USA As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Louis Haynes takes a look at a watershed year for drug pricing in the planet’s most lucrative pharma market.   Drug development is inherently a risky business, but this will compound that risk further… to the point where now,…

Global Last year’s COP28 summit saw a host of pharma players touting their green credentials, as PharmaBoardroom’s Louis Haynes explores here. This is an extract from our Transformative 2023: Regional Pharma Trends report, available for free download now.   At the recent COP28 climate change conference in the UAE, industry bodies…

USA As the US Inflation Reduction Act (IRA) starts to become a reality, and both big pharma and biotech companies brace themselves for its more widespread impact, BIO names Washington fixture, rare disease advocate and entrepreneur John Crowley as its new CEO.   After waiting for a new leader for over…

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

Global AI is the buzzword du jour across all industries, but what is needed for it to truly make a difference in clinical trials? Writing in December 2023’s DIA Global Forum magazine, Lokavant’s Rohit Nambisan lays out the three essential characteristics for AI impact in clinical research, foregrounding the vital importance…

USA Eli Lilly has turned its numbers around and become the world’s most valuable pharma company, thanks to its type 2 diabetes and off-label use obesity drug tirzeptide, which generated no less than USD 1.4 billion in its first full quarter on the market. As the US firm prepares to launch…

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…