Tagged with M

UAE Long-established as the Middle East and Africa’s leading country in terms of rapid access to biomedical innovation, the UAE is looking to bolster this positioning in the coming years. Indeed, allowing innovation to flourish – including through hosting greater numbers of clinical trials in the country and protecting intellectual property…

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…

Mexico While the COVID-19 pandemic revealed vulnerabilities that sent many organizations looking for ways to bring supply chains closer to home, geopolitical tensions have also encouraged companies to avoid dependence on China. MedTech, like the automotive sector, is turning to Mexico where it can easily reach the vast North American market…

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…

Middle East & Africa Roula Youssef Halabi, SVP Global Fertility Services, discusses her six-year journey at CooperSurgical, establishing a footprint in the Middle East, overcoming cultural biases as a female executive and the shift that has led GCC countries to increasingly recognize the importance of women’s health. She also speaks about the need for…

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 Rami Rajab, CEO of the medical devices trade association, MECOMED, walks us through the organization’s current priorities, including its focus on Saudi Arabia in light of the kingdom’s ongoing transformation, and the creation of the UAE Regulatory Authority for Medical Devices (EDE). In addition, he reviews the challenges surrounding digital…

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…

France FACOPHAR Santé is the French association for actors operating in the natural and herbal remedies field. In conversation with PharmaBoardroom, long-term president Jacques Vernin explains how the organisation promotes French excellence in botanicals and highlights two important new initiatives: an FDA GMP certification programme which has opened up fresh export…

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…