2024 remains quiet on the FDA approvals front. Q2 saw a relatively muted 11 novel drug reach that milestone. In his latest article for Nature, Paul Verdin report that while the total number may be low, Evaluate Ltd Pharma forecasts several future blockbusters on the list, including ImmunityBio’s Anktiva. *Subscription may be required. Read now: https://lnkd.in/g6C6vBQS #Pharma #Biopharma #DrugApprovals
Evaluate Ltd’s Post
More Relevant Posts
-
Delving into 2023 drug approvals in our latest special report, we highlight a significant rebound in FDA approvals, particularly for Pfizer, with a noteworthy tally of seven new drugs. Following a subdued 2022 that witnessed only 37 new drug approvals—marking the lowest figure since 2016—the FDA experienced a resurgence, greenlighting an impressive 55 new drugs in 2023. This comprehensive list stands as the second-longest in FDA history, narrowly missing the single-year record of 59 approvals established in 2018. Read the full report! https://loom.ly/yewxcec #FierceBiotech #FiercePharma #FierceHealthcare #Pharma #Biotech #WeAreFierce
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
fiercepharma.com
-
BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #productmarketing #pharmaceutical #healthcare #biotech #pharma
Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA
endpts.com
-
Thoughts on this? >> Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #productmarketing #biotech #pharmaceutical
Avadel's narcolepsy drug Lumryz misses PDUFA date, still under review at FDA
endpts.com
-
Delving into 2023 drug approvals in our latest special report, we highlight a significant rebound in FDA approvals, particularly for Pfizer, with a noteworthy tally of seven new drugs. Following a subdued 2022 that witnessed only 37 new drug approvals—marking the lowest figure since 2016—the FDA experienced a resurgence, greenlighting an impressive 55 new drugs in 2023. This comprehensive list stands as the second-longest in FDA history, narrowly missing the single-year record of 59 approvals established in 2018. Read the full report! https://loom.ly/yewxcec #FierceBiotech #FiercePharma #FierceHealthcare #Pharma #Biotech #WeAreFierce
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
-
ONE System. ONE Outcome. ONE Conference. ALL IN to End Drug Shortages. Register today and unite with pharmaceutical supply chain leaders devoted to forever ending this global crisis at SummitONE 2024. Together, we will create a life-saving supply chain for ALL patients. Register now at https://bit.ly/49riyAt #AllIn2024 #SummitONE #Endingdrugshortagestogether
-
-
Achieving regulatory success for mAb therapies requires a deep understanding of the FDA's unique requirements. Discover how to streamline your regulatory pathway and optimize your mAb program. https://hubs.ly/Q02v_NYn0 #biopharma #pharma #drugdevelopment
Optimizing Your mAb Program: Proven Strategies for Success | Home
-
🆕 Exciting Update for Generic Drug Applicants! Recently, the USFDA released new guidance titled "Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This guidance is designed to support generic drug applicants in understanding the nuances of Product-Specific Guidance (PSG) teleconferences and meetings, a critical part of the GDUFA III framework. This initiative aligns with the FDA's Drug Competition Action Plan, which aims to increase access to safe, high-quality, and effective generic drugs, ensuring patients can access the medicines they need. 🔗 Learn more: https://lnkd.in/g6eyADyh 🔗 More on the Drug Competition Action Plan: https://lnkd.in/dM8f6ydU #Pharma #FDA #DrugRegulation #GenericDrugs #HealthcareInnovation
-
A great interview where our expert on registries Peter M. Wahl, MLA, MS, ScD talks about how this strategic investment can be a robust source for real world evidence (#RWE) able to serve multiple and evolving evidence needs across the drug development cycle. Go take a look and let me know if you would like to discuss with us your specific needs.
With so many options to choose from, Peter M. Wahl, MLA, MS, ScD sits down with Pharmaceutical Executive for a deeper dive into protocol-driven registries, key factors to consider when choosing the registry that best suits your needs, and regulatory requirements. Learn more about the use of registries as sources of regulatory-grade #RWE -->> Click to view the video!
-
The latest FDA guidance for orally inhaled and nasal drug products (OINDPs), released on 15th February 2024, highlights new strategies for demonstrating bioequivalence (BE) that do not require clinical endpoint trials. Clair Brooks, our Applications Specialist, shared her insights with #OINDPnews to discuss these evolving test methods, focusing on realistic aerodynamic particle size distribution (APSD) measurement and the drive for better in vitro-in vivo correlation (IVIVC). Download the full Q&A now ➡️ bit.ly/3zJTzMF #Innovation #Article #Compliance #Pharma #InhalerTesting #DrivingResults #Pharmaceuticals #Formulations
-
-
Thoughts on this? >> FDA gives accelerated approval to PBC drug at the center of Gilead’s $4.3B CymaBay deal >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #healthcare #biotech #productmarketing #pharmaceutical
Gilead wins FDA accelerated approval of seladelpar after acquiring it in $4.3B deal
endpts.com
