Canada Some of the top stories coming out of Canadian healthcare and life sciences, including a new GSK flu vaccine deal, Amylyx Pharmaceuticals’ first approval for an ALS drug, and the Public Health Agency of Canada’s recent smallpox contracts with Chimerix and Bavarian Nordic.   GSK flu vaccine deal renewal (Reuters)…

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…

Brazil The latest from Brazilian Pharma, including the approval of home grown cannabis for medical use, Cellera Farma’s partnership with Ferring, a considerable increase in demand for oncology drugs, and a dire diabetes prediction.   Brazil court approves home grown cannabis for medical use (ABC News) A top court in Brazil…

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…

North America In April, the Canadian Ministry of Health announced the government would not be proceeding with certain proposed amendments to the Patented Medicines Regulations which govern the Patented Medicine Prices Review Board (PMPRB)—amendments related to new excessive price factors. The decision, well-received by Innovative Medicines Canada, came after these controversial economic…

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…