USA In late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them. This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription…
Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…
India Mohal Sarabhai, managing director of Ambalal Sarabhai Enterprises Limited (ASE) on transforming his family’s failing century-old business and creating new companies beneath the ASE Holdings umbrella, including a joint venture with Co-Diagnostics, CoSara Diagnostics, that span areas from diagnostics to APIs. He highlights CoSara Diagnostics’ tuberculosis (TB) and human papillomavirus…
Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…
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…
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