USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…
USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…
Global One of the enduring conundrums around ground-breaking and potentially paradigm-shifting treatments such as CAR-T is the ever-thorny question of how fast to move them to market when the promise seems so great, but the evidence remains so patchy. So far, top tier regulators such as the US FDA and…
USA Almost ten months into his presidency, Joe Biden has announced his pick to lead the US Food and Drug Administration (FDA). If confirmed by the Senate, the nominee, Dr Robert Califf, would become commissioner for a second time after leading the agency for almost a year at the end of…
Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…
Saudi Arabia Clinical trials provide a pathway to innovation for clinicians and patients in countries like Saudi Arabia and form a key element of the country’s Vision 2030 national plan. As Saudi transitions away from oil towards becoming a knowledge-based economy, it is hoping to attract ever more international pharma companies to…
USA Writing in the May edition of DIA’s Global Forum magazine, Erica Lyons, Sarrit Kovacs, Matthew Kowalik, and Jessica Lee from the Division of Gastroenterology, Office of New Drugs, CDER at the US FDA look at how patient input is increasingly being utilised in new drug development, its importance in assessing…
Saudi Arabia In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the organisation’s strategic priorities. As part of the Authority’s 2018-2022 strategic plan, it has set out a number of goals, ranging from setting clearer objectives to strengthening its capabilities,…
Saudi Arabia Speaking exclusively to PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA), outlines the SFDA’s key priorities under its current strategic plan. He also touches on why domestic pharma and medtech manufacturing is important to the SFDA, pricing issues for innovative new therapies, and…
USA In 2020, the US FDA’s Center for Drug Evaluation & Research (CDER) approved 53 novel drugs, up from 48 in 2019, across a range of therapeutic areas, including the first treatments for COVID-19 patients. The FDA’s Center for Biologics Evaluation & Research (CBER) is charged with approving new biologic…
USA Hours after President Biden was inaugurated on Tuesday 19th January 2021, Dr Janet Woodcock was named as acting commissioner for the Food and Drugs Administration (FDA). “The FDA’s public health work is more critical than ever as we continue to fight this global pandemic… The American people can be certain…
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 investment and innovation. It also holds a tremendous amount of clout, representing half the world’s healthcare market, and the US healthcare industry itself is…
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