News

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.

Otsuka Pharmaceutical will acquire Visterra, a clinical-stage biotechnology company focused on developing antibody-based therapies, for approximately $430 million.

CPhI Korea to feature zone for finished dosage formulation drug products.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

Teva Pharmaceuticals USA will move its US headquarters to Parsippany-Troy Hills, NJ.

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Progressive Care’s DischargeRX program works with hospitals and patients to help improve patient medication adherence and minimize medication-related hospital readmissions.

The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

The company opened its new global headquarters in Japan.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.

The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Legislators look to widen access to medications for addiction treatment and overdose emergencies.

The company expanded its extended workbench laboratory services program to support the ongoing manufacturing and development of Flexion Therapeutics’s Zilretta (triamcinolone acetonide extended-release injectable suspension).

Hamilton Robotics and Waters Corporation have partnered to develop StarWorks, automated, end-to-end workstations for biopharmaceutical sample preparation.

Sciex’s latest additions to its biopharma portfolio helps to optimize workflow for better analytics in the lab.

The company unveiled its latest innovations to its mass spectrometry portfolio at ASMS in San Diego.

Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.

The European Directorate for the Quality of Medicines & Healthcare highlighted the organization’s achievements in 2017, including the first mAb monograph.

Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.