USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…
Legal Handbook Preclinical and clinical trial requirements in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119. 1. Are clinical trials required to be conducted locally as a condition…
India Suresh Pattathil wears two hats within India’s vast pharma ecosystem. Not only is he responsible for managing AbbVie India as its Managing Director and GM, he also advocates for broader pharma interests as president of the Organization of Pharmaceutical Producers of India (OPPI). He speaks about India’s goal of fostering…
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,…
Morocco From Morocco to the world, ABA Technology is an industrialisation, integration, and software development service partner providing solutions to private and public sector stakeholders in four continents. Vice President Amer Benouda lays out some of the company’s key success stories thus far; its future international expansion plans; and its mission…
Global Merck’s Kaushal Kishore attempts to illustrate why pharma companies have struggled to crack what he calls “the Gross to Net (GtN) code.” He outlines the maturity journey for a pharma commercial and pricing organisation which can lead to maturity on the GtN topic, and highlights a successful example that can…
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 Patents can be an excellent way to demonstrate value, not only showing that a technology is protected but also how promising it can be when it eventually comes to market. Here, William Mansfield of LexisNexis® Intellectual Property Solutions outlines how ‘patent analytics’ can help identify pharma’s top performers today as…
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…
Hong Kong Insighta, formed this year as a 50/50 joint venture between genomics-focused outfit Prenetics and one of the city’s most feted scientific sons, Professor Dennis Lo, is aiming to change the face of cancer care via widespread early detection. While early detection is widely recognised as crucial to enhancing cancer…
Europe The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a new initiative made up of industry association the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), molecular diagnostics firms Exact Sciences and Guardant Health, sequencing platform provider Illumina, and drugmakers MSD and Novartis. Here, the coalition lays out its aims…
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…
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