Friday, February 24, 2017

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_NewsLinkedInYouTube, 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 .
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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. 

8 Ideas to Attract Customers to Your Store on a Slow Day

This is a tough time for retailers.
You’re caught between the holiday shopping frenzy and the anticipation of spring. Bad weather in most of the country (even in Southern California where I live, it’s been pouring rain for months) tends to keep shoppers indoors. On one of those days when you’ve been open two hours without a single shopper walking through the door, how can you turn things around? Try these ideas.


8 Ideas to Attract Customers to Your Store on a Slow Day

First Comprehensive Pediatric Hematology-Oncology Initiative Launched in Africa

From Bristol-Myers Squibb:


First Comprehensive Pediatric Hematology-Oncology Initiative Launched in Africa

  • Government of Botswana announces new public-private partnership to treat children with cancer and blood disorders
  • The $100 million initiative to create a pediatric hematology-oncology treatment network and care infrastructure is supported by $50 million donation from the Bristol-Myers Squibb Foundation and matched by $50 million in additional philanthropy
  • Partnership includes Texas Children’s Cancer and Hematology Centers, Baylor College of Medicine International Pediatric AIDS Initiative at Texas Children’s Hospital and the Governments of Botswana, Uganda and Malawi

Category: 

Tuesday, February 21, 2017 3:00 am EST
NEW YORK, HOUSTON, & GABORONE, Botswana--(BUSINESS WIRE)--His Excellency the President Lieutenant General Dr. Seretse Khama Ian Khama of the Republic of Botswana, the Honorable Minister Dorcas Makgato of the Ministry of Health and Wellness, the Bristol-Myers Squibb Foundation, Texas Children’s Cancer and Hematology Centers (TXCH) and Baylor College of Medicine International Pediatric AIDS Initiative at Texas Children’s Hospital (BIPAI) through public-private partnerships with the governments of Botswana, Uganda and Malawi, announced a $100 million initiative to create an innovative pediatric hematology-oncology treatment network in southern and east Africa. The comprehensive initiative called Global HOPE (Hematology-Oncology Pediatric Excellence) will build long-term capacity to treat and dramatically improve the prognosis of thousands of children with cancer and blood disorders in southern and eastern Africa.
In the United States, 80 percent of children with cancer survive. In sub-Saharan Africa, the overwhelming majority of pediatric patients do not survive. The mortality rate is estimated to be as high as 90 percent, meaning that thousands of children die from cancer across Africa each year. This is in large part due to an inadequate healthcare infrastructure and a significant lack of expert physicians and other healthcare workers trained to treat children with cancer. The most common types of childhood cancers are blood cancers, including leukemia and lymphoma.
Global HOPE will partner with local Governments and Ministries of Health to build medical capacity to diagnose and treat pediatric blood disorders and cancer in Botswana, Malawi and Uganda. The initiative will also create significant clinical, educational and research capabilities. Doctors, nurses and ancillary professionals will be recruited from around the world to provide training to local healthcare professionals and to begin treating children with blood disorders and cancer immediately.
“This project is building on a solid foundation for pediatric cancer treatment in Botswana that began with pediatric oncologists from Texas Children’s Cancer and Hematology Centers,” said His Excellency the President Lieutenant General Dr. Seretse Khama Ian Khama of the Republic of Botswana. “The Global HOPE program will bring to Botswana the latest bio-medical technologies and the potential to work with local institutions such as the Botswana Innovation Hub and University of Botswana to quickly increase the survival of children with cancer and life-threatening blood disorders in Botswana and the region.”
The Bristol-Myers Squibb Foundation is committing $50 million over five years to fund the training of healthcare providers as well as clinical infrastructure and operations. BIPAI will raise an additional $50 million for the initiative.
“We are eager to get started on this critical initiative to help children with blood disorders and cancer. Working with our partners and drawing on our expertise of building sustainable health systems in underserved countries, we will help make a significant difference in the outcomes for children while creating a blueprint for other countries to follow,” said Giovanni Caforio, M.D., chairman of the board of the Bristol-Myers Squibb Foundation and chief executive officer, Bristol-Myers Squibb Company. “This initiative builds on 18 years of success of the Foundation’s SECURE THE FUTURE ® program and will offer new hope to families impacted by pediatric blood disorders and cancer.”
As public-private partnerships, the various governments will each play an important role in developing the pediatric hematology-oncology network, assisting with the training, technical assistance, logistics and resources to support Global HOPE.
The Global HOPE initiative will train an estimated 4,800 healthcare professionals from Botswana, Uganda, Malawi and other African countries, including doctors and nurses specializing in pediatric hematology-oncology and social workers. The program estimates that over 5,000 children will receive care in the first five years.
“With only five pediatric oncologists currently in the countries of Botswana, Malawi and Uganda combined, there are simply not enough expert doctors to treat all the children diagnosed with blood disorders and cancer. We believe in these countries there are more than 11,000 new cases annually of pediatric cancer and 40,000 new cases of serious, life-threatening blood disorders such as sickle cell disease and hemophilia. Because of these staggering numbers, more healthcare providers with special expertise are urgently needed,” said David G. Poplack, M.D., director of Texas Children’s Cancer and Hematology Centers and Professor of Pediatric Oncology at Baylor College of Medicine. “Global HOPE will help build capacity in the region to diagnose and care for children with blood disorders and cancer, offering the potential for transformational change in survivorship for these children.”
The Global HOPE initiative will be modeled on the work of the Bristol-Myers Squibb Foundation, BIPAI and the Governments of Botswana, Uganda and Malawi, which created the largest pediatric HIV treatment network in the world, leveraging existing experience, infrastructure, and public/private partnerships created through the initiative. Since 2003, the Bristol-Myers Squibb Foundation and BIPAI have trained 52,000 healthcare professionals and currently provide care for nearly 300,000 children with HIV and their families in sub-Saharan Africa, lowering the mortality rate for these children to 1.2 percent.
“The success we’ve had in radically changing the course of pediatric HIV/AIDS in sub-Saharan Africa is due in large part to the tremendous support provided by the country governments, healthcare providers on the ground and donors who have made our work possible,” said Mark W. Kline, M.D., president and founder of BIPAI, physician-in-chief of Texas Children’s Hospital and chair of the Department of Pediatrics at Baylor College of Medicine. “We look forward to helping patients and their families by embarking on this unchartered area of cancer care in Africa. Working with our partners, we aim to build a self-sustaining infrastructure that changes the tide of these childhood diseases in sub-Saharan Africa.”
About the Republic of Botswana and the Ministry of Health and Wellness
Botswana is a country with two million inhabitants in southern Africa with abundant and diverse natural resources. The official languages are English and Setswana. Since independence in 1966, Botswana has been a parliamentary republic; the chief of state and head of government is the president. Botswana’s economy is a success story in southern Africa due to the investment of the government in the education, health, clean water and telecommunications sectors to create a better standard of living for its citizens and to foster a conducive environment for free enterprise to prosper.
The Ministry of Health and Wellness aims to improve the physical, mental, and social well-being of every citizen of Botswana to fully contribute to the development of Botswana through a healthy nation.
About the Bristol-Myers Squibb Foundation
The Bristol-Myers Squibb Foundation is committed to improving the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services, and addressing unmet medical need. The Foundation engages partners to develop, execute, evaluate and promote innovative programs to help patients with lung cancer and removing barriers to accessing care in the United States, HIV and comorbid diseases such as cervical and breast cancers and tuberculosis in sub-Saharan Africa, hepatitis B and C in China and India and veterans’ mental health and well-being in the U.S.
Since 1999, the Bristol-Myers Squibb Foundation’s SECURE THE FUTURE® initiative has been working with partners in Africa to provide care and support for communities affected by HIV, tuberculosis, women’s cancer and most recently, lung cancer. Global HOPE will apply this same transformational model to pediatric oncology and hematology in a number of the same geographic areas.
Texas Children’s Cancer and Hematology Centers at Texas Children’s Hospital
Texas Children’s Cancer and Hematology Centers (TXCH) is the largest pediatric hematology-oncology program in the U.S., treating patients from 35 states and 26 countries. TXCH performs advanced patient care, cutting edge clinical and laboratory research and has largest training program for pediatric hematology-oncology in the U.S. With a staff of renowned experts, the centers have developed a wide array of programs aimed at curing children with diagnoses ranging from the most common to the very rare. The team of 186 faculty and nearly 1,000 staff have pioneered many of the now standard treatments for pediatric cancer and blood disorders. TXCH has a long-standing commitment to improving global health. For more information, please visit txch.org.
Baylor College of Medicine International Pediatric AIDS Initiative at Texas Children’s Hospital (BIPAI)
Baylor International Pediatric AIDS Initiative (BIPAI) is a non-profit organization dedicated to providing pediatric and maternal health care in resource limited settings. BIPAI medical teams offer free medical care and medical education for HIV/AIDS, tuberculosis, malaria, malnutrition, obstetrics/gynecology, hematology/oncology and more. Partnering with Texas Children’s Hospital and Baylor College of Medicine, BIPAI operates in 11 countries, caring for nearly 300,000 children and their families. Learn more at www.bipai.org

Curecanti National Recreation Area

From U.S. Department of the Interior:




Curecanti National Recreation Area in Colorado is a series of three reservoirs along the once wild Gunnison River. The reservoirs that make up Curecanti today are a destination for water-based recreation high in the Rocky Mountains. Best known for salmon and trout fishing, Curecanti also offers opportunities for hiking, boating, camping and bird watching. Start planning your trip now. Photo by Alex Stephens, Bureau of Reclamation. — at Curecanti National Recreation Area




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