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…

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 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…

USA Ramona Sequeira, recently appointed chair of the PhRMA board of directors and president of Takeda’s US Business Unit and Global Portfolio Commercialization, gives her take on how the biopharma industry can do more to address the systemic inequities in US healthcare, including community-focused grant programs, clinical trial diversity initiatives, and…

USA In the wake of Access! 2022, the Association for Accessible Medicines (AAM)’s first in-person annual summit in two years, AAM President and CEO Dan Leonard gives his five takeaways from what he describes as a “rich, complex, and provocative” conference.   The generic and biosimilar supply chains continue to demonstrate…

USA Ramona Sequeira of Takeda has taken the reins as chair of US industry lobby group PhRMA’s Board of Directors, becoming the first ever woman to hold the role. She succeeds Lilly Chairman and CEO David Ricks at a juncture when the industry is under pressure from proposed US pricing reforms…

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…

USA A roundup of the latest news from US life sciences and healthcare, including sweeping healthcare reform in the state of California; how revolutionary billionaire Mark Cuban’s newly launched affordable online pharmacy Cost Plus Drug Co. can be; DHL’s USD 400 million expansion of its pharmaceutical and medical device supply chain…

Global Bernie Zeiher, chief medical officer (CMO) of Astellas explains why the ‘patient-defined value’ of medicines is crucial to developing therapies that truly address patients’ unmet medical needs. Zeiher outlines some of Astellas’ work with patient advocacy groups to generate these insights, why a new era of real-world data (RWD) generation…