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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

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SRP-001: redefining pain treatment with a safer, non-opioid analgesic

Drug Target Review

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures.

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Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

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Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

This assessment is due to be published for public comment by June 30, 2025 , will a public meeting to be held by September 30, 2025 “to discuss the report, its findings, and the Agency’s specific plans to address the report recommendations.” Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ].

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Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What about combination products?

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Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. ?.

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.