Nicholas Jacobus

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.

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

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.

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.

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.

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.

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.

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.

Regeneron and Telix have entered a radiopharmaceutical collaboration worth up to $2.1 billion in milestones, combining antibody-based targeting with isotope delivery to develop next-generation precision oncology therapies.

In today's Pharmaceutical Executive Daily, China approves Amgen's tarlatamab for previously treated extensive-stage small cell lung cancer, a large study identifies genetic predictors of GLP-1 weight loss efficacy and side effects, and Pharmaceutical Executive speaks with Phenomix CEO Mark Bagnall on the complex realities of GLP-1 usage that many patients don't anticipate.

New studies from 23andMe suggest genetic variation may modestly influence GLP-1 weight-loss response and side effects.

China approved Amgen’s tarlatamab for previously treated small cell lung cancer, expanding access to the bispecific immunotherapy.

In today's Pharmaceutical Executive Daily, Shionogi receives a contract worth up to $482 million to bolster U.S. preparedness against drug-resistant bacterial threats, Roche and C4 Therapeutics expand their long-standing partnership into a new collaboration to develop degrader-antibody conjugates for oncology, and Pharmaceutical Executive profiles AstraZeneca CFO Aradhana Sarin on how she approaches the role as a strategic catalyst for growth.

C4 Therapeutics and Roche expanded their partnership to develop next-generation degrader-antibody conjugates, a novel oncology approach designed to improve the precision and therapeutic index of traditional antibody-drug conjugates.

The U.S. government’s contract with Shionogi highlights renewed public-private investment in antimicrobial resistance and biodefense, aiming to strengthen domestic manufacturing and expand the role of novel antibiotics against high-priority threats.

In today's Pharmaceutical Executive Daily, activist investor Shah Capital escalates its campaign against Novavax's board ahead of the company's annual meeting, a Louisiana federal judge declines to block mail-order access to mifepristone while leaving open the possibility of a future ruling against it, and a Q&A examines how the pharmaceutical industry is navigating the compounding pressures of the Iran war and tariff uncertainty on global supply chains.

A federal court’s decision to temporarily allow continued mail distribution of mifepristone underscores the ongoing legal and regulatory uncertainty surrounding abortion access.

Shah Capital escalates its pressure campaign against Novavax leadership, requesting changes and strategic overhauls amid ongoing performance concerns.

Disruptions from the U.S.and Iran conflict moves across key transit routes and threatens the flow of active ingredients, price spikes, and heightened risk of drug shortages worldwide.

In today's Pharmaceutical Executive Daily, Novo Nordisk launches Wegovy HD nationwide across the U.S., Gilead Sciences agrees to acquire German antibody-drug conjugate biotech Tubulis for up to $5 billion, and Pharmaceutical Executive marks World Health Day 2026 with a collection of voices from industry leaders on what it means to stand with science.

Novo Nordisk’s U.S. launch of a higher-dose Wegovy formulation highlights Novo's effort to extend efficacy, capture broader patient demand, and reinforce its dominance in the rapidly expanding obesity market.

Gilead Sciences’ acquisition of Tubulis underscores the intensifying industry focus on antibody-drug conjugates as a key frontier in oncology treatment.