Quality Systems

Feliza Mirasol is the science editor for 

Articles

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.

FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides

FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.

First Generic of a GLP-1 Injection Gets FDA Nod to Treat Type 2 Diabetes

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

FDA Creates CDER Center for Real-World Evidence Innovation 

Nicholas Saraceno is editor at Pharmaceutical Commerce.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana Plant

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

PTC Therapeutics Gains FDA Approval for AADC Deficiency Gene Therapy

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

CHMP has granted Eisai Europe and Biogen a positive opinion for the use of their monoclonal antibody therapy in treating early Alzheimer’s disease.

EMA’s CHMP Gives Positive Opinion for Use of Lecanemab in Early Alzheimer’s Disease

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

Videos

Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal Trade Commission actions, tax relief, and Health and Human Services (HHS) leadership; as well as advancements in CAR-T.

Behind the Headlines: What the U.S. Election Results Mean for Industry, In Vivo CAR-T Applications, and more 

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months. 

J&J’s Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

FDA Rare Disease Innovation Moves Forward

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.

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