Nicholas Jacobus

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.

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 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.

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

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.

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

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.

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.

CSL Limited has licensed global development and commercialization rights for clazakizumab to Eli Lilly and Company outside of ESKD-related cardiovascular risk.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary Robert F. Kennedy Jr. revises the agency’s leadership team, and industry expert Sandy Tammisetty discusses what it takes to deliver actual value in today’s pharmaceutical landscape.

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, Edwards Lifesciences lifts its anti-copycat policy, and industry leaders examine how to scale global medical digital transformation while ensuring local fit.

Following the decisions=, the European Commission decided to close a long-running antitrust investigation

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

In today’s Pharmaceutical Executive Daily, Eli Lilly builds a $1.5 billion stockpile of Orforglipron ahead of an FDA decision, PTC Therapeutics withdraws and plans to resubmit its Translarna NDA, and a former AstraZeneca executive is charged with multiple offenses in China.

Eli Lilly's $1.5 billion pre-launch inventory of orforglipron signals an aggressive manufacturing strategy aimed at avoiding supply shortages and capturing early share in the competitive obesity market.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.

Kim Boericke, CEO, Veristat, discusses how Veristat is adapting clinical trials by using data, AI, and operational planning to optimize site selection, manage complex cell and gene therapy logistics, and streamline analytics.

The indictment of AstraZeneca’s former China chief Leon Wang marks a significant development in Beijing’s probe into drug importation and insurance practices, adding legal pressure even as the company works to stabilize its business in the region.

Sanofi named Belén Garijo as its next CEO, signaling a leadership shift aimed at sharpening execution and R&D productivity as the company moves beyond the strategic overhaul of the past six years.

Kim Boericke, CEO, Veristat, touches on how early strategic consulting, data analytics, and automation help optimize trial design, define realistic patient populations, and generate faster insights.