Tagged with USA,

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…

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…

Global In June 2021, as part of a broader restructuring, Merck (MSD globally) spun off its women’s health, legacy products, and biosimilars businesses. The new company formed, Organon, is positioning itself as “the only player of its size (USD 6.3 billion in revenues for 2021, 9,000 employees) focused on women’s health…

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 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 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…

Global Writing in the February edition of DIA’s Global Forum magazine, Candice Del Rio of Curavit Clinical Research examines the applicability of decentralised clinical trials in oncology research, and their positive impact on both decreasing patient dropout rates and increasing patient engagement. Oncology represents the largest research area globally, with 6.5 percent…

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…