Baxter files PLA and ELA for the recombinant Factor VIII product for prevention and control of bleeding episodes in individuals with hemophilia A, Baxter said May 3. Recombinate was developed by Genetics Institute and is licensed to Baxter on an exclusive, worldwide basis. Last year, Genetics Institute and Genetech, which is developing a Factor VII for marketing by its licensee Miles through its Cutter Biological business, avoided a court patent battle by entering a cross-licensing arrangement for the product ("The Pink Sheet" March 27, 1989, p. 5). Baxter's Hyland Division will eventually market Recombinate.
You may also be interested in...
Can a false-claims suit be filed if doctors have different opinions about whether a treatment was necessary? The Supreme Court won’t say.
No device-related close-out letters were released by the US FDA last month.
The pharmaceutical industry and other stakeholders have taken part in the launch event for a new initiative intended to tackle issues that have been amplified by the COVID-19 pandemic, such as supply chain resilience and medicine shortages. The project has drawn a mixed response from industry bodies.