Tagged with P

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

Germany The biggest pharma industry and healthcare stories from Germany, including the country’s legalisation of cannabis; the MASH potential of Boehringer Ingelheim’s obesity candidate; Bayer’s further share price drop and expansion into the US; the antibody-drug conjugate (ADC) specialist Tubulis’ series B2 financing, and Novartis’ deal with biotech MorphoSys.   Germany’s…

India Regular contributor Brendan Shaw gives his informed take on how best international stakeholders can engage with India’s attempts to transform into a global pharma innovation powerhouse,   Our greatest ability as humans is not to change the world, but to change ourselves Mahatma Gandhi The secret to success in India…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, Scott P. Commins of the University of North Carolina School of Medicine, Jasmine Uchi of VeganMed, and Sachin A. Shah of the University of the Pacific address the use of animal-derived ingredients (ADIs) in pharma and outline a…

USA At the American trade association’s latest CEO & Investor Conference, the board chair of the Biotechnology Innovation Organization (BIO) Ted W. Love discussed US policies and speculated about the impact of the upcoming American election on the industry while affirming that biotech continues to thrive in spite of recent challenges.…

Switzerland The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.   Swiss industry welcomes agreement with India, pharma more cautious (Le…

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles   a. Pricing and impact of generic/biosimilar approval Currently there are no policies in place in this regard.   b. Clawback/Payback/Discounts/Rebates In Portugal, the main mechanism for cost-containment is the prior evaluation, regulated…

China The latest news from Chinese pharma, including progress on the US Senate bill targeting BGI and WuXi AppTec, a report on why drug research is slowing in the country, and why Chinese firms are targeting global deals to navigate the capital crunch.   US Senate bill targeting China’s BGI, WuXi…

India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials do not have to be conducted locally as a condition for marketing approval. This is not one of the prerequisite conditions for approval of the clinical trial protocol, which…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3.   2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question…