BioPharm International Editors

Alkermes plans to advance its investigational new drug-enabling capabilities for lead preclinical assets in the Rodin development candidate portfolio.

The drug will be used to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

If successful, the acquisition will boost Recipharm’s global position in the contract development and manufacturing organization (CDMO) market.

The chapter is open for comment until Nov. 30, 2019.

Through the agreement, Roche will gain full rights to the company’s portfolio of molecules for fibrotic diseases, most notably PRM-151, Promedior’s lead product candidate.

FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

With the gene-editing technology, Evotec will have the ability to accelerate research and enable the testing and development of new drugs.

The new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

The companies will acquire Orflo’s two flagship products, the Moxi Z and the Moxi Go.

The company celebrated 65-years of providing industrial vacuum cleaning systems to the market.

The new company name, Viatris, derives from Latin and represents the company’s main goals.

Norwegian clinical-stage immunoncology company, Lytix Biopharma, has entered into a clinical collaboration with US-based Iovance Biotherapeutics.

A clinical-stage company that was spun out of the VUB university in Belgium, eTheRNA immunotherapies, has revealed it will be participating in an EU research project aimed at developing off-the-shelf mRNA nanomedicines.

A simulation-based drug discovery company, Turbine, has announced the closing of an institutional funding round worth EUR 3 million (US $3.3 million), which will be used to redesign the oncology drug discovery process.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

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.

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

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.