Contract manufacturer PiazaBio announces services for Western Pharma companies seeking to enter the China market.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

Through the Glycoscience Program, the National Institute of Health will contribute $10 million to advance the study of carbohydrates and the compounds that interact with them.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

The new facility will house the company’s expanding R&D operations.

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

The PDA report discusses qualification and operational handling of passive thermal protection systems.

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.

Merck Millipore’s collaboration with celares GmbH launches pegylation services for protein-based therapeutics.

Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.

FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.

In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.

Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.

The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.

The results from an international study on nivolumumab, published in the New England Journal of Medicine, suggest a paradigm shift in the standard of care for previously treated lung cancer patients.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

Pharma development and manufacturing firm Patheon announces new tagline and logo.

The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.