Patrick Lavery

Data from four major pivotal trials will be shared, but AstraZeneca medications and pipeline molecules appear in more than 90 abstracts for the upcoming conference in Berlin.

US President Donald Trump made the announcement that AstraZeneca is the second of 17 major pharmaceutical companies, after Pfizer, to agree to most-favored-nation pricing protocols.

Pharma accelerates specialized R&D and clinical pipelines via agentic AI and collaboration, while manufacturing scales through CGT 2.0 flexibility, automation, and digitized supply chain security.

AstraZeneca’s $4.5 billion investment in Virginia expands its US drug manufacturing footprint, creating 3600 jobs and integrating AI for cancer and metabolic therapies.

The new label for prefilled syringes, in conjunction with innovations from SCHOTT Pharma, enables integrated tamper-evidence and digital tracking across the supply chain.

The awarded $1.7 million in funding will support the company’s preclinical and clinical progress on DMX-1001 (noribogaine), designed to reduce relapse and improve brain health in patients with alcohol use disorder.

The licensing of Talicia, an FDA-approved fixed-dose therapy, to key at-risk markets strategically combats an increasingly high antibiotic resistance to the cancer-causing bacteria.

Pharma news on AI's role in drug development, new FDA/EMA guidance, clinical advances, MFN pricing agreements, and ongoing quality control challenges.

The go-ahead for Novartis’ oral treatment marks a new option for patients with spontaneous urticaria who remain symptomatic despite antihistamine therapy.

Sept. 30 marked 61 days since July 31, one day past the timeframe President Donald Trump had set forth for companies to lower prescription drug prices in the United States.

FDA's Center for Biologics Evaluation and Research has released updated draft recommendations for sponsors of cell therapies, gene therapies, and tissue products.

Your weekly news hub for biopharma trends, FDA regulations, M&A deals, supply chain insights, drug development innovations from BIO-Europe, and more.

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.

In this exclusive Drug Digest video, Steve Barr from SK pharmteco and Prasad Raje from LGM Pharma explore how supply chain pressures, sustainability, and AI adoption are reshaping small molecule development and excipient use in pharma.

The company, under parent ICE Pharma, will celebrate its past achievements, present its expertise and plans for the future, and unveil a “100 Years” logo.

The company has expanded its CDMO offerings in recent years, adding to decades of experiences in solutions such as moisture management.

Misleading promotions of GLP-1 and compounded semaglutide products are drawing renewed regulatory scrutiny over risk disclosure and safety messaging.

Corstasis Therapeutics plans to launch the product in the United States in the fourth quarter of 2025.

The 2024 edition of the annual conference, held in Milan, attracted more than 59,000 professionals from across the bio/pharmaceutical landscape.

Merck’s Sanat Chattopadhyay called for stronger leadership, data-driven oversight, and shared accountability to raise pharmaceutical quality standards.

Charles Gibbons of Lachman Consultants and Michael Grischeau of AbbVie stressed AI governance, data integrity, and human oversight as essential to applying digital tools across labs and supply chains.

The performance of ARS Pharmaceuticals’ Neffy marginally outpaced historical reports of epinephrine injection effectiveness.

More than 700 out of 1000 senior executives surveyed believe that next-gen supply chains should be among the top tech priorities for life sciences organizations.

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

The nonprofit is calling upon its community of experts in both artificial intelligence and machine learning to continue building support for responsible adoption of AI in the bio/pharmaceutical industry.

The partnership, which has received £118 million (US$158 million) in research funding, aims to establish a better understanding not only of how the body fights infection, but also how vaccines protect it.

Aficamten is a small-molecule cardiac myosin inhibitor that was compared for the first time in the trial to the standard-of-care beta blocker.

AC-201 is being developed in a novel, oral formulation as a potent inhibitor that binds to the pseudo kinase domain, JH2, of TYK2/JAK1.

Cereno reports that its lead program, CS1, demonstrated encouraging efficacy while meeting its primary endpoint of safety and tolerability in a Phase IIa trial.