USA Drawing on her experience as rare disease patient advocacy group SYNGAP1 Foundation’s founder and former president, Monica Weldon argues for the need to standardize genomic testing practices, warns against the possible ethical implications of individualized medicine, and makes a cause for a more holistic approach within rare disease communities.  …

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…

Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…

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…

Brazil The latest pharma news from Brazil, including the partnership between Biophytis and Innovation Solutions Pharma; Merck’s 100 years in Brazil; Eurofarma’s USD 100 million biotech investment, and GSK’s green light from ANVISA.   Biophytis and Innovation Solutions Pharma Sign a Partnership Agreement to Accelerate Market Access for Sarconeos in Brazil…

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)…