Global 2023 was a tumultuous year for the pharma industry, with much wailing and gnashing of teeth from executives over the Inflation Reduction Act in the US as well as updated EU pharma legislation in Europe. Those companies producing COVID-19 vaccines and therapeutics saw revenues return to normal levels while others…

USA Nominated by President Joe Biden, the National Institutes of Health’s (NIH) new director Monica M. Bertagnolli took the reins of the world’s largest public funder of biomedical research earlier this month. With a clear focus on improving access and clinical trial diversity, Bertagnolli’s priorities for the role appear to align…

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 Dr Vivienne Marshall, senior director of the Center for Advanced Therapies at the South Texas Blood & Tissue Center, part of BioBridge Global, outlines some of the major barriers to wider adoption of cell and gene therapies: complexity, variability, and the lack of robust standards. Dr Marshall also highlights the…

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.…

Global The global contract research organization (CRO) market is estimated to be worth USD 76.6 billion in 2023 and is projected to reach USD 127.3 billion by 2028, growing at a CAGR of 10.7% from 2023 to 2028. Much of this growth is due to the need for novel clinical trial…

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 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 the company since its botched acquisition of cancer blood test maker Grail, Thaysen will have to confront the company’s legal tangles with…

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…