Operations

AbbVie entered a global licensing deal with Haisco worth up to $715 million to expand its pain pipeline with several assets.

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program.

The U.S. government’s contract with Shionogi highlights renewed public-private investment in antimicrobial resistance and biodefense, aiming to strengthen domestic manufacturing and expand the role of novel antibiotics against high-priority threats.

Dan Bell, chief strategy officer at Marken, discusses how biopharma companies and logistics teams are responding to the dual disruptors to global supply chain operations.

Shah Capital escalates its pressure campaign against Novavax leadership, requesting changes and strategic overhauls amid ongoing performance concerns.

Companion diagnostics are reshaping precision oncology, but clinical adoption continues to lag behind scientific progress due to regulatory, operational and reimbursement barriers.

Disruptions from the U.S.and Iran conflict moves across key transit routes and threatens the flow of active ingredients, price spikes, and heightened risk of drug shortages worldwide.

BioNTech’s decision to close its Singapore manufacturing facility reflects mounting financial pressure, ongoing restructuring efforts, and uncertainty around the pace at which next-generation mRNA therapies will scale.

Neurocrine Biosciences’ planned $2.9 billion acquisition of Soleno Therapeutics includes the addition of Vykat XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome.

Pfizer and BioNTech halted a large U.S. clinical trial targeting healthy adults aged 50 to 64 after enrollment shortfalls made it impossible to generate the post-marketing data the FDA required.

Since the start of President Trump's second term, the FDA, CDC, CDER, and CBER have collectively cycled through more than a dozen leadership changes.

Eli Lilly warns that the UK's current framework is undermining investment and could impact future launches and manufacturing decisions.

The White House postponed naming a permanent CDC director as the Trump administration navigates competing political pressures ahead of midterm elections.

The deal adds OM336, a BCMAxCD3 bispecific T cell engager showing early efficacy in rare antibody-mediated autoimmune diseases, to Gilead's pipeline.

Matthew Turner, President of Patient Affordability, Paysign, touches on how evolving payer tactics appear to be pushing manufacturers toward more sophisticated, partnership-driven program designs.

Inside Consano Bio’s bet on first-in-class nerve repair—and what it takes to lead an early-stage biotech through uncertainty.

FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, pricing uncertainty and safeguards.

The business and market models drugmakers must continually adapt to stay competitive as 2026 progresses.

In this Pharmaceutical Executive Academy discussion, Najat Khan, PhD, CEO of Recursion Pharmaceuticals and former chief data science officer at J&J, explores the intersection of AI, pharma, and patient care — and the strategic pivots necessary to drive measurable and lasting gains across the value chain.

Novo Nordisk is investing to expand its Athlone, Ireland facility, aiming to boost global manufacturing capacity for oral GLP-1 treatments.

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.

Britain’s MHRA intensifies enforcement against illegal weight-loss drugs, seizing nearly 2,000 doses and equipment amid rising global demand for obesity treatments.

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.