USA Certara’s Ulrich Neumann examines some of the major US market access trends of the past few years, including the innovative financing models required for novel therapies, why cost effectiveness considerations are on the rise, and the impact of the drug policy environment on payer sentiments.   The US reimbursement landscape…

USA Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain…

Norway Photodynamic therapy (PDT) firm Photocure is probably Norway’s most significant recent international healthcare success story. CEO Dan Schneider explains how the company was able to action a more effective global commercial strategy and carve out a niche in the relatively uncrowded oncology drug-device combination market.   Despite its technology being…

USA A Tale of Two Americas The US stands as the biopharma innovation champion of the world, a global leader on nearly all R&D indices related to investment and innovation. It also holds a tremendous amount of clout, representing half the world’s healthcare market, and the US healthcare industry itself is…

USA AAM President Dan Leonard highlights the findings of the association’s most recent report and re-states the value proposition of generic and biosimilar drugs in the USA.   AAM’s 2020 access and savings report documenting the savings generated by generic prescription drugs once again trumpets the value proposition of generic and…

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,…

Canada Clint Sharples, CEO of Heritage Cannabis, gives a potted history of the medical cannabis industry in Canada, its current legal status, provincial variations in patient registrations, financial performance, the impact of COVID-19, and where the field is headed for the future.   The cannabis plant has been used as a…

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…