BioPharm International Editors

Competence in process safety is important for preventing accidents.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

Project will optimize expansion and harvest of human cells in bioreactors.

New design meets new process requirements.

Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.

Program aims to develop a novel oral treatment.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

Evaluation system for single-use bags and assemblies is now available for onsite testing.

EMA clarifies biosimilars guidelines.

The FDA has accepted for review Merck's Biologics License Application for its investigational ragweed pollen sublingual allergy immunotherapy tablet.

New line in Swiss facility produces ready-to-fill syringes.

New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes.

A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients.

BioPharm International has joined with Dun & Bradstreet Credibility Corp. to launch the Pharmaceutical Technology and BioPharm International Marketplace.

FDA issues draft guidance to minimize medication errors.

Third compounding pharmacy recalls products due to FDA inspection.

Unique technology expands Entegris? fluid-sensing and control offering.

FDA has released Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.

New manufacturing route improves availability of ingredient for malaria treatment.

Big Biotech companies are demonstrating they are better positioned than their pharmaceutical industry counterparts to meet changing demands.

The facility in Hangzhou will package Merck medicines for China and the Asia-Pacific region.

Amgen Inc. has agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act.

$13.6 billion deal strengthens Thermo?s leading role.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

New facility for Bio-Manguinhos will use plant-based protein expression technology.

The process-driven system reduces total cost of ownership.

FDA's FY 2014 budget includes more than $10 million above the 2012 budget for inspections of products and ingredients manufactured in China.

The alliance will develop treatments based on Isis? antisense technology.

FDA inspections of compounding pharmacies result in FDA-483 citations.