Quality Systems

Feliza Mirasol is the science editor for 

Articles

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia

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

Revised guidelines published by EMA and HMA update the rules on identification of commercially confidential information and personal data used in marketing authorization applications.

Protection of Personal Data in European Medicine Regulation

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

FDA Releases Guidance on Accelerated Approvals

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.

Regulatory Filings and Submissions