Nicholas Jacobus

The Supreme Court ruled unanimously in favor of Hikma Pharmaceuticals, finding its generic Vascepa did not infringe Amarin's patents under the skinny-label pathway, a decision that strengthens legal protections for generic manufacturers.

Chai Discovery has licensed its generative AI drug discovery platform to Pfizer, giving the company early access to its next-generation Chai-3 model and a custom model trained on Pfizer's own data.

In today's Pharmaceutical Executive Daily, Eli Lilly escalates its 340B enforcement standoff by notifying covered entities of a five-business-day window to submit required claims data or lose access to 340B pricing, Alnylam Pharmaceuticals and Inceptive Nucleics announce a three-year strategic AI collaboration worth up to $2 billion, and Anne Marie Robertson of Eversana speaks on the trends shaping the future of oncology commercialization following ASCO 2026.

Alnylam Pharmaceuticals has partnered with Inceptive to apply generative AI to siRNA design, pairing Inceptive's biology-trained models with Alnylam's two decades of proprietary RNAi data to accelerate candidate discovery.

In today's Pharmaceutical Executive Daily, Cam Olig of Prescryptive Health touches on the results of a new market access survey, Eli Lilly and Ascidian Therapeutics announce a global research collaboration worth up to $1.9 billion to develop RNA exon editors for inherited kidney diseases, and the FDA issues new draft guidance to reduce the submission burden for gene therapy developers.

Eli Lilly moves to deny 340B discounts to hospitals refusing to submit claims data under its documentation policy, escalating a months-long standoff with the American Hospital Association and prompting calls for federal intervention.

Ascidian Therapeutics has entered a global research and licensing deal with Eli Lilly to develop RNA exon-editing therapies for monogenic kidney diseases, a class of genetic conditions with an unmet need for treatment.

In today's Pharmaceutical Executive Daily, FDA has accepted a new drug application for giredestrant under priority review, FDA also issues a complete response letter for Cingulate's CTx-1301, and Dan Troy, former FDA Chief Counsel, explains the roadblocks and hurdles facing the FDA's efforts to bring stricter oversight to direct-to-consumer prescription drug advertising.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA has issued a Complete Response Letter to Cingulate’s ADHD candidate CTx-1301 over manufacturing-related deficiencies, delaying approval of the once-daily therapy while leaving its clinical safety and efficacy profile unchallenged.

In today's Pharmaceutical Executive Daily, the FDA approves Shionogi's Xocova, a pharma M&A roundup covers Servier's acquisition of Edgewise Therapeutics' muscular dystrophy, Eli Lilly's licensing of Hanmi's long-acting GLP-2 therapy, and the merger of Rallybio and Avenzo Therapeutics, finally Sean Werner examines why breakthrough cell and gene therapies continue to fail at the regulatory finish line.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

A trio of deals from Eli Lilly, Servier, and Avenzo highlights continued industry investment in rare diseases and oncology, spanning gastrointestinal disorders, muscular dystrophy, and next-generation cancer therapeutics.

In today’s Pharmaceutical Executive Daily, Harpreet Singh discusses the evolving regulatory landscape for biopharma, the World Health Organization identifies three priority treatment candidates for the Bundibugyo strain of Ebola virus disease, and this week’s pharma roundup highlights new findings on Mounjaro and long COVID-related immune system changes.

WHO identifies experimental therapies from Mapp Biopharmaceutical, Regeneron, and Gilead as leading candidates for the Bundibugyo strain of Ebola virus disease, as the agency pushes for urgent clinical trials amid a growing outbreak.

Research published this week highlights tirzepatide outperforming other GLP-1 therapies in early type 2 diabetes treatment while separate studies identified autoantibodies as a likely biological driver behind persistent neurological symptoms in some long Covid patients.

In today’s Pharmaceutical Executive Daily, an FDA advisory committee weighs recommendations for the composition of the 2026–2027 Covid-19 vaccines, CVS Health restores coverage for Eli Lilly’s Zepbound while adding the company’s newly approved obesity pill Foundayo, and experts discuss how treatment expectations are evolving in lupus care.

CVS Health is restoring coverage of Eli Lilly’s Zepbound and adding oral obesity drug Foundayo to its formulary, signaling shifting payer dynamics as lower-cost GLP-1 therapies expand access for patients.

FDA advisors are set to meet this week to determine whether Covid-19 vaccines should be updated to target the emerging XFG variant, a decision that could shape the composition of the 2026–2027 immunization season amid ongoing viral evolution.

Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.

Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.

In today’s Pharmaceutical Executive Daily, Eli Lilly announces three acquisitions totaling roughly $3 billion, the FDA approves Hepcludex as the first treatment for chronic hepatitis delta virus infection in the United States, and biotech finance leaders reflect on the lessons learned from navigating two decades of volatile markets.

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.

Eli Lilly enters three separate acquisitions totaling $3.83 billion in a push into vaccines and infectious diseases, signaling a strategic expansion into prevention-focused medicines.

Harpreet Singh, MD, touches on how the Commissioner’s National Priority Voucher program is accelerating regulatory review timelines without fundamentally changing how pivotal trials are designed.

In today’s Pharmaceutical Executive Daily, the FDA approves Datroway for certain patients with metastatic triple-negative breast cancer, leadership changes continue at the National Institutes of Health with the departure of a top infectious disease institute director, and industry experts discuss how real-time data is reshaping biotech decision-making and development strategy.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety

In today's Pharmaceutical Executive Daily, Reuters reports that lower-priced oral GLP-1 pills from Eli Lilly and Novo Nordisk are drawing patients away from compounded weight loss medications, Gilead Sciences' renews its five-year collaboration with WHO and Johnson and Johnson’s collaboration with the Department of Health Abu Dhabi, finally Partha Anbil argues that truly industrializing machine learning and AI in life sciences requires systems that are scientifically credible, clinically defensible, regulatorily traceable, and operationally sustained.

New partnerships from Gilead Sciences and Johnson & Johnson highlight how healthcare companies are using collaborations to expand global disease initiatives and accelerate development of AI-enabled healthcare infrastructure.