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.

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The agency releases five draft guidance documents related to drug compounding and repackaging.

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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.

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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.

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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.

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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.