News

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 recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.

Bayer and Dewpoint Therapeutics have announced an option, research, and license agreement aimed at developing novel treatments for cardiovascular and gynecological diseases.

Phillips-Medisize, a Molex company, revealed that it is opening a new Global Innovation and Development (GID) office in Copenhagen, Denmark, to support its plans for growth.

Forming part of its ambition to contribute to the fight against AMR, Recipharm has announced that it is joining the AMR Industry Alliance, which is one of the largest coalitions set up to provide sustainable solutions to the growing problem of AMR.

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.

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

NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.

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.

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.

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

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

In batch production, efficient exception management means reducing the time required to identify, review, and resolve process exceptions. Incorporating review by exception functionality within manufacturing execution system (MES) software can streamline biopharmaceutical product release.

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

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.

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.

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.

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

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.