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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.

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.

In the second part of his conversation with Pharmaceutical Executive, Sandy Donaldson discusses how pharma marketing teams decide who to target with advertising campaigns.

Competitive simulation is a powerful exercise for leaders and their teams, enabling them to move from strategy to execution in a safe environment.

In today’s Pharmaceutical Executive Daily, AbbVie invests $380 million to expand API manufacturing capacity while Bora Pharmaceuticals and GSK enter a five-year manufacturing agreement, Novo Nordisk announces significant price reductions for its leading GLP-1 therapies, and Astellas enters a billion-dollar global collaboration with Vir Biotechnology to advance PSMA-targeting cancer treatments.

Astellas Pharma Inc. and Vir Biotechnology form a global collaboration to develop VIR-5500, an investigational PSMA-targeted CD3 T-cell engager for prostate cancer.

Starting next January, the list prices for three of the company’s weight-loss medications will reduce.

AbbVie invests $380 million to build two new API manufacturing facilities in North Chicago while Bora Pharmaceuticals Co., Ltd. and GSK have renewed a five-year global manufacturing partnership.

Jay Bregman, CEO and co-founder of Andel, discusses how pharmaceutical companies and digital health platforms may need to rethink commercialization strategies, shifting away from costly mass-market advertising toward employer-focused distribution models.

Sandy Donaldson discusses how pharma companies are developing precise marketing strategies for the modern world.

Immuto’s CEO discusses the benefits of SPCs for target discovery.