Michelle Raley’s Post

Day 2 at #RAPSEuroConvergence is off to a great start! Stop by 𝗕𝟮𝟬 𝗶𝗻 𝘁𝗵𝗲 𝗘𝘅𝗽𝗼 𝗛𝗮𝗹𝗹 for a sweet treat! Cara Vivarelli-O'Neill, MPH is ready to answer any questions—and help you register for a complimentary copy of The #CHMP Meeting Survival Manual. #RegulatoryAffairs #communications #EMA #FDA #pharma #biotech #medicaldevices

In this edition of the New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory

In 2023, savings from generic and biosimilar medicines surpassed $445 billion dollars. Today, on the 40th anniversary of the Drug Price Competition and Patent Restoration Act, commonly known as the “Hatch-Waxman Act,” we stand at a critical crossroads. Policymakers and regulators must work to create long-term sustainability for the generic and biosimilar industries. Swift legislative action is vital! More: https://lnkd.in/eB7-5A8F #generics #biosimilars #hatchwaxman40

📢 We are excited to share that Dr. Darius-Jean Namdjou, our Director, Senior Regulatory Lead at Phortas, recently participated in the European Medicines Agency (EMA) Scientific Symposium on Advanced Therapy Medicinal Products (ATMPs) held at EMA premises, in Amsterdam, Netherlands. You can read more about KEY TAKEAWAYS in our BLOG here: 👉 https://lnkd.in/eMeyDeNd Contact us : 📧 info@phortas.com #ATMP #regulatoryaffairs #blog #phortas #biotech #drugdevelopment

The MHLW Grants Approval to Takeda’s Adzynma (apadamtase alfa/cinaxadamtase alfa) for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP) #takeda #adzynma #congenitalthromboticthrombocytopenicpurpura #regulatory #mhlw #japan #cttp #apadamtasealfa #cinaxadamtasealfa #ultrararebloodclottingdisorder

#Biosimilar medicines are highly similar to reference #medicines without differences in safety, purity or efficacy 💊 #Biosimilars or #biosimilarmedicines are the key to guaranteeing a competitive #pharmacological market, with reasonable prices and capable of rivaling conventional medicines. They can compete with these when they are no longer protected by patent law. 👉 https://lnkd.in/dwqhGZ4r A biosimilar is a #biological #medicine equivalent in molecular structure, pharmacological activity, efficacy and #safety to another biological, authorized in the European Economic Area. Their regulatory consideration is different from that of #genericmedicines, although a high degree of equivalence with the reference medicine in physical-chemical structure and biological-pharmacological activity is required. As a similarity, a biosimilar medicine has the same biological substance as the reference medicine, with a high degree of natural variability throughout the commercial life of the product. Although it will not be more effective than the reference medicine itself, it will contribute to providing a better safety profile. #pharmaceuticalmarket #drugsafety #medicineefficacy #biologicalmedicines #healthregulation #EMAbiosimilars #pharmaceuticalindustry

📌 NEWS \- EMA publishes draft guideline 📢 On July 22nd, the European Medicines Agency \\(EMA\\) published a draft guideline titled "Guideline on the Development and Manufacture of Oligonucleotides" \\(EMA/CHMP/CVMP/QWP/262313/2024-17 July 2024\\). This #guideline addresses specific aspects of the #manufacturingprocess, #characterization, #specifications, and #analyticalcontrol for #syntheticoligonucleotides that are not covered in the existing "Guideline on the Chemistry of Active Substances" \\(EMA/454576/2016\\). ▶ The new guideline aims to facilitate the #marketingauthorization process by providing clear requirements for #clinicaltrial applications. It encompasses considerations related to #conjugation, #activesubstances in solution, #medicinalproduct development, #oligonucleotide #generics development, and #personalizedmedicine approaches. 📅 The public consultation period for this draft guideline begins on July 22, 2024, and ends on January 31, 2025. Stakeholders are encouraged to #review and provide #feedback during this period. ➕ For more details, you can access the guideline here: https://lnkd.in/ekQHMaMC 📧 For further information or requests, contact us

In this edition of the Parexel's New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory

In this edition of the Parexel's New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory

In this edition of the Parexel's New Medicines, Novel Insights newsletter, regulatory experts Cecil Nick and Kurt Brorson, Ph.D., analyze how the FDA’s prior practices shaped this policy change regarding comparative data to support biosimilar switching. Learn about the impact of the new draft guidance for biosimilar developers, with practical applications that have contributed to the evolving regulatory policy on interchangeability. Read the full article below and subscribe to stay updated on the latest #NovelInsights #Biosimilars #FDA #Regulatory