Tagged with B

China Jimmy Wei founded Chime Biologics over 12 years ago with the vision of establishing a global biologics company in China, focusing on biosimilar development and CDMO services. The company’s growth since then has been influenced by the success of other biologics companies like WuXi Biologics and Samsung Biologics, regulatory changes…

Global The US National Institutes of Health (NIH) is the largest public investor in HIV/AIDS research globally. This means that, as Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy & Infectious Diseases (NIAID) Dr Carl Dieffenbach oversees a global HIV/AIDS research portfolio of more than…

China Boan Biotech CEO Jiang Hua outlines the Luye Pharma-acquired company’s approach, securing stable revenues through its biosimilars while pursuing novel platforms and innovative drug development. She provides insights into the biotech’s six biosimilar products, as well as its main technology platforms – including the foundational Human Antibody Transgenic Mouse platform…

Global Marijn Verhoef, Director of Operations and Research at the Access to Medicine Foundation examines the interconnected challenges of drug shortages and antimicrobial resistance. Verhoef urges decisive and urgent action from the pharma companies that manufacture lifesaving antibiotics and antifungals to ensure that patients can get the right medicine when they…

Middle East & Africa Diederik Kok, Head of GCC, discusses his experience piloting Biogen’s newly established direct presence in the region and reviews its varied neuroscience landscape and the importance of tailoring the organization’s approach. He also speaks about Biogen’s commitment to conducting clinical trials in the GCC, its recent risk-sharing agreement with the…

India India faces a significant diabetes burden, with some observers even labelling the country ‘The Diabetes Capital of the World’. Around 101.4 million adults, or 11 percent of the Indian population, have diabetes.   As Dr Brij Mohan, president of India’s Diabetes & Obesity Centre surmises, Indians tend to develop diabetes…

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…