Amgen’s Xgeva shows Mixed results compared to Zoledronic Acid-Results from a Phase 3 study evaluating Amgen’s $AMGN XGEVA (denosumab) compared to zoledronic acid (ZA) for the prevention of bone complications in a newly diagnosed multiple myeloma (MM) patients, succeeded in attaining primary endpoints. Full results of the clinical trial will presented at the future medical conference and for publication. The data will also be submitted to regulatory authorities. The primary endpoint was a non-inferiority test defined by the time to the first skeletal-related event (SRE). However, the treatment failed to show any superiority over ZA as the secondary endpoints were not met.
Gilead triple combo pill for genotypes 1-6 chronic hepatitis c virus show high cure rate-Gilead Sciences $GILD reported strong results from four international Phase 3 clinical studies (POLARIS-1, -2, -3, -4) evaluating its investigational once-daily, fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX) for the treatment of genotypes 1-6 chronic hepatitis c virus (HCV) infection. Complete results will be submitted in November at The Liver Meeting in Boston.
Gilead Sciences’ $ open label Phase 2 clinical trial evaluating GS-4997 (selonsertib), taken alone or in combination with simtuzumab (SIM) for the treatment of patients with non-alcoholic steatohepatitis (NASH) with moderate-to-severe liver fibrosis showed a positive treatment benefit. The top-line data will be submitted at the Liver Meeting in Boston, between November 11 and 15, 2016.
Omeros’ OMS721 successful in mid-stage trial in HSCT-associated small vessel blood clots-Omeros $OMER announced positive results from a Phase 2 clinical development study evaluating lead product candidate, OMS721 for the treatment of patients who have thrombotic microangiopathy (TMA) associated with a hematopoietic stem cell transplant (HSCT), a condition with a high mortality rate. TMA signals that there is a damage in the smallest blood vessel and blood clots are involved.
NHS Issues Positive appraisal for Celgene’s Otezla-England’s National Institute for Health and Care Excellence (NICE), an advisory group to the National Health Service (NHS) on costs and quality, issued a positive final appraisal determination providing patient access to Celgene’s $CELG OTEZLA (apremilast) for the treatment of chronic plaque psoriasis. As a result, patients in England and Wales will now have access to OTEZLA. The drug was available in Scotland since June 2015.
Theravance and Mylan announce encouraging results from late-stage COPD candidate- Theravance $TBPH and development partner Mylan N.V. $MYL reported a successful results from two replicate Phase 3 study evaluating revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Both trails met their primary endpoint of a statistically valid improvement versus placebo in trough forced expiatory volume in one second (FEV1) after 12 weeks of treatment with each dose studied (88 mcg once-daily and 176 mcg once-daily). The drug-maker plans U.S. marketing application by end of the next year.
FDA to consider Teva’s resubmitted application for deutetrabenazine- The FDA accepted Teva Pharmaceutical Industries’ $TEVA request to review a resubmitted New Drug Application (NDA) seeking approval of deutetrabenazine (SD-809) for the treatment of chorea (involuntary movements) associated with Huntington’s disease, an Orphan Drug indication. The action date is April 3, 2017. The drug-maker received a Complete Response Letter (CRL) in May regarding its original filing, requiring to re-analyze blood levels of certain metabolites.
Rigel’s fostamatinib fails late-stage trial in thrombocytopenia-Rigel Pharmaceuticals $RIGL nosedived more than 25% amid heavy trading volume in response to its announcement of failed results in the second of two Phase 3 study evaluating fostamatinib for the treatment of adult patients with chronic/persistent immune thrombocytopenia (low blood platelets). The trial, FIT 2 (Study 048), was unsuccessful in achieving its primary endpoint of a statistically valid response rate compared to placebo.