Opinion Monica Weldon, CEO and president of Bridge the Gap – SYNGAP Education and Research Foundation, shares her recent experience at the US Drug Law and Regulation course in Washington, DC and expands on the role that patient associations can play in the drug development process.   In today’s environment of…

USA Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research, outlines how the organization is attempting to further promote the advancement of cutting edge cell and gene therapies in the US and beyond.   To keep pace with the remarkable and continuing growth of gene therapy, FDA’s…

USA The AAM’s Chip Davis examines the roadblocks to greater adoption of biosimilar drugs in the USA, and why they need to be removed to potentially save billions of dollars and increase patient access to lifesaving medications.     In a nutshell: competition brings prices down across the board Biologic drugs…

USA AstraZeneca’s Rick R. Suarez looks at workable solutions to the challenges facing healthcare in the US and why inter-stakeholder collaboration, rather than finger-pointing, is the only way forward.   Discussion and debate related to cost and quality in healthcare has never been more pronounced or more contentious, whether focusing on…

USA Carla Smith looks at the various cybersecurity risks that exist across the US healthcare continuum and the steps that executive leadership can take to combat this threat.   Keeping patient data safe and secure remains a challenge. Thanks to a 9-year review of experiences in the United States, we know…

USA The US drug-price watchdog, The Institute for Clinical & Economic Review (ICER) recently issued a “Report on Unsupported Price Increases,” picking a number of innovative medicines that it says have seen price hikes without sufficient substantiation. While the study made the headlines, Certara’s Ulrich Neumann calls for some scepticism and…

Opinion Sophia Ononye outlines the history of cannabis as a medicine in the US and, following the first FDA approval of a cannabis-derived drug product in 2018, the highly promising landscape for further approvals.   The landscape for approved CBD products is highly promising and will undoubtedly lead to additional FDA…

Opinion The AAM’s Chip Davis tackles the issue of abandonment within US healthcare and proposes three measures to boost competition, thereby lowering drug prices and reducing abandonment rates.   Generic and biosimilar prescription drugs manufactured by member companies of the Association for Accessible Medicines (AAM) play an integral role in the…

USA Although Boston and California may be more internationally renowned as biotech hubs, New York is fast catching up. Thanks in large part to its strong scientific and business infrastructure and easy access to capital, growing numbers of early-stage biotechs are choosing to base their operations in New York and list…

USA In the face of rising costs in American healthcare, Carla Smith outlines five ways in which the US can improve the financial sustainability of its healthcare system.   Let’s take advantage of systems-level expertise and change our reality for the better In the United States, 18 percent of the gross…

Cell & Gene Therapy Medicare, a national health insurance program in the United States covering Americans aged 65 and older as well as younger people with disabilities, has recently announced it will be increasing reimbursement rates and expanding coverage for cell and gene therapy treatments, good news for cancer patients and pharma companies Gilead…

USA PhRMA’s Anne McDonald Pritchett PhD highlights the remarkable development of cell and gene therapies in recent years and the three ways in which the US healthcare system can better accommodate them: creating manufacturing systems that take treatment timelines into account, a health system that values treatments based on patient outcomes,…