Alseres have announced that Cethrin has been granted designation as an orphan medicinal product for the treatment of traumatic spinal cord injury (SCI) by the European Commission.
Filed under: Uncategorized | Tagged: Alseres, Cethrin, kinase, regulatory, Rho, Rock | Comments Off
Merck Serono has submitted an EMEA application for Erbitux (cetuximab) for use in the firstline treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC).
Filed under: Uncategorized | Tagged: BMS, cetuximab, erbitux, HER1, ImClone, Merck KGaA, Merck-Serono, regulatory | Comments Off
Novartis have announced that RAD001 (everolimus) has been granted priority review by the US FDA for the treatment of patients with advanced kidney cancer after failure of standard treatment. Marketing authorization applications for RAD001 have also been filed with the EMEA and Swissmedic. The proposed brand name for RAD001 is Afinitor
Filed under: kinase | Tagged: Afinitor, everolimus, kinase, mTOR, Novartis, RAD-001, RAD001, regulatory | Comments Off
Gleevec (imatinib) has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST).
Filed under: Uncategorized | Tagged: Bcr-Abl, c-kit, Gleevec, Glivec, Imatinib, Novartis, PDGF, regulatory | Comments Off
Roche have issued a statement saying it won’t lower the price for Avastin despite UK’s NICE ruling that it is not a cost-effective treatment for advanced and/or metastatic renal cell carcinoma. Roche argue that Avastin is used in many cancer types and is fully reimbursed in most European countries.
Pfizer, Bayer and Wyeth are still considering their formal [...]
Filed under: kinase | Tagged: Avastin, bevacizumab, Genentech, kinase, NICE, regulatory, Roche, VEGF | Comments Off
The UK’s National Institute for Health and Clinical Excellence (NICE) has made a preliminary ruling stating that Avastin, Nexavar, Sutent and Torisel are not effective enough to warrant their high cost and shouldn’t be prescribed to new patients in Britain.
Filed under: Kinase receptor, kinase | Tagged: Avastin, bayer, bevacizumab, Genentech, kinase, mTOR, multikinase, Nexavar, onyx, Pfizer, regulatory, Roche, sorafenib, SU-11248, SU11248, sunitinib, sutent, temsirolimus, torisel, VEGF, Wyeth | Comments Off
SuperGen have announced that the U.S. FDA has granted orphan drug designation for the company’s lead drug candidate, MP-470 in the the treatment of glioblastoma multiforme. MP-470 inhibits c-MET, c-RET, c-KIT, PDGFR and FLT3
Filed under: Uncategorized | Tagged: c-kit, c-met, c-RET, ckit, cmet, cret, FDA, FLT3, MP-470, mp470, PDGFR, regulatory, Supergen | Comments Off
Bayer and Onyx have announced that Nexavar has been approved for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer in China
Filed under: kinase | Tagged: Approval, bayer, kinase, multikinase, Nexavar, onyx, regulatory, sorafenib | Comments Off
Merck Serono have received EU approval for Erbitux in EGFR expressing, KRAS wild-type metastatic colorectal cancer
Filed under: Kinase receptor | Tagged: Approval, BMS, cetuximab, erbitux, HER1, ImClone, Merck KGaA, Merck-Serono, regulatory | Comments Off
ImClone Systems have announced that Erbitux (cetuximab) has been approved in Japan for use in treating patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent CRC, and allows the use of ERBITUX plus irinotecan in second and further lines of mCRC. With this approval, ERBITUX is the first ever EGFR-targeted monoclonal [...]
Filed under: Kinase receptor | Tagged: Approval, BMS, cetuximab, erbitux, HER1, ImClone, Merck KGaA, Merck-Serono, regulatory | Comments Off
