Pharmaceutical Technology Editors

Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.

Boulting’s inspection software is a paperless, cloud-based system for maintenance of equipment in hazardous areas.

Fette Compacting America has introduced the FEC20 Capsule Filling Machine, capable of producing up to 200,000 capsules per hour, to the North American market.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

Tornado Spectral Systems, winner of the 2018 CPhI Excellence in Pharma Award for Analysis, Testing, and Quality Control, discusses real-time process measurement for biopharmaceutical and small-molecule drug manufacturing.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

The companies entered a license agreement for the Trianni Mouse, a transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies (mAbs), to support MacroGenics’ discovery programs for mAb-based therapeutics.

A new plasma B cell antibody discovery workflow launched by Berkeley Lights enables the shortening of antibody drug discovery from month to a day.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

The Steritest NEO device from MilliporeSigma provides safer pharmaceutical product testing through additional features.

The companies will work together to discover and develop new treatments for neurological conditions such as Alzheimer’s and Parkinson’s disease.

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

Pharmaceutical Technology spoke with Steve Tallant, Systech, about the UniSecure solution, which won the 2018 CPhI Excellence in Pharma Award for supply chain, logistics, and distribution.

The $252-million acquisition is expected to strengthen Cambrex’s position as a small-molecule CDMO across the drug lifecycle.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

Drug pricing and reimbursement concerns will continue to hinder industry growth in 2019, according to data and analytics company GlobalData.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.

Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

The companies will join forces to develop and commercialize an oncology drug to treat hematological cancers.

Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

A report from GlobalData, a data and analytics company, reveals the predicted role of immuno-oncology drug development and personalized medicine in the pharmaceutical industry in 2019.

The $2.1-billion acquisition strengthens Novartis’ position in nuclear medicine and radioligand therapy for treating cancer.

The agency has approved Stemline Therapeutics’ Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm for both adults and pediatric patients.

UK-based biotechnology company, Morphogen-IX, has announced the completion of its Series B financing round