Top News

Sandoz Humira Biosimilar Patent Dispute Resolved

Oct 12, 2018

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B

Oct 10, 2018

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

Companies Stepping Up Efforts to Ensure Medicine Supply Post-Brexit

Sep 27, 2018

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

Industry News

Scientists Develop New Vaccine for Lassa Fever and Rabies

Oct 12, 2018

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

Congressional Action Alters FDA Policies, Pharma Practices

Oct 10, 2018

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

After a Record Year for Counterfeiting, Efforts Intensify to Secure the Supply Chain

Oct 10, 2018

Cost and IT practices may be holding back progress.

Supplier News

Almac Invests in Next-Generation Sequencing Capabilities

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

AGC Biologics Adds Mammalian Production Capacity in Japan

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

PCI Bolsters Global Drug Development and Commercialization Capabilities with Three Acquisitions

The company’s three acquisitions over the last 12 months have increased its global presence, expanding its European footprint and bringing new localized services in Asia-Pacific and the west coast of the United States.

Bio/Pharma News

Sandoz Humira Biosimilar Patent Dispute Resolved

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Roche Acquires Tusk Therapeutics

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

GSK, Hitachi Chemical in T-Cell Manufacturing Pact

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

Drug Development

Scientists Develop New Vaccine for Lassa Fever and Rabies

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

Biologic Drugs Challenge the Biopharma Industry

Advances in biologic drug development require increased methodological and technological innovation from the biopharma industry. Learn more at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Efficiency Demands Drive Advances in API Labs

Integration of new modeling and analytical tools with flow chemistry are notable trends.

Drug Manufacturing

Advanced Paddle Blender for Labs

Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.

AGC Biologics Adds Mammalian Production Capacity in Japan

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

GSK, Hitachi Chemical in T-Cell Manufacturing Pact

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.

Best Practices

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

The Power of In Vitro Assays in Immuno-Oncology

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

Standards/Regulations

Disputes Over SPC Waivers

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

Pharmaceuticals in the Environment

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

Sponsored Videos

PharmTech Talk

Congressional Action Alters FDA Policies, Pharma Practices

Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.

Manufacturers Face Challenges in Developing New Antimicrobials

FDA is joining with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to support innovation in antimicrobials.

Overhaul of New Drug Approval Process Moves Forward

CDER director plans to start implementation of new review practices by the end of 2018.

PharmTech Europe News

Sandoz Humira Biosimilar Patent Dispute Resolved

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

Roche Acquires Tusk Therapeutics

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

Protecting Antibody IP: Consider Regional Differences

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

PharmTech eBook Series

 

Biologics and Sterile Drug Manufacturing 2018 eBook

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.  

View E-Book

 

Peer-Review Research

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Oral Delivery of Macromolecular Drugs

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

More eBooks

 

CPhI Update

Protecting Antibody IP: Consider Regional Differences

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

PCI Bolsters Global Drug Development and Commercialization Capabilities with Three Acquisitions

The company’s three acquisitions over the last 12 months have increased its global presence, expanding its European footprint and bringing new localized services in Asia-Pacific and the west coast of the United States.

Pylote and Amcor Introduce Package for Liquid Pharmaceuticals Without Preservatives

A stick-pack laminate packaging film from Amcor uses Pylote’s antimicrobial packaging technology to eliminate the need for preservatives in the liquid pharmaceutical contents.

lorem ipsum