News

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 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.

Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.

The assay will provide information on biosimilar comparability.

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