As AI rapidly reshapes drug development and clinical operations, industry leaders say transparency, governance, and strong data foundations will determine whether the technology accelerates innovation or stalls under regulatory and operational pressure.
The gap between AI’s abilities and how people use could be about capability, but it’s also about confidence, belief and mindset.
In today’s Pharmaceutical Executive Daily, industry leaders examine how to measure AI’s return on investment across the life sciences value chain, Novo Nordisk commits $506 million to expand its Ireland manufacturing facility, and Bavarian Nordic CEO Paul Chaplin announces plans to step down.
As the AI-first era matures, life sciences leaders must pivot from narrow, task-specific models toward integrated, interpretable frameworks that transform biological complexity into a sustainable competitive advantage.
Bavarian Nordic CEO Paul Chaplin will step down by the end of 2026 after overseeing the company’s transformation into a profitable global vaccine player,
Novo Nordisk is investing to expand its Athlone, Ireland facility, aiming to boost global manufacturing capacity for oral GLP-1 treatments.
Defining the “active ingredient” is the central challenge of biologic PTE, because biologics are large, complex molecules that do not fit neatly into a statutory framework built for small molecule drugs.
In today’s Pharmaceutical Executive Daily, the FDA approves an expanded indication for Palynziq in patients aged 12 and older, Sogroya becomes the first and only weekly long-acting growth hormone approved for pediatric use, and experts examine how real-world data strengthens natural history disease research.
FDA approves a supplemental BLA for BioMarin Pharmaceutical Inc.’s Palynziq, expanding its use to adolescents 12 and older with PKU.
FDA expands approval of Novo Nordisk’s once-weekly Sogroya to include three new pediatric growth disorder indications, offering children as young as 2.5 an alternative to daily growth hormone injections backed by Phase III non-inferiority data.
RWD can bolster natural history studies with insight to longitudinal, real-time disease progression.
In today’s Pharmaceutical Executive Daily, the FDA approves Hernexeos under a national priority voucher program, industry leaders explore the expansion of direct-to-consumer HIV prevention strategies, and Dupixent gains FDA approval for allergic fungal rhinosinusitis.
FDA grants accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib) for treatment-naïve HER2-mutant advanced NSCLC.
Joseph Kleiman examines how Trump Rx could pressure pharmacy benefit managers and retailers to increase transparency and affordability, while cautioning that its long-term impact will depend on price consistency.
Gilead’s VP of marketing and US HIV prevention discusses the new advertising campaign for Yeztugo.
The episode will explore structural implications for supply chains, distribution models, and international strategy—not a political discussion, but a forward-looking planning lens.
In today’s Pharmaceutical Executive Daily, Alkermes outlines its CEO succession plan following Richard Pops’ retirement announcement, leadership changes continue at Sarepta Therapeutics and Rivus Pharmaceuticals, and Boehringer Ingelheim secures an exclusive license for a preclinical small-molecule program.
Boehringer Ingelheim acquires an exclusive license for a preclinical oral immunology program from Sitryx in a deal worth over $500 million in milestones.
Sarepta Therapeutics begins a CEO succession process, while Rivus Pharmaceuticals appoints a new chief executive to advance its late-stage pipeline in MASH, obesity, and cardiometabolic disease.
Alkermes announces that longtime CEO Richard Pops plans to step down on July 31, 2026, with his successor already set to step into the role on August 1.
Otsuka America’s president and CEO discusses being the first major pharma company to invest in psychedelics.
In the final part of his conversation with Pharmaceutical Executive, Sandy Donaldson discusses the challenges that pharma faces when marketing direct-to-consumers.
Buzz Health President Joseph Kleiman discusses how TrumpRx is reshaping drug price transparency, highlighting the benefits of early price visibility for consumers alongside the operational challenges of fluctuating costs, consistency and potential.
In today’s Pharmaceutical Executive Daily, the FDA approves Braftovi for mutant metastatic colorectal cancer, Novo Nordisk and GSK announce major deal activity in a mergers and acquisitions roundup, and UK regulators confiscate thousands of doses of illegal weight-loss medicines.
Britain’s MHRA intensifies enforcement against illegal weight-loss drugs, seizing nearly 2,000 doses and equipment amid rising global demand for obesity treatments.
Novo Nordisk partners with Vivtex Corporation to develop next-generation oral biologics for obesity and diabetes, while GSK agrees to acquire 35Pharma Inc. to expand its pulmonary hypertension pipeline.
The approval makes Dupixent the first FDA-approved therapy for allergic fungal rhinosinusitis, supported by Phase III data showing significant improvements in sinus opacification, nasal symptoms, and reductions in surgery and systemic corticosteroid use.
The agency converted Braftovi’s accelerated approval to full approval after Phase III BREAKWATER data demonstrated significant improvements in progression-free and overall survival in patients with previously untreated BRAF V600E–mutant metastatic colorectal cancer.
Jay Bregman, CEO and co-founder of Andel, discusses how FDA’s action signals a broader regulatory recalibration aimed at protecting intellectual property and explores the second-order effects.
David Graziano, head of retail network at GoodRx, says the FDA’s crackdown on non-approved or “copycat” GLP-1 drugs could shift demand toward FDA-approved therapies while increasing the importance of affordable access through retail pharmacies.
