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…
Tagged with FDA
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…
Janet Woodcock – Director, Center for Drug Evaluation and…
In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA)…
Indian Pharma Roundup: January 2020
Below is a selection of the top stories in Indian pharma from recent months, ranging from efforts to counter the coronavirus, to regulatory reform,…
Biocon’s New Facility & Expansion in APAC
Biocon, the first Indian company to have a biosimilar drug approved in the US, is taking another step forward with a new manufacturing facility and an…
FDA Drugs Approved in 2019
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…
US FDA’s Efforts to Advance the Development of Gene Therapy
Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research, outlines how the organization is attempting to further…
