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news.FDA advisory committee recommends Lev’s Cinryze
The FDA will review the advisory committee’s recommendations in connection with its consideration of Lev’s biologic license application (BLA). Joshua Schein, CEO of Lev, said: “The advisory committee’s
The FDA will review the advisory committee’s recommendations in connection with its consideration of Lev’s biologic license application (BLA). Joshua Schein, CEO of Lev, said: “The advisory committee’s
The trial is projected to enroll approximately 100 adult patients at 20 sites in the US. The study will evaluate the safety and efficacy of PZ-601 in patients
Recent improvements to the recombinant protective antigen (rPA) vaccine, specifically related to stability, suggests that it is well positioned to be a leading candidate for an award under
The application is based on data from the Phase III Interest study, which showed that patients with pre-treated advanced non-small cell lung cancer (NSCLC) who received gefitinib had
Erbitux was approved by Health Canada in September 2005. But owing to disagreement over the drug price with the Patented Medicine Prices Review Board (PMPRB), a quasi-judicial body
In fiscal year 2008 alone, the FDA is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act
Under the terms of the agreement, Arrow is entitled to receive $500,000 upon execution of the agreement and future payments of up to $70 million. Arrow will also
Under the terms of the agreement, the company will receive an upfront payment of $1 million with the remaining $3.1 million due when the company vacates the premises
The study evaluated symptomatic progress of US patients involved in the company’s two Phase I/II studies initiated in 2003. Patients treated with NX-1207 were followed-up on an unselected
Bovie intends to finalize the development and commercialization of the technology. As part of the agreement, Bovie granted a license to Boston Scientific until 2016 to uses outside