Pharmaceutical Technology Editors

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The agency has recommended granting marketing authorization in the EU for Truvada.

The company will expand its service offerings to include oligonucleotide API development and manufacture.

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

The pen injectors will be produced at Catalent’s Brussels, Belgium facility.

Curida will manufacture PCI Biotech’s Amphinex, a drug used to treat bile duct cancer.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

The company opened a new service center in San Juan, Puerto Rico.

The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.

The company will invest €18 million in its Kaysersberg facility to expand blow-fill-seal capacity.

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.