Pharmaceutical Technology Editors

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

Horizon Discovery Group and C4X Discovery Holdings have entered into an exclusive partnership aimed at validating targets and developing next-generation oncology drugs.

Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP

The proposed $12.7-billion deal includes the spinoff of GSK and Pfizer consumer brands to a new UK-listed company.

The STERIS ProKlenz ONE alkaline cleaner now has a label performance claim for biofilm removal, in addition to the product’s existing label as a disinfectant and virucide.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The use of artificial intelligence creates growth opportunities in novel therapeutics development by leveraging multi-sourced data, according to experts at research and consulting firm Frost & Sullivan.

The company’s biosimiliar to Roche’s Avastin (bevacizumab) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

The companies will develop a digital platform for the development and lifecycle management of antibiotics.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.