Industry News

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

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

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

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

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

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.

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

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

The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.

The agency published a report on fostering the development of advanced therapy medicinal products.

FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.

FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.

The AAPS Foundation presented five graduate students each with a $10,000 fellowship for their research in the pharmaceutical sciences.

The United States Geological Survey study detected one or more pharmaceuticals in 59 streams throughout the Southeast United States.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Cell and Gene Therapy Catapult and the Australian CRC for Cell Therapy Manufacturing will collaborate on a project to test technology for T-cell stimulation and expansion.

The company recalls products due to sterility concerns.

The agency detailed its 2015 achievements in an annual report.

The NIH and partners will launch a large-scale clinical trial in South Africa to evaluate the effectiveness of an HIV vaccine regimen

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Biomedical innovation legislation may stall in 2016.

The updated guidelines detail best practices for conducting research with human embryonic stem cells.

Drug manufacturing lapses undermine NIH research programs.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.