Quality/GMPs

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.

Supply chain consortium establishes a working group to address quality problems in India.

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

Johnson & Johnson announces partnership with NYU School of Medicine to launch a compassionate care committee for individual patient requests of investigational drugs.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

The company voluntarily recalls select lots of Adrucil due to particulate matter.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

The Australian pharmaceutical market offers opportunities for manufacturers despite challenges.

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

The biopharma industry has had some successes but still needs to work on operational issues.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

The agency has recommended granting marketing authorization for Opdivo.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

The European Medicines Agency releases findings from marketing authorization application analysis.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.