Top News

First Hospira Biosimilar mAb Approved in West Europe

Feb 17, 2015

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Pfizer to Acquire Hospira for Nearly $17 Billion

Feb 05, 2015

The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provide Pfizer with a whole portfolio of biosimilar products.

Margaret Hamburg Announces She Will Step Down in March 2015

Feb 05, 2015

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

Industry News

PBOA Supports Legislation to Protect FDA User Fees

Mar 03, 2015

The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.

Canon Announces New Biomedical Company

Mar 03, 2015

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

Novel Pharmaceutical Company, Turing, Announces Launch

Feb 25, 2015

Turing Pharmaceuticals announced the launch of its company, the acquisition of three assets from Retrophin, and a new senior management team.

Supplier News

Novasep to Manufacture Celladon's Mydicar API

Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.

SGS Adds Amino Acid Analysis at German Facility

SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.

PBOA Supports Legislation to Protect FDA User Fees

The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.

Bio/Pharma News

Hemispherx Biopharma Incorporates Continuous Manufacturing at its NJ Facility

The upgrades will offer the opportunity for higher product yields and higher purity levels.

Teva Announces Sale of Facility

Teva announced that it would sell its Sellersville, Pennsylvania facility to G&W Laboratories.

J&J Loses First Jury Trial for Risperdal

Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.

Peer-Review Research

Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological Indicators

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Comparing Manufacturing Process Options

A techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.

Drug Manufacturing

Hemispherx Biopharma Incorporates Continuous Manufacturing at its NJ Facility

The upgrades will offer the opportunity for higher product yields and higher purity levels.

Repligen Expands US Manufacturing Facility

A facility expansion adds space for production of Repligen’s tangential flow system.

Teva Announces Sale of Facility

Teva announced that it would sell its Sellersville, Pennsylvania facility to G&W Laboratories.

Drug Development

Superbug Antibiotic Lands FDA Approval

FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.

Novel Pharmaceutical Company, Turing, Announces Launch

Turing Pharmaceuticals announced the launch of its company, the acquisition of three assets from Retrophin, and a new senior management team.

BMS Furthers its Immuno-Oncology Pipeline with Nearly $1.6 Billion in Investments

Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.

Current Issue

Improving Visual Inspection Practices

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.

Special Considerations for Extractables and Leachables Testing in Biological Products

New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.

The New 2014 IPEC Significant Change Guide

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.

PharmTech Talk

Manufacturers Weigh Strategies to Prevent Drug Shortages

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

Is It Time to Ditch QbD for Development by Design? Questions From a QbD Cheerleader

QbD represents a breakthrough in thinking, but does it go far enough to address today's business challenges? NeoStem has expanded it to include business and market issues, in "Development by Design." Could this be (or is it becoming) a new model for pharma?

New Financial Strategies Needed to Support Biomedical Innovation

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

PharmTech Europe

25th Anniversary Issue

Experts review bio/pharma industry growth and future prospects as Pharmaceutical Technology Europe marks its 25th anniversary.

 

 

 

PharmTech Europe Archives

 

Editor's Picks

Novel Technologies Win CPhI Pharma Awards

On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.

FDA Realigns Drug Inspection and Manufacturing Oversight

Operational changes at FDA and CDER aim to improve global market monitoring.

The Bio/Pharma Working Life

Professionals share the ups and downs of working in the bio/pharma industry.

Using Robotics In Pharmaceutical Manufacturing

Robots are proving advantageous in filling, inspection, packaging, laboratories, and the manufacture of personalized medicine.

USP Supply Chain Safety Videos

eBook Series

Analytical and Bioanalytical Testing eBook 2014

The editors of Pharmaceutical Technology review best practices and methods for analytical and bioanalytical testing.

Bioprocessing and Sterile Manufacturing

Review emerging trends in the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and single-use technologies.

Solid Dosage and Excipients

Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.