Biologic Drugs

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

The membrane-based Protein A purification tool was unveiled at the 2017 PepTalk Conference in San Diego, California.

Language surrounding regenerative medicine and the REGROW Act appeared back into the 21st Century Cures Act right before it passed. What will this mean for the controversial testing and marketing of stem-cell therapies?

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.

A pilot project, beginning in 2017, will support the development of biosimilars.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

Reliable, high-quality products require innovative analytics and production.

Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.

The biosimilar pathway permits licensure based on less than full clinical data.

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

Novasep’s BioSC Lab chromatography is a flexible equipment that enables operations from one column up to six columns in batch, parallel batch, or continuous processing with all media and membrane types.

The winning entry was Merck’s Emprove program, which facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing.

A PESU membrane is now available for Sartorius Stedim Biotech Sartocon benchtop and production-scale filtration assemblies.

Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.

Containing costs and improving compliance will be crucial to ensuring the growth of generic pharmaceuticals in the future, says Dilip Shah, CEO of Vision Consulting Group, in CPhI’s 2016 Annual Report, which will be formally issued at CPhI 2016 in Barcelona.

The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.

West will showcase several drug-delivery systems and packaging component technologies such as its NovaPure plungers and SmartDose technology platform.

R-Pharm facility in Yaroslavl, Russia, is designed to produce biological drugs with GE Healthcare's FlexFactory manufacturing platform.

Aptar Stelmi will present PremiumCoat, an alternative coated stopper for sensitive drugs, at CPhI 2016.