PCG PG&E restored power to more than 228,000 of the approximately 345,000 customers impacted by the Public Safety Power Shutoff, or PSPS, that started Sunday morning on October 25. PG&E crews began restoring power to customers where no damage or hazards to electrical equipment were found during inspections that began as early as Monday morning in locations where the weather "all clear" was received. In areas where equipment was damaged by the severe wind event, crews worked safely and as quickly as possible to make the repairs and restore those customers. Due to continuing high winds and dynamic weather conditions, the weather "all clear" notification for the remaining impacted areas was issued. Following this all clear, PG&E crews are now beginning power restoration efforts in areas that are still out of power. These remaining customers are expected to have power back on by late Tuesday evening or early Wednesday morning. PG&E crews will have patrolled over 17,000 miles of transmission and distribution lines for damage or hazards before all customers have been restored. The patrol and inspection efforts include nearly 1,800 ground patrol units, 65 helicopters and one airplane. Preliminary data shows at least 36 identified instances of weather-related damage and hazards in the PSPS-affected areas. Examples include downed lines and vegetation on power lines. If PG&E had not de-energized power lines, these types of damage could have caused wildfire ignitions. PSPS Restoration

PFE 🕒 пт, 18 сент. 2020 г., 12:20:58 MSK Pfizer, EMD Serono announce publication of JAVELIN Bladder 100 study results EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology, or ESMO, virtual congress 2020 and describe the efficacy of Bavencio as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma, or UC, and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the FDA approved Bavencio for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results. In the JAVELIN Bladder 100 study, Bavencio plus best supportive care, or BSC, significantly extended overall survival, or OS, compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+ and significantly more patients who received Bavencio as first-line maintenance were alive at one year. The clinical benefits of Bavencio were seen across a range of patient populations. In the JAVELIN Bladder 100 study, OS was significantly longer with Bavencio plus BSC compared to BSC alone in the primary population of all randomized patients whose disease had not progressed on first-line platinum-containing chemotherapy. Median OS was 21.4 months vs 14.3 months, respectively. At one year, 71.3% of patients in the Bavencio arm were alive vs 58.4% of patients who received BSC alone. In the other primary population of patients with PD-L1+ tumors OS was also significantly longer with Bavencio plus BSC vs BSC alone. At one year, 79.1% of patients who received Bavencio were alive vs 60.4% in the BSC arm. All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy. Results of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of Bavencio first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows: 0.69 for complete or partial response and 0.70 for stable disease. With regard to first-line chemotherapy regimen, hazard ratios were as follows: 0.69 with gemcitabine plus cisplatin and 0.66 with gemcitabine plus carboplatin. Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting. Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 and patient-reported outcomes are featured in an on-demand e-poster display.

ZYNE 🕒 чт, 17 сент. 2020 г., 20:56:35 MSK Zynerba granted orphan status for 22q11.2 deletion syndrome Zynerba Pharmaceuticals announced that the Food and Drug Administration has granted orphan drug designation for cannabidiol for use in treating 22q11.2 deletion syndrome. 22q is a rare midline condition featuring physical abnormalities and debilitating neuropsychiatric and behavioral symptoms including anxiety, withdrawn behavior, and social interaction problems, the company said. "We are pleased that the FDA shares our sense of urgency regarding the development of effective therapeutics in this important patient population. The receipt of this designation represents another important milestone for us, and we look forward to working closely with the FDA to develop Zygel in pediatric and adolescent patients with 22q as expeditiously as possible," added CEO Armando Anido.