Top News

EMA Recommends Approval of First Stem-Cell Therapy

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

Fujifilm Completes Acquisition of Kalon Biotherapeutics

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

FDA Approves 35 New Drugs in 2014

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

Industry News

EMA Proposes Measures to Lower Risks Surrounding Use of Antibiotics in Animals

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

EMA Recommends Seven New Medicines for Marketing Authorization

The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

Merck Acquires Biotechnology Company, OncoEthix

Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.

Supplier News

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Fujifilm Completes Acquisition of Kalon Biotherapeutics

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

Paragon Bioservices to Scale Up Protein Manufacturing

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Bio/Pharma News

Actavis Announces Senior Leadership Team

Actavis announced a senior leadership team comprised of both Actavis and Allergan leaders designed to facilitate dynamic company growth.

Fujifilm Completes Acquisition of Kalon Biotherapeutics

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

Sandoz's Biosimilar Shows Similarity to Amgen's Neupogen

Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.

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.

Considerations in Developing Sublingual Tablets—An Overview

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

Drug Manufacturing

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Stelis Biopharma Builds Facility in Malaysia

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Year in Review: Trends in Biopharma Manufacturing Outsourcing

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Drug Development

EMA Cautions on Experimental Ebola Treatments in Early Stage Development

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

Shifting Gears in Drug Development Outsourcing Responsibilities

For a bio/pharma industry in flux, contract services are playing a greater—and more diverse—role in drug development.

Solid-Dosage Forms Demand Traditional and Emerging Technologies

Contract development and manufacturing organizations identify trends, challenges, and emerging technology and service needs for solid and semi-solid dosage forms.

Current Issue

Drug Scandals Impact Industry in Japan

The spate of drug scandals may alter the relationship between manufacturers and research institutions, and reshape Japan’s clinical research industry.

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.

Industry Q&A with Dr. Thomas Hein

Dr. Thomas Hein, Director Business Development and Regulatory Affairs at Hermes Pharma, discusses the difference between user-friendly dosage forms and conventional tablets and capsules.

PharmTech Talk

Biosimilar Development Moves Forward at FDA

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

Achieving Long-Term Success in Supply-Chain Security

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

Compassionate Use Debate Heats Up

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

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

FDA Realigns Drug Inspection and Manufacturing Oversight

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

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.

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.