Tagged with USA

Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.   The need to optimize drug development and facilitate faster access for patients has focused discussions…

Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024.   Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…

Global Recently appointed ISPOR President Eberechukwu Onukwugha, PhD, lays out her inclusive vision for the organisation’s future, championing health economic and outcomes research excellence and innovation that works for all. The original version of this article featured in the July/August edition of ISPOR’s Value & Outcomes Spotlight magazine.   As I…

USA AbbVie, for only the second time in its history, has a new CEO. Having been led by Richard A. Gonzalez since its inception in 2013, the organization has named former president and chief operating officer Robert A. Michael as its new leader. As he takes on the role this month,…

USA The Promising Pathways Act 2.0 is a newly proposed bill that aims to expedite and streamline approval pathways for rare disease therapies in the US. The Act is, however, facing a number of challenges in terms of implementation. The sponsors of these niche therapies tend to be small and medium-sized…

Global Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States…

USA A public health initiative said to have saved over 25 million lives, the US President’s Emergency Plan for AIDS Relief (PEPFAR) has had an enormous impact on the fight against HIV/AIDS through providing HIV treatment, prevention, and education. Since its inception in 2003 PEPFAR has largely enjoyed bipartisan support within…

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…

Global The US National Institutes of Health (NIH) is the largest public investor in HIV/AIDS research globally. This means that, as Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy & Infectious Diseases (NIAID) Dr Carl Dieffenbach oversees a global HIV/AIDS research portfolio of more than…

USA Since founding the HIV advocacy group Prevention Access Campaign (PAC) and launching its Undetectable=Untransmittable (U=U) campaign in 2016, Bruce Richman has been focused on raising awareness around a revolutionary but widely unknown fact: people living with HIV who are on treatment and have an undetectable viral load cannot sexually transmit…

USA In the latest government-driven initiative to tackle drug prices in the US after the Inflation Reduction Act (IRA), California plans to cut drug prices by buying opioid overdose reversal drug naloxone directly from its generics manufacturer and distributing it under its own CalRx initiative.   California will continue to be…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…