Pharmaceutical Technology Editors

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

The company plans to purchase and develop an 18-acre site in Des Plaines, Illinois.

The company announced that it will be relaunching its customer collaboration centers.

The company is voluntarily recalling a docusate sodium solution distributed by Rugby Laboratories due to risk of contamination.

The company invested $50 million in an expansion at its Charles City, Iowa facility.

The company invested in the MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Illinois facility.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

On July 19, 2016, Pfizer announced that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). According to the company, WHO prequalification allows for the global use of Prevenar 13 MDV by the United Nations agencies and countries worldwide that require WHO prequalification.The MDV presentation of Prevenar 13 offers benefits to developing countries, including a 75% reduction in:

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

GE further ramps up its cellular and gene therapy offerings with its acquisition of Biosafe, a cell processing solutions company.

MilliporeSigma has entered into an agreement with PCAS to distribute the Expansorb line of biocompatible and biodegradable polymers for sustained-release applications.

EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.

The Sartocon Slice 50 crossflow filter device can be used for membrane screening and small-volume process development.

The FlexAct BT from Sartorius Stedim Biotech is a point-of-use, leak detection system for single-use bags.

The agency reviews hemophilia A, skin, and diabetes treatments, among others.

The agency completes its risk assessment of the blood cancer treatments.

Patheon launches initial public offering to repay outstanding notes and expenses.

The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.

UPS will expand its clinical trial logistics capabilities to include drug and vaccine development.

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

The company will invest €100 million in the expansion of its Athlone facility.

The assay will provide information on biosimilar comparability.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.