first establishing an affiliate in China back in 2017, Gilead Sciences has been able to introduce 11 innovative medicines to the Chinese market – eight of which have been included in the National Reimbursement Drug List – across HIV prevention & treatment, viral hepatitis, invasive fungal disease, and cancer.…

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…