People and Places in the News
- By BSTQ Staff
Expansions
FDA has approved Merck’s new class of cancer drugs, Keytruda, for patients with advanced melanoma who have exhausted other therapies. Keytruda was given accelerated approval, allowing it to reach the market without the three typical phases of clinical trials needed to show a drug can prolong lives.
Facility
Australian specialty biotechnology firm CSL has opened the CSL Behring biotechnology manufacturing facility in Broadmeadows, Melbourne. The new facility will be used for producing novel recombinant therapies on a large scale for international clinical trials. CSL’s recombinant factor development programs, which include the AFFINITY trial and the PROLONG trial for the study of therapies to treat hemophilia A and B, respectively, are central to its long-term growth plans. The company said that several candidates in these trials are showing promise, including rVIII-SingleChain, rIX-FP, and rVIIa-FP. The company has more recently developed specialist capabilities in recombinant-based research, adding to its long-standing expertise in plasma protein therapeutics. Currently, the company’s R&D pipeline includes recombinant therapies for a range of rare and serious diseases, including bleeding disorders, inflammatory conditions and cancer. The first therapy to be manufactured in the new facility will be a novel blood clotting factor (rVIIa-FP) for the treatment of hemophilia. The company expects to start clinical trials of rVIIa-FP in patients later in 2014 in the U.S., Europe and Australia.