Top News

WHO Pushes for Prompt Reporting and Public Disclosure of Clinical Trial Data

Apr 17, 2015

WHO says that results from clinical trials should be reported within 12 months of completion of the study

EMA and HMA Reveal Network Strategy for Next Five Years

Apr 15, 2015

This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.

Positive Phase III Results Ends Pfizer’s Ibrance Trial Early

Apr 15, 2015

Pfizer announces that its Phase III trial for Ibrance met its primary endpoint and was ended early due to efficacy based on an assessment by an independent Data Monitoring Committee.

Industry News

EMA Finds Scientific Advice Leads to Stronger Trial Design

Apr 20, 2015

The European Medicines Agency releases findings from marketing authorization application analysis.

India May Take WTO Action after EMA Drug Suspension

Apr 16, 2015

India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.

WHO Pushes for Prompt Reporting and Public Disclosure of Clinical Trial Data

Apr 17, 2015

WHO says that results from clinical trials should be reported within 12 months of completion of the study

Supplier News

Sartorius Stedim Biotech Acquires BioOutsource

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

CPhI Japan Set for April 22-24 in Tokyo

Japanese pharma market evolves towards generics and innovative products, reports CPhI, as CPhI Japan 2015 commences.

Udit Batra to Head Combined Merck and Sigma-Aldrich Business

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

Bio/Pharma News

GSK Recalls Flu Vaccine

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Combination of Yervoy and Opdivo Shrinks Melanoma Tumors Drastically in NEJM Case Report

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

Hydra Biosciences Enters into Collaboration Agreement with Boehringer Ingelheim

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

Peer-Review Research

The Human Microbiome Project and Pharmaceutical Quality Control Microbiology

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

Monitoring Fluid-Bed Granulation and Milling Processes In-Line with Real-Time Imaging

The pharmaceutical manufacturing platforms of fluid-bed granulation and milling are widely used to modify particle size. However, the adoption of process analytical technology to monitor and control these processes is difficult because of their dynamic nature. This study examines the efficacy of a particle characterizing technology to capture particle images under dynamic conditions and to calculate particle size distribution data both in-line and at-line during fluid-bed granulation and milling.

Drug Manufacturing

India May Take WTO Action after EMA Drug Suspension

India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.

Core Coating Module Expands Capability of Tablet Press

A core coating module allows Roeltgen's FlexiTab development and small-batch tablet press to manufacture multi-layer and externally lubricated tablets.

Using Polymers for More Efficient Hot-Melt Extrusion and Spray Drying

New cellulosic polymers have been shown to improve solubility in these key amorphous solid dispersion processes.

Drug Development

Antibiotic Drug Development Makes a Turning Point

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

Predicting Meaningful Process Performance

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

The Role of Regulatory Advice in Drug Development

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?

Current Issue

More Evidence that Size Matters

Big service providers get bigger faster thanks to Big Pharma.

Drug Discovery and Development in India

Hope abounds for local drug discovery companies despite challenges at home.

Modern Manufacturing Systems Key to FDA Quality Initiative

More reliable operations would accelerate product development and prevent drug shortages.

PharmTech Talk

Antibiotic Drug Development Makes a Turning Point

The growing threat and spread of antimicrobial resistance continue to ring alarm bells worldwide.

Indonesian Pharma Market Poised for Strong Growth

CPhI report notes that the Indonesian pharma market is on the brink of a regional manufacturing boom, with market capitalizations and company values rising.

Welcome to the Biosimilar Era

FDA approves a biosimilar and loses a commissioner in March.

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

Considering GMPs In Room Design

Cleanability is crucial when choosing components for GMP manufacturing areas.

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Lyophilization Cycle Optimization of Cell-Derived Products

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Improving Visual Inspection Practices

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

USP Supply Chain Safety Videos

eBook Series

Solid Dosage and Excipients 2015 eBook

Pharmaceutical Technology's 2015 Solid Dosage and Excipients eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices for solid- and semi-solid dosage forms.

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.