Global AstraZeneca’s CEO Pascal Soriot warns that the new US legislation controlling drug prices would reduce innovators’ capacity to recover drug development investments and therefore discourage innovation, especially for drugs with smaller patient pools. In a Reuters interview last week Soriot said the law recently passed in the United States that would…

USA While patient groups view the United States’ new Inflation Reduction Act as a positive move towards capping out-of-pocket drug costs for older Americans, the innovative pharma industry, after aggressively lobbying against it, still argues that the new legislation will hamper drug development. [The new law] is a significant step in…

USA Pharma companies have become vocal about social issues in recent years, championing access and affordability and launching initiatives to address diversity, but in the weeks since the United States’ Supreme Court’s overturn of the Roe v. Wade ruling on abortion the industry’s reaction has been far from consistent. While certain…

USA Monica Weldon draws on her own experience as a rare disease patient advocacy group CEO to outline how such groups can work collaboratively with other stakeholders in drug development to better target funding and create a more patient-centric drug development process that ultimately gets better drugs to rare disease patients…

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…

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…