First Hospira Biosimilar mAb Approved in West Europe
Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

FDA Announces Approval of Lenvima for Differentiated Thyroid Cancers
FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

Advertisement: The 2015 PDA Annual Meeting offers the most concentrated education and networking opportunities with leading industry experts focused on Bio/Pharmaceutical science, manufacturing technology, quality and evolving regulations. It will provide a look into the future of manufacturing and the actions necessary today to prepare for the changes of tomorrow. Extend your learning with the post-conference Aging Facilities Workshop and Course Series

FDA Issues Guidance on Drug Compounding
The agency releases five draft guidance documents related to drug compounding and repackaging.

New Financial Strategies Needed to Support Biomedical Innovation
The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

Genzyme Announces $845-Million Gene Therapy Deal
Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

Romaco Group Announces Finalization of Innojet Acquisition
Romaco Group announced that it finished the acquisition of Innojet Herbert Hüttlin, a German company specializing in coating and granulation.

PCI Completes Full Biotec Rebranding
Five months after PCI acquired Biotec International Services, PCI has completed a complete rebranding of the UK-based Biotec.

Pfenex Announces Partnership with Hospira to Develop Lucentis Biosimilar
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

CDER and Biotech Quality Assessment
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

Advertisement: Developing a Comprehensive Tool Kit for Microbial Identification On Demand Click here to Register free.

Advertisement: Enhancing Quality and Process Efficiency using Continuous Manufacturing Technology for Drug Substance and Drug Product On Demand Click here to Register free.

Advertisement: Pharma Supply Chain Security: Are You in Control? Live webcast: February 25, 2015 at 11AM ET In this program, an expert shares best practices that will prevent liability and noncompliance, improve quality and boost supply chain efficiency. Register free www.pharmtech.com/security

Advertisement: Fundamentals of Spray-Dried Dispersion Technology Live broadcast on: March 19th, 2015 at 11AM ET Spray-dried dispersion technology is a proven approach to improve the dissolution rate and bioavailability of low solubility compounds, and helps to bring new medicines to market. Attend this webinar to learn the fundamentals of spray-dried dispersion formulation selection, process development, stability, scale-up, and performance considerations. Register free www.pharmtech.com/spray