The Long Read: Innovation, Access & Affordability in the 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…
Tagged with FDA
Top 10 PharmaBoardroom Interviews of 2020
2020 was a challenging year globally, but one in which the importance of the healthcare and life sciences sector was underlined like never before.…
Rare Disease Strategies in the Booming US Market
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…
Aducanumab edges closer to Potential Approval: Next up, the…
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…
Peter Marks – Director, Center for Biologics Evaluation and…
Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights…
The FDA’s COVID-19 Shakeup
In a recent virtual town hall meeting hosted by BIO, two key leaders from the US FDA laid out how their organisation has adjusted in the wake of the…
Hot Topics in US Healthcare & Pharma
So far in 2020 PharmaBoardroom has conducted interviews with several key stakeholders in US healthcare. We have heard from leaders the US FDA, as well…
Indian Generics in the USA: Destined for More Success?
A recent IQVIA report highlights the increasing importance of Indian firms to the USA’s burgeoning generic pharmaceuticals market. Now…
Data – The Catch-All Solution for Costly Clinical Trials?
With clinical trials having become extremely expensive to conduct, industry buzz around the potential of data and artificial intelligence (AI) to…
New PMDA Head Yasuhiro Fujiwara Sets Out Top Priorities for…
In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory…
PharmaBoardroom’s Women to Watch 2020
To celebrate International Women’s Day 2020, PharmaBoardroom brings you insights from some of the most inspirational female industry leaders we have…
US FDA New Drug Approvals 2019 Snapshot
Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and…
