• Pfizer Inc., of New York, said the FDA granted regular approval for Xalkori (crizotinib) for use in patients with metastatic ALK-positive non-small-cell lung cancer as detected by an FDA-approved test. Xalkori previously gained accelerated approval in August 2011.
• Pfizer Inc., of New York, said it entered an agreement with Glaxosmithkline plc, of London, to explore the anticancer efficacy and safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study in patients with advanced/metastatic melanoma.
• D-Pharm Ltd., of Rehovot, Israel, said it received approval from regulatory authorities in Slovakia to start a Phase II study testing DP-b99 in patients with acute high-risk inflammation of the pancreas. The trial will enroll about 30 patients who will be treated twice daily with either DP-b99 or placebo and followed up using clinical assessment scales, by monitoring inflammatory biomarkers and with abdominal imaging.
With the sequestration blade set to indiscriminately shave federal programs again in January, a bipartisan group of senators is urging congressional budget negotiators to spare research dollars at the National Institutes of Health (NIH).
Scientists have shown that inhibiting mTOR more than doubled the life expectancy of mice with Leigh syndrome, a disease that is most often fatal in children by the time they reach school age.
• Galapagos NV, of Mechelen, Belgium, said its Biofocus subsidiary signed a new collaboration agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to apply its drug discovery services to an undisclosed target within Boehringer’s drug discovery portfolio. Financial terms were not disclosed.
• Cytrx Corp., of Los Angeles, said it started a Phase II study of aldoxorubicin for the treatment of unresectable glioblastoma multiforme whose tumors have progressed following prior treatment with surgery, radiation and temozolomide.
• CSL Ltd., of King of Prussia, Pa., presented data at the American Heart Association meeting in Dallas showing that CSL112 demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease and showed a dramatic and rapid increase in key biomarkers of reverse cholesterol transport.