News

The agency has approved Tpoxx (tecovirimat), the first drug with an indication for the treatment of smallpox, to address the impact of a potential outbreak.

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.

FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

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.

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.

Annual awards program recognizes innovation in bio/pharmaceutical drug development and manufacturing.

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

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.

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.

The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

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.