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.

Cell Therapy Manufacturing Center to be Built in UK

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Supplier News

Cardinal Health to Build Facility to Manufacture Bayer Radioactive Therapeutic Agent

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

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.

Bio/Pharma News

Merck Acquires Biotechnology Company, OncoEthix

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

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.

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

Cardinal Health to Build Facility to Manufacture Bayer Radioactive Therapeutic Agent

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

Protein Sciences Considers Sourcing Flublok From Japan

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

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

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

Pinpointing the source of Tablet spots and specks

Solving the problem of tablet spots or specks involves prevention and thorough investigation.

Securing the Single-Use Supply Chain

Dual sourcing is one of many possible solutions to securing the supply chain.

Part VII GMPs for Small Molecule Drugs in Early Development Workshop Summary

The authors explore and define common industry approaches and practices when applying GMPs in early development.

PharmTech Talk

More New Drugs and Faster Approvals

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

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.

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.

Eliminating Tablet Spots and Specks

Although the source of spots and specks on tablets is sometimes difficult to identify, following good maintenance and manufacturing practices can help solve or even prevent the problem.

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.