Daniele Coretti’s Post

Take a look at the remarkable achievements of the Office of New Drugs (OND) for 2023! This annual report from the OND details groundbreaking drug approvals for rare diseases to diverse efforts in managing chronic disorders and combating infectious diseases! See the full report below. #OfficeOfNewDrugs | #PublicHealth |#HealthcareInnovation |#RegulatoryScience | #DrugDevelopment | #PatientCare | #FDAApprovals

NDC: (National Drug Code) is a unique numeric identifier assigned to medications, enabling accurate and standardized identification of drugs for billing, reporting, and regulatory purposes.

We just released our July Pipeline Report! 🚀✨ This comprehensive report offers insights into recent drug approvals, products on our radar, and more! 📊🔍Get your hands on the full report: https://bit.ly/3A2wTXA #pipelinereport #newmedications #fdaapproved #specialtypharmacy

Expedited Withdrawal of Drugs Approved via the Accelerated Approval Pathway FDA’s Accelerated Approval (AA) pathway has often been a subject of public criticism due to the apparent approval of inefficient drugs based on preliminary and/or partial efficacy data. However, the AA is a conditional approval that can be withdrawn if the conditions are not met. This week, the FDA released a new guidance document whose primary purpose seems to be to show the expedited withdrawal process for AA drugs. Read More: https://lnkd.in/g6gasTPP Author: Dr. Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #drugs #drugsapproved #fdaregulations #fdacompliance

We just released our July Pipeline Report! 🚀✨ This comprehensive report offers insights into recent drug approvals, products on our radar, and more! 📊🔍Get your hands on the full report: https://bit.ly/4frsUEg #pipelinereport #newmedications #fdaapproved #specialtypharmacy

Licensing deal volume was down, yet value was up in H1 2024. Discover how this trend is reshaping the competitive landscape in drug development. Download the #PharmaDeals H1 Review of 2024 to find out more https://bit.ly/4gNZQrl #PharmaLicensing #PharmaceuticalStrategy

The IQVIA Pharma Deals Half Year Review of 2024 reveals important trends in the pharmaceutical sector's mergers, acquisitions (M&A), and licensing activities. Although the number of M&A deals dropped by 20% compared to the first half of 2023, the total value of these deals increased significantly. This shows that big pharmaceutical companies, like Johnson & Johnson, Merck & Co., and Gilead Sciences, are focusing on larger, more strategic acquisitions, especially in the areas of oncology and immunology. Licensing deals also saw a change. While the number of deals fell by 24%, the overall value went up by 22%. This suggests that companies are more interested in securing high-value, later-stage products rather than a large number of early-stage assets. Oncology remained the top focus for deals, driven by advances in immuno-oncology and new treatments like radiopharmaceuticals. Looking ahead, the report predicts that deal-making will continue, particularly as many major drug patents are set to expire. This will push companies to look for new, innovative therapies through acquisitions and partnerships. Although regulatory issues may limit some large deals, targeted acquisitions and licensing agreements will likely remain a key strategy for future growth. For more detailed insights, IQVIA provides a comprehensive analysis on this topic. #pharma #pharmadevelopment #pharmadeals #strategy #pharmastrategy #pharmalicensing #pharmaceuticalstrategy

Find out more about this and the key trends and standout deals shaping the pharmaceutical industry.

The experts at ProEd Regulatory will be attending this important meeting! Glad to see FDA hosting forums that invite the latest thinking in research and development, particularly for diseases that have been underserved. #Schizophrenia and other disorders are particularly challenging to study, and to design trials that demonstrate a clinically meaningful benefit. It will be interesting to hear thoughts on assessments/scales, and cutting edge clinical trial outcome measures. #regulatory #drugdevelopment #clinicaltrialdesign

Many companies want to optimize their drug substance production, but they worry about contamination and product loss. When you’re looking for a CMDO, here are four strategies to maximize drug substance utilization: https://bit.ly/3Xu5nvN #pharmamfg #contractmfg