Tagged with USA

USA In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world’s gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and…

Coronavirus The 2019 Wuhan coronavirus outbreak has seen a surge in demand for protective masks as publics across the world seek to protect themselves from infection. Manufacturers of the masks have seen their stocks boom, but supply is outstripping demand and hoarding practices may leave healthcare professionals on the frontline of…

USA In 2019, several drug companies testified to the US Senate Finance Committee on medicine price hikes with a narrative of discounts given to health insurance companies and pharmacists, but not then passed onto consumers. In a recent conversation with PharmaBoardroom, Matt Eyles, president & CEO of the Association of Healthcare…

USA Takeda’s Jessica S. Scott examines the steps already being taken to bring greater patient engagement to drug development and the regulatory decision-making process in the USA; as well as what more needs to be done in this crucial area.   Steps Taken by FDA Under the Food and Drug Administration…

USA The Association for Accessible Medicines’ Chip Davis outlines the ways in which the US Medicare programme needs updating in order to promote generic and biosimilar competition and therefore increase patient access to more affordable medicines.   In this election year I hope that the candidates will lay out their solutions…

USA In 2019 big pharma companies prioritised shareholder payouts and dividends, with the eight biggest US pharma companies topping $31 billion in stock buybacks and the same amount in dividends. Revenues were not necessarily consistent with dividend and buyback amounts, and some critics argue that payouts should be lessened in favour…

USA David Crean summarises the mood at the recent J.P. Morgan Healthcare Conference 2020 in San Francisco, noting a more subdued atmosphere than previous years, with reduced attendances and no big M&A announcements. Crean does, however, underline the importance of the Conference for industry networking and highlights some of the biopharma…

USA The AAM’s Chip Davis gives an account of his agenda for 2020, how the association is driving policy in a complex healthcare environment of multiple public and private actors and offers insight as to why there is great room for improvement in the uptake of biosimilar drugs.   The question,…

USA Eurasia Group’s Aditya Bhattacharji examines the stalling of healthcare reforms in the US and what changes to US healthcare it is realistic to expect.   Pharma is unlikely to be frog-marched by sweeping federal initiatives, but more incremental changes are likely With anti-pharma sentiment raging at the end of 2018,…

USA Matt Eyles, president and CEO of the Association of Healthcare Insurance Providers (AHIP) outlines how the US health insurance landscape has evolved in the last ten years, counters some of the pharmaceutical industry’s criticisms of insurance firms, and outlines why greater affordability of healthcare in the US will benefit all…

USA In 2019, the US FDA’s Center for Drug Evaluation and Research approved 42 novel drugs, down from 59 drugs approved in 2018. Novartis had four drugs approved, the highest number from any single pharma company. 16 of the 42, or 38 per cent, received orphan drug designation. This listing does…

Opinion The AAM’s Chip Davis looks back on 35 years of healthcare system savings from generic pharmaceuticals in the US, and the peril the generics industry faces from the Lower Health Care Costs Act.   A key provision of our generic pharmaceutical architecture is in jeopardy. The “180-day exclusivity” is the…