From Bureau of Reclamation:
Reclamation Announces Initial Water Supply Allocation for the Central Valley Project.https://on.doi.gov/2mHrVEw
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Tuesday, February 28, 2017
Snow in Northern Arizona and Travel
Traveling today? Northern #Arizona received a blanket of snow last night. Best to travel this afternoon. Let ice soften & crews plow roads. pic.twitter.com/3Sj6hbNnkg
Road has Reopened
#NationalPark
#GrandCanyon Rd Update: Desert View Dr. Hwy 64 (Yaki Point to Desert View) has reopened. Hermit Rd remains closed at this hour @ArizonaDOT pic.twitter.com/ew29SSl7Bf
Great Falls Park
From U.S. Department of the Interior:
Just outside of Washington, D.C., in Virginia, Great Falls Park is the perfect place to get some exercise. There’s hiking, biking, fishing, climbing and boating opportunities. But, however fast you’re moving, the stunning view of the Potomac River crashing over the falls will stop you in your tracks. Sunrise photo courtesy of Jose Torres. — withjosetorresphoto.com at Great Falls Park.
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Just outside of Washington, D.C., in Virginia, Great Falls Park is the perfect place to get some exercise. There’s hiking, biking, fishing, climbing and boating opportunities. But, however fast you’re moving, the stunning view of the Potomac River crashing over the falls will stop you in your tracks. Sunrise photo courtesy of Jose Torres. — withjosetorresphoto.com at Great Falls Park.
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Kenai Fjords National Park
A7. #FindYourPark Take a boat tour into the #fjords for tidewater #glaciers or hike at #ExitGlacier. #TravelAlaskaChat pic.twitter.com/6yjdRXOFru
Grand Canyon National Park (98 Years Old)
Yesterday @GrandCanyonNPS turned 98 years old. Here’s a stunning pic by Cat Connor to celebrate this #Arizona icon https://on.doi.gov/2l7TlTb pic.twitter.com/mjngaIdx4t
Monday, February 27, 2017
Grand Coulee Dam | Washington State
From Bureau of Reclamation:
Because the Grand Coulee Dam in Washington State #WA is our #DamOfTheWeek, we invite you to enjoy this photograph by Bureau of Reclamation Hydrologic Technician Craig Brougher, which shows the backside of Grand Coulee Dam, with Lake Roosevelt on the right, above the dam; and Rufus Woods Lake on the left, below the dam, both of which are part of the Columbia River.
The town of Coulee Dam is actually split into two communities on opposite sides of the river, Engineers Town with its Maple Trees showing their Fall colors, and Mason City across the bridge. Both communities were incorporated in 1959 into the town of Coulee Dam.
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Because the Grand Coulee Dam in Washington State #WA is our #DamOfTheWeek, we invite you to enjoy this photograph by Bureau of Reclamation Hydrologic Technician Craig Brougher, which shows the backside of Grand Coulee Dam, with Lake Roosevelt on the right, above the dam; and Rufus Woods Lake on the left, below the dam, both of which are part of the Columbia River.
The town of Coulee Dam is actually split into two communities on opposite sides of the river, Engineers Town with its Maple Trees showing their Fall colors, and Mason City across the bridge. Both communities were incorporated in 1959 into the town of Coulee Dam.
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Facing the work week can be tough
From Rocky Mountain National Park:
Monday Motivation:
Facing the work week can be tough. Before you bury your head in work, though, remember that studies show getting outdoors can boost creativity and focus and improve your mood and self-esteem. Have a great week!
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Monday Motivation:
Facing the work week can be tough. Before you bury your head in work, though, remember that studies show getting outdoors can boost creativity and focus and improve your mood and self-esteem. Have a great week!
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Grand Coulee Dam
From Bureau of Reclamation:
Happy Monday Everyone! This week we are celebrating the Pacific Northwest Region, and highlighting Grand Coulee Dam as our #DamOfTheWeek. Stay tuned all week for great Grand Coulee photographs and information.
This Aerial photograph of Grand Coulee Dam was taken by Craig Brougher during the 2015 annual shoreline investigation of Lake Roosevelt. Grand Coulee Dam is in the foreground and Steamboat Rock and Banks Lake are in the background.
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Happy Monday Everyone! This week we are celebrating the Pacific Northwest Region, and highlighting Grand Coulee Dam as our #DamOfTheWeek. Stay tuned all week for great Grand Coulee photographs and information.
This Aerial photograph of Grand Coulee Dam was taken by Craig Brougher during the 2015 annual shoreline investigation of Lake Roosevelt. Grand Coulee Dam is in the foreground and Steamboat Rock and Banks Lake are in the background.
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Natural Wonder at Yellowstone National Park
From Yellowstone National Park:
From 1839: "The water was of deep indigo blue boiling like an imense cauldron running over the white rock..." True? pic.twitter.com/JvWUAx2rhm
Spirit Mound
From Lewis and Clark National Historic Trail:
One of the few remaining physical features that’s easily identified as a place where Lewis and Clark actually stood is Spirit Mound. In August 1804, the two captains, several men and Seaman walked about nine miles from their camp on the Missouri River near the mouth of White Stone Creek. The explorers were determined to see for themselves the mound that was so feared by the Indians of the area.
Clark wrote, “…in this quarter is Suppose to be the residence of Deavels. That they are in human form with remarkable large heads, and about 18 inches high, that they are very watchful and are arm’d with Sharp arrows with which they Can Kill at a great distance…”
No devils were found when the party finally reached the top of Spirit Mound. Instead, the men “beheld a most beautiful landscape; Numerous herds of buffalo were seen feeding in various direction…as far as can be seen”.
You can visit Spirit Mound – it’s approximately six miles north of Vermillion, South Dakota on state highway 19, in Spirit Mound Historic Prairie. Over 300 acres of prairie are being restored to original grasses and there’s a 0.75-mile hiking trail to the summit. More details can be found athttp://gfp.sd.gov/ state-parks/directory/ spirit-mound/.
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One of the few remaining physical features that’s easily identified as a place where Lewis and Clark actually stood is Spirit Mound. In August 1804, the two captains, several men and Seaman walked about nine miles from their camp on the Missouri River near the mouth of White Stone Creek. The explorers were determined to see for themselves the mound that was so feared by the Indians of the area.
Clark wrote, “…in this quarter is Suppose to be the residence of Deavels. That they are in human form with remarkable large heads, and about 18 inches high, that they are very watchful and are arm’d with Sharp arrows with which they Can Kill at a great distance…”
No devils were found when the party finally reached the top of Spirit Mound. Instead, the men “beheld a most beautiful landscape; Numerous herds of buffalo were seen feeding in various direction…as far as can be seen”.
You can visit Spirit Mound – it’s approximately six miles north of Vermillion, South Dakota on state highway 19, in Spirit Mound Historic Prairie. Over 300 acres of prairie are being restored to original grasses and there’s a 0.75-mile hiking trail to the summit. More details can be found athttp://gfp.sd.gov/
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Sunday, February 26, 2017
Sunset near the Snake Creek Pumping Plant
From Bureau of Reclamation:
Let's finish this #weekend right with a #cool #photo of a #sunset taken by Reclamation's Martin Malachowski near the Snake Creek pumping plant in #ND. Learn more herehttps://on.doi.gov/2mcR9yF
#photooftheday #sunsetsunday
Let's finish this #weekend right with a #cool #photo of a #sunset taken by Reclamation's Martin Malachowski near the Snake Creek pumping plant in #ND. Learn more herehttps://on.doi.gov/2mcR9yF
#photooftheday #sunsetsunday
Hanging Valley
This hanging valley reminds us of a person reaching towards the sky with open arms giving Bridalveil Fall a welcoming and familiar feel. pic.twitter.com/fUm31L0fzJ
Pictured Rocks National Lakeshore
From Midwest National Parks:
"Look around. Look at what we have. Beauty is everywhere—you only have to look to see it.” - Bob Ross
Pictured Rocks National Lakeshore #MidwestNPS
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"Look around. Look at what we have. Beauty is everywhere—you only have to look to see it.” - Bob Ross
Pictured Rocks National Lakeshore #MidwestNPS
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Denali National Park and Preserve
From U.S. Department of the Interior:
On this day in 1917, Denali National Park and Preserve was established. While we celebrate the 100th anniversary of this area’s scenic beauty, Denali’s rich history dates back much further. For thousands of years, Alaska Natives have lived on the land surrounding the Denali area and used the resources of the land for food, shelter and trade. Today the park preserves a diverse tapestry of plant life and intact ecosystems where bears, wolves, caribou, moose and Dall sheep roam as they have for thousands of years. Photo by National Park Service. — at Denali National Park and Preserve.
On this day in 1917, Denali National Park and Preserve was established. While we celebrate the 100th anniversary of this area’s scenic beauty, Denali’s rich history dates back much further. For thousands of years, Alaska Natives have lived on the land surrounding the Denali area and used the resources of the land for food, shelter and trade. Today the park preserves a diverse tapestry of plant life and intact ecosystems where bears, wolves, caribou, moose and Dall sheep roam as they have for thousands of years. Photo by National Park Service. — at Denali National Park and Preserve.
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Saturday, February 25, 2017
Turquoise Lake
From Bureau of Reclamation:
Happy #Scenic #Saturday! Check out this #cool#photo of #TurquoiseLake near #SugarloafDam in#Colorado, taken by Reclamation's David Hartman.
Learn more about Sugarloaf Dam here:https://www.usbr.gov/gp/ hydromet/turq.html
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Happy #Scenic #Saturday! Check out this #cool#photo of #TurquoiseLake near #SugarloafDam in#Colorado, taken by Reclamation's David Hartman.
Learn more about Sugarloaf Dam here:https://www.usbr.gov/gp/
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Lake Sherburne Reservoir
From Bureau of Reclamation:
It's #Scenic #Saturday in Reclamation's Great Plains Region. Check out this #beautiful #photo of#LakeSherburne Reservoir located in #Montana, taken by Reclamation's Gail Chopp.
Learn more about Lake Sherburne here:https://on.doi.gov/2lwRDfF
It's #Scenic #Saturday in Reclamation's Great Plains Region. Check out this #beautiful #photo of#LakeSherburne Reservoir located in #Montana, taken by Reclamation's Gail Chopp.
Learn more about Lake Sherburne here:https://on.doi.gov/2lwRDfF
Landslide, Highway 12
From Bryce Canyon National Park:
Following spring-related landslide, Hwy 12 near Mossy Cave reduced to 1 lane metered traffic. Expect 3 min delays. pic.twitter.com/S6oCEYqEia
Friday, February 24, 2017
UPS Accelerates Transformation Of Its Smart Logistics Network
UPS® (NYSE:UPS) today provided an update to its multi-year growth strategies, transportation and operations network transformation, and provided long term financial targets during the company’s investor conference in New York City.
Senior executives discussed topics central to the theme of the conference; Invest. Grow. Deliver. The company’s plans include:
UPS Accelerates Transformation Of Its Smart Logistics Network
Give Your Business a Boost with the FedEx Small Business Grant Contest
Inspiring small businesses are being recognized and rewarded every year. Share what inspired you and your core mission and you could be the next winner.
Entering its fifth year, the FedEx Small Business Grant Contest awards tens of thousands of dollars to passionate small business owners across the country.
Give Your Business a Boost with the FedEx Small Business Grant Contest
Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration
From Pfizer:
Pfizer Announces Acceptance of Regulatory Submission for Inotuzumab Ozogamicin by the U.S. Food and Drug Administration
Application Requests Approval for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
Tuesday, February 21, 2017 8:00 am EST
Dateline:
NEW YORK
Public Company Information:
NYSE:
PFE
US7170811035
"Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL."
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2017.
“ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.”
In addition, a Marketing Authorization Application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agency (EMA).
The submissions are based on results from the Phase 3 INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. The INO-VATE 1022 study had two independent primary endpoints, complete response with or without hematologic remission (CR/CRi) and overall survival (OS). Results from the trial were published in The New England Journal of Medicine in June 2016.
About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.1 The current foundational treatment is intensive, long-term chemotherapy.2 In 2017, it is estimated that 5,970 cases of ALL will be diagnosed in the United States, with about 2 in 5 cases occurring in adults.3 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.4 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.5
About Inotuzumab Ozogamicin
Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent.6 When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.7 The most common adverse events (AEs) observed in clinical trials for inotuzumab ozogamicin were cytopenias, including febrile neutropenia. Common nonhematologic treatment-emergent AEs with inotuzumab ozogamicin included nausea, headache and pyrexia. Additionally, veno-occlusive liver disease (VOD) was observed more frequently in patients treated with inotuzumab ozogamicin, especially those who went on to receive hematopoietic stem cell transplantation.
Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives.
Pfizer Inc.: Working together for a healthier world ®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of February 21, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about inotuzumab ozogamicin, an investigational oncology therapy, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when applications for inotuzumab ozogamicin may be filed in any other jurisdictions; whether and when the BLA, MAA and any other such applications for inotuzumab ozogamicin may be approved by the FDA, the EMA or other regulatory authorities, respectively, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of inotuzumab ozogamicin; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
_______________________
1 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1. Accessed March 21, 2016.
2 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment. Accessed March 21, 2016.
3 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics . Accessed January 26, 2017.
4 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147.
5 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950.
6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334.
7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.
2 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment. Accessed March 21, 2016.
3 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics . Accessed January 26, 2017.
4 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147.
5 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950.
6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334.
7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.
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