Pharmaceutical Technology Editors

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

The Singapore Workforce Development Agency collaborated with governmental groups and industry players to develop a plan to supply biologics-manufacturing workforce demand.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

Atlangram will have access to Carlina’s lipid nanocapsule technology platform Soludots under the terms of the agreement.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic medicines Association (EGA) have announced the reiteration of their joint Europe 2020 Strategy submission ahead of the adoption of the European Commission Work Programme.

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

BioCity has announced a new investment fund, created following a significant contribution by AstraZeneca. The £5 million fund will be managed by BioCity and will make equity investments, typically between £50,000 and £250,000, in life-science companies based at Alderley Park, Cheshire, United Kingdom.

Venair Biotech specializes in single-use products for the biotech and pharmaceutical sectors.

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

Vetter has added a third cleanroom as part of an expansion of its US early-stage development site at the Illinois Science and Technology Park in suburban Chicago.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

The Scottish plant was built by Glaxo in 1980 and will be refurbished in 2015.

Sepha's VisionScan is the first tool-less, non-destructive leak detection device for pharmaceutical blister packs, which uses a camera-imaging technology.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

Optel Vision, a Canadian company specializing in track-and-trace and vision inspection solutions for manufacturing industries, announced that its facility in Limerick, Ireland is now opened to serve customers across Europe.

CDMO Vetter announced the addition of a new flexible serialization service, introduced in response to stricter packaging regulations calling for drugs to be serialized as a means to fight counterfeits.

Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.

The US Federal Trade Commission will require Novartis AG to divest its nicotine replacement therapy patch business to continue the joint venture with GlaxoSmithKline.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Japanese drugmaker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.