BioPharm International Editors

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

The company’s Quantum peristaltic pump uses a patented single-use cartridge technology and is applicable to downstream bioprocessing.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

The BioContinuum Buffer Delivery Platform offers streamlined buffer management and delivers “contiGuous” bioprocessing.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

ITT Engineered Valves presented its new EnviZion hygienic valve technology at INTERPHEX 2019 in New York City.

The Kimble GLS 80 Media Bottle and Multiport Cap System from DWK Life Sciences, showcased at INTERPHEX 2019 in New York City, is capable of performing a multitude of laboratory applications.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Educational sessions on the INTERPHEX show floor will include a panel discussion on implementing continuous manufacturing.

3D printing offers a new design freedom for bio/pharmaceutical manufacturing: whether for “printing” a solid-dosage drug or for creating a piece of equipment for bio/pharmaceutical laboratories or manufacturing facilities.

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

XenTech and the Gustave Roussy Cancer Center have signed a strategic collaboration agreement aimed at the development of a collection of tumor explant models from patients with acquired resistance to targeted therapies.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

The GE Healthcare and Rockwell Automation collaboration will help meet the needs of the biopharma 4.0 era.

The company has launched a comprehensive portfolio of custom cell biology solutions and a new cell-line engineering technology.

The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.

MilliporeSigma added a new cloud-based, remote lab water service and monitoring capability to its Milli-Q CLX 7000 clinical water purification system.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

Distek, a provider of laboratory testing instruments, added a dual impeller single-use bioreactor (SUB) system to its BIOne portfolio.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

A continuous peptide manufacturing process invented by Swedish Biomimetics 3000 Ltd is a platform technology also applicable to other solid-phase chemical processes, such as chromatography.