Nicholas Jacobus

FDA has approved Merck’s Idvynso, introducing a differentiated, two-drug, non-INSTI, tenofovir-free HIV regimen that maintains viral suppression while offering a potentially more tolerable, simplified option for long-term patient management.

Amazon has launched a new GLP-1 weight management program through its One Medical network, integrating obesity treatment into primary care while expanding access to both telehealth services and a range of branded medications.

Supply chain chokepoints are converging to expose deep structural vulnerabilities in the U.S. drug supply, with new data showing that even medicines not currently in shortage may be one disruption away from crisis.

In today’s Pharmaceutical Executive Daily, UnitedHealth raises its full-year profit forecast following stronger-than-expected first-quarter results, Pfizer works to reshape its leadership narrative as it approaches a major patent cliff, and a new industry perspective highlights why scaling artificial intelligence in pharma requires more than just advanced algorithms.

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.

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.

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.