Lonza and Agennix have signed a development and manufacturing contract for the production of talactoferrin, an oral dendritic cell-mediated immunotherapy to treat nonsmall-cell lung cancer. Under the agreement, Lonza will produce commercial material at its microbial manufacturing facility in Kourim, Czech Republic. This agreement initiates the process for Lonza as a second manufacturer of talactoferrin after the initial commercial launch. Read More

Advertisement: Podcast - Process Validation for Sterile Manufacturing Join William (JR) Humbert, the Validation Manager at Cook Pharmica, as he discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.

Merck & Co. and Endocyte have agreed to develop and commercialize the Phase III cancer candidate vintafolide. Under the agreement, Merck, through a subsidiary, will gain worldwide rights to develop and commercialize vintafolide. Endocyte will receive a $120-million upfront payment and is eligible for milestone payments of up to $880 million based on the successful achievement of development, regulatory, and commercialization goals for vintafolide for a total of six cancer indications. If vintafolide receives regulatory approval. Endocyte has retained the right to copromote vintafolide with Merck in the US and Merck has the exclusive right to promote vintafolide in the rest of world. Endocyte will be responsible for the majority of funding and completion of the Proceed trial. Merck will be responsible for all other development activities and costs and have all decision rights for vintafolide. Endocyte remains responsible for the development, manufacture, and commercialization worldwide of etarfolatide, a noninvasive companion diagnostic imaging agent that is used to identify folate receptor positive tumor cells. Read More

Advertisement: Making Sense of Excipient Performance for Quality by Design (QbD) Live Webcast: Thursday, April 19, 2012 at 10:00 EST, 15:00 GMT, 16:00 CET, 20:30 IST. Register Free at http://www.pharmtech.com/excipient

West Pharmaceutical Services has introduced a new line of components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates quality by design principles. The pure components, include serum and lyophilization stoppers and syringe plungers.

Advertisement: What's the matter with Sample Prep? - Novel approaches and solutions Live Webcast: Tuesday, April 24, 2012 at 11:00 AM EDT Register Free at http://www.pharmtech.com/sample

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More