Topic

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

Videos

Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.

Dealing with Challenging APIs

Articles

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

EMA Prepared for Health Technology Assessment Regulation Implementation

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, has announced her retirement from the agency.

Cavazzoni Retires as CDER Director

Feliza Mirasol is the science editor for 

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab

Pharmaceutical Technology chats about continuous processes and regulatory considerations for processing equipment with Christian Dunne from ChargePoint Technology.

Using Continuous Processes and Automation to Remove Contamination Risk

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

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

FDA Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

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

The guidance provides recommendations for those interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program.

FDA Publishes Final Guidance on Advanced Manufacturing Technologies

The company is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules.

Quality Systems