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Pharmaceutical Executive Daily: Eli Lilly Releases Updated Safety Data for Foundayo

ICER and Verdant Research Publish White Paper Examining FDA’s Accelerated Approval Pathway

Eli Lilly Releases Updated Safety Data for Foundayo Following FDA’s Request

What Non-Pricing Factors Are Impacting Biosimilar Decision Making

Johnson & Johnson’s Experience Navigating The Commissioner’s National Priority Voucher Program

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Elevating real-world data (RWD) to the status of regulatory-grade evidence will bring both opportunity and challenges to the industry.

Recent breakthroughs in artificial intelligence allow specialized language models to automatically extract critical information from thousands of complex drug labels in minutes instead of days.

Pharma Finance Roundup: Platform Innovation Drives Biotech Investment Across Oncology and Immunology
Biotech financing activity this week underscores strong investor backing for platform-driven innovation, with capital flowing into ADC development, precision immunology, multi-cancer diagnostics, and non-invasive oncology technologies aimed at addressing persistent gaps in care.

Obsidian Therapeutics and Galera are merging to form a Nasdaq-listed cell therapy company backed by a $350 million private placement, aiming to advance OBX-115, a next-generation TIL therapy.

The IRA and MFN are affecting decisions made all throughout the entire drug development process.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, notes select influences of how the Phase III clinical testing was conducted.

A more dynamic, data-driven approach is redefining what “good” looks like in copay support.

In today's Pharmaceutical Executive Daily, AbbVie licenses a portfolio of pain compounds from China's Haisco Pharmaceutical in a deal worth up to $745 million, the FDA grants full approval to Filspari as the first and only approved treatment for focal segmental glomerulosclerosis, and Pharmaceutical Executive speaks with Deepak Prakash of Identiv on how RFID and real-time tracking are building operational visibility in clinical trials.

AbbVie entered a global licensing deal with Haisco worth up to $715 million to expand its pain pipeline with several assets.

FDA has fully approved Travere’s Filspari for focal segmental glomerulosclerosis, making it the first approved therapy for the rare kidney disease and expanding its role beyond IgA nephropathy.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, touched on Tecvayli plus Darzalex Faspro reducing the risk of disease progression or death by 83%, and what that signals for patients.

Thomas Newcomer of Samsung Bioepis discusses how certain classes of drugs don’t have enough biosimilars in development and the impact that this can have in the coming years.

Identiv’s VP of healthcare discusses the impact of new technology and data collection on trial design.

In today's Pharmaceutical Executive Daily, the FDA issues a second complete response letter for Replimune's RP1 in advanced melanoma, Regeneron and Telix Pharmaceuticals announce a radiopharmaceutical collaboration worth up to $2.1 billion, and Pharmaceutical Executive speaks with Matt Holms of Citeline on improving patient experience and real-world evidence integration in clinical trials.

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program.

























