Tagged with P

Spain A roundup of the biggest stories emerging from Spain’s pharma industry: Grifols pushes to improve governance after accusations of overstated earnings; Rovi and Insud join forces to create Spain’s first semi-public pharmaceutical company; Almirall and Eloxx Pharmaceuticals sign a licensing agreement for a rare dermatological disease asset, and Esteve acquires…

USA Since its establishment in 2003, the US President’s Emergency Plan for AIDS Relief (PEPFAR) has saved over 25 million lives and drastically reduced HIV infection rates through antiretroviral treatments. Now well established as the leading global funder of HIV prevention efforts, PEPFAR is supporting high HIV burden countries to meet…

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 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…

France Lionel Collet, president of France’s Haute Autorité de Santé (HAS), explains the role of the independent public authority, which extends beyond health technology assessment (HTA) to clinical practice guidelines and certifying hospitals, and its unique position as a separate body outside of the Ministry of Health. He describes France’s early…

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…

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…