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The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

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.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

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

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.

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 committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

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.

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

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.

FDA said in briefing documents ahead of a July 13, 2016 meeting that Sandoz’s biosimilar GP2015 has “no clinically meaningful differences” with the US-licensed and EU-licensed versions of Enbrel (etanercept) in terms of safety, purity, and potency.

Cancer cell lines could provide viable pathways to determining how tumors respond to specific anti-cancer drugs.

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.