News

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.

A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.

Biogen, Sobi, and the World Federation of Hemophilia collaborated to enable a sustained humanitarian supply of hemophilia treatment to developing countries, and the first shipments have begun to arrive.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

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.

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

The Bothell, WA location will help the company reach its goal of expanding its global capacity by more than 30,000 liters.

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

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.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies. JLL’s 2015 Life Sciences Outlook report highlights global clusters worth watching.

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.

The National Biologics Manufacturing Centre will provide companies with open access to bioprocessing facilities and expertise to expedite low-risk market entry of complex biologics.

The project seeks to index the properties of various proteins in solution and create a home for data on the performance of product excipients with their active substances.

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.

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

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

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.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

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.

MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.

US Compounding, Inc. issues voluntary recall of all sterile products.