Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.

The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

The agency provides quality, development, manufacturing, and labeling recommendations.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.

The ambr 250 is a mini bioreactor system for parallel fermentation or cell culture.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The company will be exhibiting at the 2016 International Fuel Ethanol Workshop and Expo.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.

The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.