Patrick Lavery

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The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug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.

The treatment becomes the only approved twice-yearly option for pre-exposure prophylaxis for HIV prevention in the European Union.

This comprehensive overview of contemporary formulation strategies covers the drug product lifecycle from end to end, illustrating best practices for various formulation types seen through a CRDMO’s lens while also covering problem solving, the role of digital tools, and geopolitical changes.

The recall was in response to particulate matter found in the container.

Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.

The company’s commitment to its North Chicago, Ill. plant is part of a previously announced $10 billion capital investment earmarked for the expansion of US innovation and manufacturing capacity.

The company is not developing an mRNA vaccine, but had been using one as the control in a 10,000-subject Phase IIb trial.

For the first target addressed in the partnership, the two companies reported the successful delivery of AI-designed, functional antibody leads.

Experts from LGM Pharma and Rockwell Automation share their thoughts on what makes tech transfer effective, where processes could be improved, and why certain development and manufacturing decisions are so crucially important.

Orforglipron showed clinically meaningful results at 72 weeks, after three doses, in a pool of more than 3000 adults.

A new nuclear magnetic resonance method reveals real-time, coordinated changes in nanoemulsion drugs, improving noninvasive analysis and regulatory evaluation.

The company’s FDA-approved first generic sertraline capsules secured a 180‑day exclusivity period, highlighting strategic generic development pathways.