BioPharm International Editors

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

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

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

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

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

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

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

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

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

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.

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

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

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 acquired kSep Holdings, a single-use bioprocessing solutions company.

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.

A study shows high levels of ADAs to infliximab at the beginning of treatment were associated with a poor response later on.

International-domestic pharma partnerships will drive next wave of growth in China, according to new CPhI report on China.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

Evonik will acquire Transferra for an undisclosed amount, and the transaction is scheduled to close at the end of July 2016

A study by MilliporeSigma and the Economist Intelligence Unit reviews growth drivers and approaches to mitigate risk.