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

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.

Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.

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

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.

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.

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.

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

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