The FDA has issued an expedited process for making COVID-19-related guidance documents to the public, which will allow rapid dissemination of essential agency recommendations and policies related to COVID-19.
To address the rapidly evolving COVID-19 outbreak, the FDA has announced an emergency investigational new drug (IND) application program that allows healthcare providers to use plasma from convalescing COVID-19 patients to treat patients in the U.S. with serious or immediately life-threatening COVID-19 infections.
In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities and goals. The Centre for Innovation in Regulatory Science (CIRS) and Sanofi partner on a study to evaluate their progress to date. The common […]
“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” Marie Curie The Coronavirus (COVID-19) pandemic has taken the world by storm with over 380K+ cases confirmed worldwide and 16K+ deaths as of this writing.1 Although the word “pandemic” […]
As the World Health Organization (WHO) reports that one third of the world’s population does not have timely access to the healthcare products they require, the efficient, predictable and speedy assessment and introduction of quality new medicines and vaccines to underserved patient populations continues to be a priority for the whole healthcare community. (1) A […]
As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings, and highlight current trials for treatment and vaccines. The novel coronavirus, first detected in Wuhan City, Hubei Province, China, has now been detected in 50 locations worldwide, […]
Understand the key drivers and trends of Q4 2019 biopharma business development activities, and get a preview of what’s in store for Q1 2020. Total disclosed biopharma mergers and acquisitions (M&A) value increased in the fourth quarter of 2019. Disclosed deal value of the top 10 biopharma M&As increased by 47% to $24.9 billion […]
Crowned by a potential cure for severe hemophilia A, which could become the most expensive drug ever, a new list of 11 medicines expected to generate $1 billion-plus in annual sales by the end of 2024 or earlier throws into stark relief the growing tension between medical innovation and society’s ability to pay for it. […]
Epizyme’s first-in-class EZH2 (enhancer of zeste homolog 2) inhibitor Tazverik (tazemetostat) has become the first therapy to be made available in the U.S. for the treatment of epithelioid sarcoma (ES), a rare soft tissue tumor with a significant unmet need.1,2,3 The drug was granted accelerated approval in January 2020 for the treatment of patients aged […]
Access the world’s leading research and late-breaking news on this rapidly evolving health emergency. A global health emergency can occur without warning, as we are currently experiencing with the rapidly-spreading coronavirus outbreak. As scientists attempt to develop vaccines and treatments as quickly as possible to meet the increasing needs of those affected, medical researchers and […]