Biologic Drugs

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Dual sourcing is one of many possible solutions to securing the supply chain.

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.

Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.

Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

Amgen is suing Sandoz over Sandoz's biosimilar application for filgrastim.

Sigma-Aldrich's custom manufacturing services business unit, SAFC, has launched a new protein quality supplement for biological drug production, including biosimilars.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

Demand for new therapies and vaccines spotlights production challenges.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Customers are looking to reduce risk, increase performance, and optimize productivity.

With a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

New International Council on Biotechnology Associations advocates biotechnology growth.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.