Biologic Drugs

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

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.

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

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.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

The agency has recommended granting marketing authorization for Opdivo.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.

In this article, industry experts discuss critical analyses for demonstrating biosimilarity.

FDA approves a biosimilar and loses a commissioner in March.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.

Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

WuXi's new facility in Philadelphia will manufacture CAR T-cell therapies and other cancer immunotherapies.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Baxter has bought SuppreMol, a German biopharmaceutical company that focuses on autoimmune treatments, for €200 million ($225 million USD).

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

A facility expansion adds space for production of Repligen’s tangential flow system.

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.