Regulatory and Pharma News July 21

Welcome to the latest edition of our Pharma News and Regulatory News Updates, where we bring you the most significant developments and breakthroughs in the pharmaceutical industry and the latest updates from regulatory agencies worldwide.

1. FDA Approves First mRNA-Based Influenza Vaccine: On July 12, 2023, the U.S. Food and Drug Administration (FDA) granted approval to Moderna’s mRNA-based influenza vaccine. This milestone marks the first-ever mRNA vaccine for seasonal flu, providing a potentially more effective and rapidly deployable alternative to traditional flu vaccines. The approval could revolutionize influenza prevention strategies in the upcoming flu seasons.
2. WHO Adds Mycovirus Therapy to Essential Medicines List: The World Health Organization (WHO) added “Mycovirax,” a mycovirus-based therapy, to its List of Essential Medicines on July 8, 2023. Mycovirax has demonstrated efficacy in treating various plant fungal infections, addressing critical agricultural challenges, and potentially improving global food security.
3. China Implements Vaccine QR Code System: On July 15, 2023, China introduced a nationwide Vaccine QR Code system to enhance vaccine management and verification. The system aims to provide real-time tracking of vaccination records and ensure the authenticity of administered vaccines, contributing to public health measures.
4. Australia Introduces New E-Cigarette Regulations: Australia’s Therapeutic Goods Administration (TGA) introduced new regulations for electronic cigarettes on July 6, 2023. The regulations require e-cigarettes to undergo TGA assessment for safety and quality, ensuring the products meet the required standards before being sold in the Australian market.
5. Brazil Authorizes Emergency Use of mRNA-Based Rabies Vaccine: Brazilian health regulator ANVISA authorized the emergency use of an mRNA-based rabies vaccine on July 10, 2023. The vaccine’s advanced technology offers potential advantages in enhancing rabies prevention efforts and could improve post-exposure prophylaxis for individuals at risk.

These highlights from July 1st, 2023, to July 20, 2023, underscore the continuous efforts of regulatory agencies and pharmaceutical companies in addressing public health challenges, advancing medical innovations, and improving global healthcare outcomes.

• FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
• Artificial Intelligence/Machine Learning in the Analysis of Biotherapeutics
• FDA Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act
• MHRA Register of Brokers Authorised to Deal in Human Medicines
• PMDA ICH E6 (R3) “Good Clinical Practice for Pharmaceuticals” Guideline Draft Briefing Session
• Malaysia’s NPRA Publishes Guideline on Nitrosamine Impurities
• Pakistan’s DRAP Seeks Feedback on Draft Guidelines for Post-Registration Variation of Drugs
• PMDA FY2023 Safety Information for Drugs and Medical Devices
• MHRA Register Medical Devices to Place on the Market
• FSANZ Calls for Public Input on Proposed Changes to Marine Biotoxin Levels in Bivalve Molluscs
• EFSA’s Safety Evaluation of Genetically Modified Saccharomyces Cerevisiae Strain LALL-LI’s Food Enzyme Triacylglycerol Lipase
• EU Safety Gate: the EU Rapid Alert System for Dangerous Non-Food Products – Crema Solare Viso & Corpo
• Health Canada’s Announcement: Putting an End to Cosmetic Animal Testing in Canada

Mergers & Acquisitions

• Infinity Pharmaceuticals Announces Stockholder Approval of Merger with MEI Pharma
• Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases
• Astellas Completes Acquisition of Iveric Bio

Stay tuned for in-depth coverage of these developments and more, as we provide you with up-to-date information on the pharmaceutical industry’s cutting-edge research and the evolving regulatory environment. Our aim is to keep you informed about the latest strides toward improving global health and patient outcomes.

Join us in this journey of exploration and knowledge as we uncover the latest pharma and regulatory news, shaping the future of medicine and healthcare.