Pharmaceutical Technology Editors

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

A Memorandum of Understanding (MoU) has been signed by the UK’s MHRA and the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

TrakCel and WindMIL Therapeutics have formed a partnership to build a custom-configured cellular supply chain tracking and orchestration platform.

Sphere Fluidics has closed its latest investment round in which it raised US$2 million (approximately £1.5 million).

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Formulatrix’s FLO i8 and Flow Axial Seal Tip liquid handlers offer automated transferring.

The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs.

Danapak Flexibles, a subsidiary of the Schur Flexibles Group, will be showcasing its flexible packaging solutions during Pharmapack Europe in Paris, 6–7 February 2019.

Visitors to Schubert-Pharma’s stand at Pharmapack Europe will learn about the company’s range of packaging solutions and engineering services for the pharma and healthcare industries.

SGS announces expansion of cell bank and bulk harvest testing services.

CDMO leader Marc Funk will succeed Ridinger as CEO of Lonza.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

Merck & Co.’s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.

This injection formulation of USP-grade leucovorin calcium is now available in the United States.

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

Horizon and Rutgers University will partner to develop and commercialize new gene editing technology for therapeutic and research applications.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA.

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.

CPhI Worldwide organizers have revealed that the 2020 edition of the pharma event will return to the Fiera Milano venue in Milan, Italy.

The European Medicines Agency has recommended that no new patients should start treatment with Lartruvo (olaratumab).

TC BioPharm (TCB), developer of CAR-T immuno-oncology products, has completed its first allogenic Gamma Delta T (GDT) cell banks.

The Wasdell Group has been granted a Health Products Regulatory Authority (HPRA) license for its new European headquarters, based in Dundalk, Ireland.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

G-CON will provide a complete cleanroom infrastructure for GE Healthcare’s cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.

Lonza’s PyroTec PRO system combines robotic liquid-handling technology with an automation software module.

Company to focus on innovation, growth, and productivity with creation of new units.