Tagged with R

Europe The EMA’s Head of Advanced Therapies Dr Ana Hidalgo-Simon outlines Europe’s evolving regulatory framework for regenerative medicines, how it differs from those in the USA and Asia, ethical and pricing challenges, and why global regulatory harmonization and collaboration is crucial.   For advanced therapies, market approval is not the end…

Asia-Pacific On 15 November 2020, the world’s largest trade deal in terms of GDP – the Regional Comprehensive Economic Partnership (RCEP) –was signed virtually by 15 countries: the ten members of the Association of South East Asian Nations (ASEAN) – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and…

Europe Merck VP for Global Market Access & Pricing Strategic Planning Marco Rauland examines the trend of collaboration between European countries looking to pool their resources on HTA, procurement, pricing, and reimbursement. Rauland compares the five most advanced such collaboration agreements currently active in Europe and the challenges and opportunities inherent…

USA Rare disease – defined in the US as a disease with a maximum patient population of 200,000 – is perhaps the most salient issue at the nexus of innovation, access, and affordability in the country.   As FDA CDER director Dr Janet Woodcock indicates, “rare diseases have been rising as…

USA With a series of reorganization initiatives, new leaders at the helm and exciting acquisitions, Novartis Oncology has undergone a significant business transformation in the past few years, and if the business unit’s 2019 performance is anything to go by, the efforts have paid off, with net sales reaching USD 14.4…

Switzerland Innosuisse CEO Annalise Eggimann presents the organisation’s renewed mandate as the main Swiss innovation promotion agency, how Innosuisse serves Switzerland’s vast array of SMEs, and why the country needs to guard against complacency to stay ahead of the competition on innovation.   A successful culture needs to guard against complacency.…

Global During the FT Global Pharmaceutical and Biotechnology Conference earlier this month, three industry leaders spoke about innovative reimbursement models like ‘pay-for-performance’ agreements and the implementation challenges of such initiatives. The session was moderated by FT reporter Donato Mancini and saw the participation of Novartis Oncology president Dr Susanne Schaffert; bluebird…

Japan Founded by Toyoji Naito in December 1941, in just under 80 years, Eisai has become a leading global biopharma player, with pharmaceutical revenues of USD 5.4 billion in 2019.   The company’s central philosophy of human health care (hhc) was introduced in 1992 by current director, representative corporate officer and…

USA Joe Lewis outlines the key concerns of Deloitte’s pharma clients around manufacturing and supply chain operations in the wake of the COVID-19 pandemic, how companies can come out of the crisis stronger, and highlights some of the major issues surrounding vaccine allocation and deployment.   One of the most common…

South Africa South African firm Aspen has inked a deal with Johnson & Johnson for the technical transfer and proposed commercial manufacture of their COVID-19 vaccine candidate, Ad26.COV2-S, boosting the company’s share price as well as its global profile.   Aspen is best known internationally for bringing generic antiretrovirals for HIV to…

USA After five years with Takeda heading up the Japan-headquartered pharma company’s US business, following the organization’s 2019 USD 62 billion acquisition of US rare disease player Shire, Ramona Sequeira was appointed president of global portfolio commercialization and a member of Takeda’s global executive team in April 2020. In conversation with…

Europe With upcoming EU regulation poised to have a massive impact on ethical regulations around AI in Europe, Bayer Head of Digital Transformation Saskia Steinacker argues that the time is now for pharma executives to start preparing themselves and their teams for the future.   “We are in Healthcare. We are…