Pharmaceutical Technology Editors

The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.

ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.

PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.

The SCIEX PA 800 Plus Pharmaceutical Analysis system is used to identify and quantify glycans to ensure therapeutic efficacy.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

After a positive Phase II trial, the company said its C. difficile vaccine candidate will advance to Phase III trials during the first half of 2017.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

WuXi AppTech acquired HD Biosciences, a preclinical drug-discovery-focused CRO.

The organization launched its GOBOLDLY campaign to highlight the work of US biopharmaceutical companies.

The company released the Biopharma Compass 2.0 software, which automates workflows for high-resolution mass spectrometry.

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.

Camfil Air Pollution Control has expanded its testing laboratory and added a dust collection test rig for the ANSI dust collection standard.

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.

The presentation details the addition of triethylamine to the guideline on toxic solvents.

EAG Laboratories offers dermal absorption studies using OECD methods.

The agency published an overview of marketing authorizations made in 2016.

Luke Miels will replace Abbas Mussain as president of GSK’s Global Pharmaceutical division later this year.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

With this new line, Bischof + Klein will double its extrusion capacities for its CleanFlex clean room films.

Evotec and MaRS launched Fibrocor Therapeutics, a company dedicated to developing novel therapeutics for fibrosis.

The company opened a facility in Spain dedicated to the production of meglumine.

High Street Capital acquired Avomeen, a full-service chemical testing laboratory, in late December 2016

New website allows access to research quantities of commercial-grade ligands and catalysts.

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

The company announced that it has terminated an agreement made with UMN Pharma for the co-development of influenza vaccine programs in Japan.