Verona Pharma’s Post

Industry news 📰 Congratulations to Verona Pharma on the FDA approval of Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. #copd #fdaapproval #lifesciencesnews #pharmanews #lifesciences

New FDA indication for Imfinzi

Reminder! The recommended deadline for 2023 drug reporting numbers for transfillers is July 31st! 📅📝 If you move oxygen from one container to another and are registered as a manufacturer, the FDA now requires you to submit your annual fills to stay compliant. Not sure if this applies to you? Learn more about CARES Act drug reporting: https://bit.ly/3RYZvY0! 🚀 #Transfilling #FDACompliance #DrugReporting

🌟FDA's Purple Book: Your Go-To Resource for Biologics and Biosimilars! 🌟 Are you a healthcare professional, industry stakeholder, or simply interested in the world of biologics? The FDA's Purple Book is here to provide you with comprehensive information on licensed biological products, including biosimilars. 🔍 Key Features: - Access detailed information about biologics approved by the FDA. - Explore patent information associated with licensed biological products. - Utilize the user-friendly interface to find what you need quickly and efficiently. 🛠️ How to Check Information: 1. Visit the Purple Book Website: [Purple Book Website](https://lnkd.in/dYH78p5U) 2. Search for Products: Use the search bar to enter the product name or active ingredient. 3. Explore Details: Click on the product to view approval dates, exclusivity, and patent information. 4. Utilize Filters: Narrow down your search using filters for more specific results. Whether you're looking for product names, approval dates, or exclusivity details, the Purple Book is your one-stop resource for all things biologics. 👉 Explore the Purple Book today: Purple Book Website (https://lnkd.in/dYH78p5U) #Biologics #Biosimilars #FDA #HealthcareInnovation #Pharmaceuticals #US #EU #research #kaust #gcc #middleeast #healthcare #pharma

📌 NEWS | Publication of two guidelines from the FDA and one from the EMA Two guidelines from the FDA were updated and one from the EMA. 📜 FDA Updates:  FDA Guidance for Industry - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products - Questions and Answers. FDA Guidance for Industry - Container Closure System and Component Changes: Glass Vials and Stoppers. 🌍 European Medicines Agency Guideline update:  Guideline on the chemistry of active substances. 🔍 ASPHALION experts are on top of these developments, ensuring our clients stay ahead of the curve and in full compliance with regulatory standards.  🔗 Read the full article and changes here: https://bit.ly/3YtFqNA If you need any help, contact us at: [email protected]   #FDA #EMA #Biosimilars #DrugManufacturing #RegulatoryAffairs #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience  

📢 Regulatory Update: Attention to Child Safety 🚸 The Central Drugs Standard Control Organisation (CDSCO) has taken a significant step by prohibiting the use of a common cold fixed drug combination for children under 4. This combination comprises chlorpheniramine maleate and phenylephrine. The decision, rooted in recommendations from the Subject Expert Committee (SEC), highlights the importance of caution for children below the age of four. In response, manufacturers of this fixed drug combination have been mandated to include a warning on both labels and packages, explicitly stating, "FDC should not be used in children below 4 years of age." This regulatory order, issued on December 18 and recently made public, underscores the commitment to child safety in pharmaceutical practices. Stay informed, advocate for safe healthcare practices, and share this crucial update within your professional network. #healthcareregulation #childsafety #pharmaceuticalupdate

In 2023, the FDA approved 51 novel drugs to manage a broad spectrum of medical conditions. In this video we highlight 8 drugs that are set to have a significant impact.  https://lnkd.in/dRQpvN9B #pharmascribe #videoscribe

📌 NEWS \| Publication of two guidelines from the FDA and one from the EMA Two guidelines from the FDA were updated and one from the EMA. 📜 FDA Updates:  FDA Guidance for Industry - Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products - Questions and Answers. FDA Guidance for Industry - Container Closure System and Component Changes: Glass Vials and Stoppers. 🌍 European Medicines Agency Guideline update:  Guideline on the chemistry of active substances. 🔍 ASPHALION experts are on top of these developments, ensuring our clients stay ahead of the curve and in full compliance with regulatory standards.  🔗 Read the full article and changes here: https://bit.ly/3YtFqNA If you need any help, contact us at: info\\@asphalion.com   #FDA #EMA #Biosimilars #DrugManufacturing #RegulatoryAffairs #RA #WeAreAsphalion #WeCare #KnowledgeFromExperience  

🔔 Coming June 26! If you work on prescription drug promotion, don’t miss this webinar! Learn directly from FDA experts about the different categories and types of promotion, as well as the regulatory requirements for each. The discussion will cover the clear, conspicuous, and neutral (CCN) final rule, the five standards associated with the rule, and the rule’s compliance date. Register ➡ https://lnkd.in/eyPqVMF4

So many #PGx labs are popping up weekly. Excessively large panels can provide pages of useless information. It is important to carefully research labs before working with them as the quality and reliability of genetic testing can vary significantly. #pharmacogenomics #precisionmedicine