News

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

Oncologist Stephen Hahn has been nominated for the top post, following the appointment of Brett Giroir as acting commissioner.

Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.

The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.

The transaction is expected to be finalized in early 2020.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.

The technology is set to heighten the company’s GPEx expression platform through the utilization of a glutamine synthase knock-out Chinese hamster ovary cell line.

The company will invest $24 million into its Inchinnan, Scotland, site to expand global bioproduction capabilities with additional large-volume liquid manufacturing capacity for cell-culture media.

Schott will combine its adaptiQ platform with West’s Ready Pack system.

The winners were announced during day one of CPhI Worldwide.

The partnership will center on the development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase I clinical development, using its proprietary RNAi platform technology.

The report focuses on information from stakeholders, published research, and economic analysis of market conditions from an analysis of drug shortage data and development of recommendations by the inter-agency Drug Shortage Task Force led by FDA.

Published on Oct. 29, 2019, the study focuses on the multidrug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa) and how it can be used to develop new and sustainable antibiotic treatments.

The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.

Showing gains of 54% compared with 2018, results from a 2019 study showed that nearly three-quarters of pharma barcodes meet Drug Supply Chain Security Act requirements.

Arranta Bio has completed an $82-million round of funding and has scored a strategic partnership with Thermo Fisher Scientific.

The companies will develop innovative formulations for drugs to treat rare diseases using Catalent’s oral disintegrating tablet technologies.

Breaking with tradition, a compounding facility won for overall operational excellence, while biopharma facilities took home awards in various categories.

The new facility is 15,000 ft2, which includes 8000 ft2 of lab space and 7000 ft2 of office space.

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

Clear Advantage is a product line of multichannel reagent reservoirs to be used for creating a next-gen sequencing library

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

The successful inspection comes after the facility passed a pre-approval inspection in June 2019 from Japan’s Pharmaceutical and Medical Device Agency for an innovative drug.

The approval marks the first time a new glass composition has been approved by FDA since the approval of borosilicate glass more than 100 years ago.

GE Healthcare Life Sciences’ KUBio box is an integrated, flexible biomanufacturing environment for viral vector-based gene therapies.

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.