Richard Easton, PhD, is Technical Director–Structural Analysis, BioPharmaSpec Ltd,

Christopher Ziegenfuss is Vice President, at BioPharmaSpec, Inc

Articles

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products. 

ICH Q6B for Analytics

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.

Market Demands and Emerging Technologies Shape Outsourcing Models

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Jon Ellis and Simon Vanstone, PhD, go behind the headlines to explore the latest M&A activity and what tariffs and funding changes could mean for mRNA and beyond.

Behind the Headlines, Episode 18: Sanofi, GSK Go Big in M&A, mRNA Momentum Falters, and More

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

USP Opens Advanced Technology Lab in Maryland

Cheryl Barton is director of PharmaVision, 

EMA has published recommendations to address potential radiopharmaceutical shortages.

EMA Is Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals

The grant encompasses $100,000 each from the Life Sciences Entrepreneurship Center and Berkeley SkyDeck, with SkyDeck having the option to invest an additional $100,000.

UC Berkeley Awards $200K Venture Grant to HypO2Regen Therapeutics

As a result of the decision, Shilpa will not be eligible to receive FDA approval for its lenvatinib mesylate generic until February 2036.

Eisai Wins Judgment Against Shilpa Over Sale of Lenvatinib Mesylate Generic

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.

FDA Grants Fast Track Designation to Teva Celiac Disease Candidate

Both companies viewed the early end to the PIVOT-PO trial as a positive development, with GSK saying it would work with US regulatory authorities to move the treatment forward in 2025.

News