Tagged with USA

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Global Well-informed and data-driven healthcare decision making has never been more important. Healthcare systems across the world – in both developed and developing contexts – are grappling with the challenge of providing quality treatments and services to patients while ensuring that their money is well spent. At the forefront of helping…

Global The speed with which Pfizer-BioNTech and Moderna’s COVID-19 vaccines were brought forward may have made the mRNA technology behind them appear novel. In fact, the pioneers whose discoveries enabled the creation of these vaccines, recent Nobel prize winners Katalin Karikó and Drew Weissman, had been working on the mRNA and…

USA The US Inflation Reduction Act (IRA) passed last year by the Biden administration and hotly contested by the innovative pharma industry, has started to look more like a reality since the first ten drugs subject to price negotiations under the IRA were announced in August. The negotiated prices will not…

Global After a 12-year stint at Sanofi, Bill Sibold is leaving Big Pharma to join the Pennsylvania-based biotech Madrigal Pharmaceuticals as CEO. Sibold, no stranger to ground-breaking launches, having brought the blockbuster Dupixent to market, will be coming onboard just ahead of what looks to be a pivotal moment for Madrigal.…

USA Having become one of the 20 youngest US billionaires as founder and CEO of disruptive biotech firm Roivant Sciences, Vivek Ramaswamy has now set his sights on becoming his country’s president. A long-term critic of how ESG criteria are used in corporate decision-making, Ramaswamy has since gone even further to…

USA The subject of intense industry criticism from the likes of lobby groups, Big Pharma, and biotech alike, the Inflation Reduction Act (IRA) subjects certain drugs to price negotiations directly with industry sponsors in the US for the first time. Ten initial drugs – which accounted for over USD 45 billion…

USA Illumina’s newly appointed CEO, Jacob Thaysen, will take the reins of the gene sequencing giant at the end of September. Falling heir to the difficulties that have plagued Illumina since its botched acquisition of cancer blood test maker Grail, Thaysen will have to confront the company’s legal tangles with the…

USA Biotech and life sciences companies have a habit of clustering together, creating shared ecosystems to drive innovation. For going on 12 years Johnson & Johnson Innovation (JLABS), has been supporting this strength in numbers philosophy, finding, funding and incubating promising startups under a scheme of open innovation in its shared…

Global Amgen has forged a solid position as one of the world’s largest independent biotechnology companies. With a market capitalisation of some USD 130 billion and 27 approved medicines, the US-based firm has come a long way from its original biotech upstart status in 1980. Nonetheless, Amgen has faced obstacles in…

USA With office occupation rates on the slide and the life sciences industry’s demand for lab space on the rise, the repurposing of existing offices into medical laboratories has become an important new asset class, writes Liz Chen, a lab planner at HGA Life Science + Advanced Technology Group’s San Diego…

Global The Alliance for Regenerative Medicine (ARM) brands itself as the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. ARM’s latest sector snapshot details the cell and gene therapy approvals list for 2022, as well as the number of…