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…

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…

USA David H. Crean, managing director for Objective Capital Partners, provides insights on US innovation and long term sustainability.   The life sciences industry within the United States makes significant contributions to both America’s health and economy and is a leader in R&D and innovation based on numerous proxies including patents received,…

USA In his latest piece on Alzheimer’s Disease (AD) drug Aducanumab’s winding journey to market, Dr Neil Cashman looks forward to the US FDA Advisory Committee’s meeting on November 6 2020, what it means for that Aducanumab, and the impact on next-generation AD treatments.   November 6 could prove to be…

USA Market access and pricing expert Barbara Jaszewski outlines the issues inherent in the USA importing drugs from Canada and why such proposals retain political capital despite massive and proven flaws.   Drug importation is a curious “zombie” proposal that never seems to die Donald Trump and Bernie Sanders have one…

USA Stephen J. Ubl, president and CEO of PhRMA, outlines the unprecedented collaboration and speed with which the biopharmaceutical industry has responded to the COVID-19 pandemic and the solutions that PhRMA is proposing to lower patient costs while protecting innovation and access.   We know that our innovation and our collaboration…

USA Dr Philipp Diesinger and Dr Gabriell Máté outline why a data-driven approach can help optimise patient copay assistance programs in the US across a wide range of patient groups, increasing access and driving down costs in the process.   2020 has been an exceptionally turbulent year – especially for the…

USA The US heads for three leading international mid-cap innovators – Japanese firms Eisai and Kyowa Kirin and Danish outfit Lundbeck – explain their vital role leading operations in the world’s most innovative and lucrative pharma market, translating global cultures to a US reality, and the challenges of attracting and retaining…

USA Certara’s Ulrich Neumann looks at the challenges that payment models for cell and gene therapy (CGT) have faced, the multiple models now under development, and why an open and collaborative approach among US healthcare stakeholders is needed if the significant legal and practical barriers are to be overcome.   The…

Switzerland The USA is now Switzerland’s biggest export market and in 2019 Switzerland exported more to the US than to France, Italy, the UK and Austria combined and twice as much as Brazil, Russia, India and China combined. However, as Martin Naville of the American Chamber of Commerce in Switzerland recently…

USA In the aftermath of the fiery first presidential debate between incumbent Donald Trump and Democratic Party rival Joe Biden, we round up the latest on how the latest developments in US politics stand to affect pharma and healthcare. Featured are the two candidates’ proposals for drug pricing reform and Trump’s…