Tagged with USA

USA US generics giant Mallinckrodt, which declared bankruptcy in 2020 after a stream of litigation regarding its role in the opioid epidemic and underpaying Medicaid rebates for its drug Acthar, has announced a new strategic plan and CEO as it emerges from its “restructuring process.”   Controversy on Controversy The USA’s…

USA As of July 1st, long-term Merck alumni, Chirfi Guindo, will be returning to the company to lead Human Health Marketing as chief marketing officer for Merck Human Health and will join the Merck Executive Team after almost 5 years at Biogen. Before the parenthesis at Biogen, where he served as…

USA After US life expectancy fell for a second consecutive year, FDA Commissioner, Dr Robert M. Califf, speaking at the recent 2022 Biotechnology Innovation Organization (BIO22) International Convention, discussed what he believes to be the leading cause of death in the United States. Commissioner Califf stated during a fireside chat at…

USA At its recent convention, the first live one in 3 years, the Biotechnology Innovation Organization (BIO) announced the Executive Committee directors for the 2022-2023 term, elected during the event that brought together global thought leaders for 4 days of interactive sessions. This is a critical time for our industry. Our…

Global How diverse is the biotech workforce? A recent report shows the industry has made progress in terms of diversity, equity, and inclusion (DEI) but still has a way to go. According to the third annual report measuring diversity, equity, and inclusion (DEI) in the biotechnology industry, produced by Coqual in…

Global David H. Crean, Managing General Partner for Equitos Venture Partners and Cardiff Advisory, highlights the latest trends and recommendations for business and corporate development transactions and capital financing of life sciences companies in 2022. We are currently experiencing economic headwinds, making it a challenging time for growth companies such as…

Global The COVID-19 pandemic brought the issue of access to medicines to the forefront. Not only did supply chain disruptions lead to initiatives designed to make sure essential medicines reach patients, but the pandemic also served to underline a number of pre-existing access inequalities. Several of PharmaBoardroom’s recent interviewees have discussed…

USA Longtime Director of the Center for Drug Evaluation and Research CDER, Janet Woodcock, will be changing roles at the US Food & Drug Administration (FDA) and moving away from drug regulating. It is still unclear what her new role will entail. Rob Califf, the new FDA commissioner recently announced in…

USA In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials. According to its Drug Trials Snapshots Report for 2019, of the clinical trials…

USA The pandemic revealed widespread pharmaceutical supply chain vulnerabilities in the United States, an issue the Biden administration has attempted to address partly through industry funding. The Chief Business Officer of Phlow, a company that has received federal government funding for manufacturing essential medicines in the US, spoke at the recent…

USA Stephen J. Ubl, President & CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) discusses the organisation’s initiatives to address health inequity in the US along with its opposition to the provisions in the Biden administration’s Build Back Better Act to lower costs and improve access. He also comments on…

USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…