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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.

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.

Merck’s decision to establish oncology as a standalone business unit reflects a strategic response to blockbuster concentration risk, lifecycle complexity, and intensifying competitive dynamics, as the company prepares for the anticipated loss of exclusivity of Keytruda and repositions organizational design as a lever for long-term value protection and growth.

The acquisition builds on the companies’ previous collaboration advancing anitocabtagene autoleucel (anito-cel).

The COVID-19 pandemic dramatically accelerated cancer-vaccine science by validating the mRNA technology at global scale.

Jay Bregman, CEO and co-founder of Andel discusses how FDA’s planned action against non-FDA-approved GLP-1 products could reshape competition in obesity and diabetes care.

BioNTech filed a patent infringement lawsuit against Moderna alleging unauthorized use of patented mRNA technology.

The judges ruled against tariffs levied using an emergency law.

FDA approves AstraZeneca’s fixed-duration, all-oral Calquence plus venetoclax regimen for first-line CLL and SLL in adults.

In this video episode, Pratap Khedkar, PhD, CEO of ZS, joins the Pharm Exec Podcast to discuss three distinct industry trends and strategy shifts converging at the moment amid the backdrop of US-driven global policy change.

In today’s Pharmaceutical Executive Daily, the FDA reportedly removes its two-study requirement for new drug approvals, Hims & Hers enters a $1 billion agreement to acquire Eucalyptus, and experts examine how FDA can help ease early-stage clinical trial bottlenecks.

The vaccine advisory committee’s meeting has yet to be rescheduled.

Study results showed that patients saw three years of remission while taking the medication.

Hims & Hers has agreed to acquire Australia-based Eucalyptus for up to $1.15 billion, expanding its international footprint across Australia, Canada, Germany and the U.K.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

In today’s Pharmaceutical Executive Daily, the FDA begins reviewing Moderna’s seasonal flu vaccine under a revised regulatory approach, Eli Lilly signs a $100 million licensing agreement with CSL for an anti- IL-6 monoclonal antibody., and Southern Florida emerges as a growing biotech hub.

Greater Miami is rapidly emerging as an international biotech hot spot—as capital, talent, and infrastructure converge to transform the region from a tourism-driven economy into a globally connected life sciences innovation hub.