Top News

Takeda Faces Cancer Lawsuits with $2.4 Billion in Settlements

Apr 30, 2015

Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.

The Acquisition Battle Continues with Another Perrigo Rejection

Apr 30, 2015

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Mylan Ups Offer to Perrigo to More than $32 Billion

Apr 29, 2015

After rejecting Teva’s unsolicited $40 billion purchase offer, Mylan has increased its own offer to purchase Perrigo from $29 billion to over $32 billion in cash in stocks.

Industry News

Sonneborn Announces New CFO

Apr 24, 2015

Sonneborn announces that it named Gregg Kam as its new chief financial officer.

L. B. Bohle’s Technology Center Merges All Steps of Continuous Production

Apr 22, 2015

With the inauguration of the Technology Center, the engineers, scientists, pharmacists, and IT developers for the first time closed the loop control circuit of a modular system along the entire process including production, sensor technology and controlling.

Endolysin Technology Presents an Antibiotic Alternative with Broad Applicability

Apr 21, 2015

Endolysin technology targets unwanted bacteria, including resistant strains.

Supplier News

Chinese API Manufacturer Warned for Data Integrity Issues

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

IDT Biologika Vaccine Facility Recognized

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

Rentschler Biotechnologie Expands Single-Use Capabilities

Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.

Bio/Pharma News

Novo Nordisk Invests DKK1.5 Billion in New Manufacturing Facility

Novo Nordisk announces that it will invest DKK1.5 billion (US$224 million) in a haemophilia treatment manufacturing facility in Denmark.

Bayer Buys Rights to Isis Pharma’s Blood Thinner for Up to $155 Million

Bayer announces that it will pay up to $155 million, plus royalties, for the rights to Isis Pharma’s anti-clotting drug, ISIS-FXI.

Takeda Faces Cancer Lawsuits with $2.4 Billion in Settlements

Takeda Pharmaceutical agrees to pay $2.4 billion to settle lawsuits from patients and family members who said the diabetes drug Actos caused bladder cancer.

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

IDT Biologika Vaccine Facility Recognized

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

Capsugel Produces DPI Phase 2 Trial Supplies

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

Novo Nordisk Invests DKK1.5 Billion in New Manufacturing Facility

Novo Nordisk announces that it will invest DKK1.5 billion (US$224 million) in a haemophilia treatment manufacturing facility in Denmark.

Drug Development

Bayer Buys Rights to Isis Pharma’s Blood Thinner for Up to $155 Million

Bayer announces that it will pay up to $155 million, plus royalties, for the rights to Isis Pharma’s anti-clotting drug, ISIS-FXI.

Innate Pharma Announces $1.3 Billion Collaboration with AstraZeneca

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

Dicerna Receives Orphan Drug Designation for PH1 Treatment

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

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

Capsugel Produces DPI Phase 2 Trial Supplies

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

Congress Encourages Modern Drug Manufacturing

The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.

Breaking Down Pharma Borders

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

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.