Industry News

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 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.

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.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

CPhI China is expected to bring together approximately 35,000 attendees from more than 120 countries worldwide.

The agency extends the indication of the drug in combination with bendamustine.

The agency holds a workshop to strengthen collaboration with healthcare providers.

The company voluntarily recalls product due to particulate matter.