Tagged with FDA

USA 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 Committee’s meeting on November 6 2020, what it means for that Aducanumab, and the impact on next-generation AD treatments.   November 6 could prove to be…

USA 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 Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…

USA 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 COVID-19 crisis, at what stage of development diagnostics and therapeutics for the virus are, and the pandemic’s long-term effects – both…

USA 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 as representatives of patient groups, health insurance providers, and firms operating in the US on what they consider the most pressing issues facing US healthcare.…

India A recent IQVIA report highlights the increasing importance of Indian firms to the USA’s burgeoning generic pharmaceuticals market.   Now accounting for over 90 percent of all prescriptions dispensed in the USA, generic drugs play a vital role within US healthcare and have come a long way since their use…

Global With clinical trials having become extremely expensive to conduct, industry buzz around the potential of data and artificial intelligence (AI) to allay these costs has grown. However, experts are split as to the true potential of digital tools to reduce clinical development outlay and provide better patient outcomes in the…

Japan 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 bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety…

Global To celebrate International Women’s Day 2020, PharmaBoardroom brings you insights from some of the most inspirational female industry leaders we have had the privilege of talking to over the past 12 months.   Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER), US FDA     Science really can…

USA Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). Approvals of products such as vaccines and gene therapies by the Center for Biologics Evaluation and Research (CBER) are not included in this drug count. Made with…

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…

India Below is a selection of the top stories in Indian pharma from recent months, ranging from efforts to counter the coronavirus, to regulatory reform, the spike in USFDA warning letters to Indian pharma manufacturers, promising export markets, and the growth of the Indian domestic market.   Repurposing HIV drugs to…

India 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 expansion into the Australia and New Zealand markets.   We see ourselves as a company that has great capabilities and is investing big time…