Quality/GMPs

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

Will biosimilars share a compendial identity like generic drugs do?

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.

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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.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