Top News

Novartis to Sell Parts of Sandoz in $1-Billion Deal

Sep 06, 2018

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Emergent to Acquire Opioid-Focused Adapt Pharma in Deal Worth $735 Million

Sep 06, 2018

Emergent BioSolutions is set to acquire Adapt Pharma, a pharmaceutical company focused on addressing the opioid overdose and addiction crisis, in a deal worth up to $735 million.

FDA Expands NDMA Investigation to All ARB Class Drugs

Sep 04, 2018

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

Industry News

Maintaining Cell-Line Integrity is Critical to Product Quality

Sep 25, 2018

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

CPhI Pharma Award 2018 Finalists Revealed

Sep 25, 2018

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.

FDA Awards Five Grants for Advanced Biomanufacturing Research

Sep 24, 2018

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

Supplier News

DSM to Highlight Vitamin and Lipid Portfolio at CPhI Worldwide 2018

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

New Analytical Instrument Could Change Vaccine Development Through Faster Viral Detection

Research by Thermo Fisher Scientific and LumaCyte suggests that LumaCyte's Radiance instrument offers the ability to rapidly analyze viral vaccines to speed development and production and ensure their effectiveness.

BeiGene Selects GE Healthcare’s Biologics Factory to Boost its Manufacturing Capacity

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Bio/Pharma News

EMA’s CHMP Recommends 13 New Medicines for Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

BeiGene Selects GE Healthcare’s Biologics Factory to Boost its Manufacturing Capacity

BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.

Sanofi Refocuses Its Business on Mature and Emerging Markets

The company announced it is creating a new Primary Care global business unit and a China & Emerging Markets unit.

Drug Development

Lonza Expands Product Lifecycle Management Capabilities

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

NIBRT Scientist Leads European Industrial Doctoral Program

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year project for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

Nanoform Invests in Nanoparticle Technology for Drug Development

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Drug Manufacturing

Maintaining Cell-Line Integrity is Critical to Product Quality

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Personalized Pharma Packaging

A keynote session at CPhI will discuss how the trend to personalized medicine affects pharmaceutical packaging.

FDA Awards Five Grants for Advanced Biomanufacturing Research

FDA awarded nearly $3 million in grants for continuous manufacturing and other advanced manufacturing technologies as part of the agency’s efforts to ensure a robust and reliable supply of biological products.

Best Practices

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.

INTERPHEX to Hold Keynote Series on Aseptic, Sterile, and Biologics Drug Manufacturing

Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.

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

FDA Clarifies Worldwide Inspection Policies

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

Biosimilars Battles Heat Up

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Quality Failures at Foreign Manufacturers Prompt Warnings and Recalls

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

PharmTech Europe News

CPhI Pharma Award 2018 Finalists Revealed

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.

DSM to Highlight Vitamin and Lipid Portfolio at CPhI Worldwide 2018

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

EMA’s CHMP Recommends 13 New Medicines for Approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended 13 new medicines for approval, including three orphan drug candidates.

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

Maintaining Cell-Line Integrity is Critical to Product Quality

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

CPhI Pharma Award 2018 Finalists Revealed

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 9, 2018.

DSM to Highlight Vitamin and Lipid Portfolio at CPhI Worldwide 2018

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

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