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Maher Masoud, CEO of MaxCyte, discusses the need for developers to come together with platforms.

UnitedHealth Group reported stronger-than-expected first-quarter earnings and raised its full-year outlook, signaling improving cost control and early progress in stabilizing performance.

Pfizer’s broad pipeline and recent acquisitions have yet to translate into a coherent market narrative, contributing to investor uncertainty during a critical period of strategic transition.

In today’s Pharmaceutical Executive Daily, Eli Lilly enters a $7 billion agreement to acquire Kelonia Therapeutics, the Trump administration issues an executive order to accelerate FDA reviews of psychedelic therapies, and Lilly’s oral weight loss pill sees strong early prescribing demand.

The Trump administration’s new executive order aims to accelerate FDA review of psychedelic therapies for mental health conditions, highlighting a potential shift in regulatory timelines and expanded access pathways,

Eli Lilly’s acquisition of Kelonia Therapeutics signals a potential shift in the cell therapy landscape, as in vivo approaches aim to overcome the cost, complexity, and access limitations of traditional CAR-T treatments.

Samsung Bioepis’ SVP and head of US commercial discusses the pricing, regulatory, and broader issues impacting the biosimilars market.

Model N’s Michael Grosberg breaks down the accelerated complexity, policy disruption, and data gaps testing manufacturer market access and revenue management strategies.

Market analysts are comparing Foundayo’s sales with other GLP-1 medications, such as the oral version of Wegovy.

Morten Graugaard, CEO, Orbis Medicines, discusses the importance of oral biologics and the industry impacts of FDA's approval of Icotyde.

ARS Pharmaceutical’s CEO discusses how reformulating drugs and updating delivery design can improve the rate of patient adherence to medication.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses how the Tecvayli and Darzalex Faspro combination delivers deep, durable responses, along with its rapid FDA review.

In today's Pharmaceutical Executive Daily, Eli Lilly releases updated safety data for its oral obesity pill Foundayo in response to an FDA post-approval request, ICER and Verdant Research publish a new white paper examining the evolution and future of the FDA's accelerated approval pathway, and a new Pharmaceutical Executive commentary argues FDA's shift toward single-trial approval standards marks the beginning of a genuinely new era in data-driven drug development.

A new ICER white paper calls for reforms to the FDA’s accelerated approval pathway, citing ongoing challenges with regulatory consistency, confirmatory trial delays, and transparency.

Eli Lilly releases new safety data after FDA requested additional data to conduct extensive post-approval safety studies for Foundayo, including long-term monitoring of cardiovascular, liver, and thyroid cancer risks.

Samsung Bioepis’ Thomas Newcomer explains the reasons why biosimilar developers are or are not feeling confident about the consistency of the US market in the coming years.

Imran Khan, Md, PhD, Vice President of U.S. medical affairs for hematology, oncologist, Johnson & Johnson, discusses why J&J was chose for the CNPV program and it's experience during the process.

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.

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.