Quality/GMPs

The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The company is voluntarily recalling product because of glass particles found in vials.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the November 2018 US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.

Scientific advances and renewed investment may infuse biopharma for growth.

Gene therapies highlight FDA new drug approvals in 2017.

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.

Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.