Tagged with EG

China Dr George Chen explores D3 Bio’s strategic approach to drug development, its ambition to launch two cancer therapies in the US within five years, and the critical role of partnerships and funding in achieving these goals. Reflecting on this journey, Dr. Chen emphasizes, “It’s a journey to realize a dream…

Mexico Stendhal Pharma operates with an “unlimited pipeline” approach by forming strategic alliances with global pharmaceutical companies that lack a presence in Latin America. Rodrigo Ruiz Mingramm explains how, as companies reconsider their direct presence in Latin America due to political and socio-economic uncertainties, Stendhal’s model is becoming more appealing, and…

Global Originally seen as occasional service providers for the pharma industry, contract development and manufacturing organisations (CDMOs) have become vital strategic partners. Helping pharma and biotech companies advance their therapies through their outsourced services, CDMOs have demonstrated their ability to respond to the industry’s shifting priorities as well as its pre-…

Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…

Europe Vikas Krishan, chief digital business officer at the global data and digital engineering solutions firm Altimetrik, outlines the implications of the European Union’s forthcoming AI Act for the pharma industry and urges for the need to adopt a proactive approach in evaluating AI roadmaps and governance.   The pharmaceutical industry’s…

Mexico Wiener Lab is a leader in diagnostics, with a strong focus on clinical chemistry, immunology, coagulation, and molecular biology. As Héctor Barillas Soto explains, the company has a significant presence in Mexico and Latin America and specializes in providing advanced diagnostic solutions for both small and large laboratories. Barillas Soto…

China Drawing on a wealth of Big Pharma experience, Jenny Zheng now leads China operations for Illumina, a global leader in genomics, specialising in DNA sequencing technology that drives innovation in healthcare, research, and personalised medicine. Illumina continues to see China as a crucial part of its global strategy due to…

Europe Contributing to the August 2024 edition of DIA’s Global Forum magazine, Magda Chlebus from the EFPIA, Steffen Thirstrup and Alberto Ganan Jimenez from the EMA, Katharina Nothelfer of AiCuris Anti-infective Cures, Pedro Franco of Merck Serono, Annette Bakker of CTF Europe, Tim Chesworth of AstraZeneca, Jeevan Virk of Novartis, Virginie…

Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024.   Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority responsible for drugs, biologicals, and medical devices in Iraq is the Ministry of Health “MoH”. There is a dedicated body within the MoH known as the Iraq Drug Regulatory Authority…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? In Iraq, it is not always explicitly required that the clinical trials be conducted locally for marketing approval. However, if local data are requested, companies must comply with these requirements. Local clinical…

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? In Iraq, the authorization process for marketing new drugs, biologics, medical devices, over-the-counter “OTC” medications, and other medicinal products is managed by Iraq Drug Regulatory Authority “IDRA” at Ministry…