Saturday, March 30, 2013
Friday, March 29, 2013
Thousands of Oklahoma Dental Patients Possibly Infected With HIV, Hepatitis - YouTube
Trusted dentist may have exposed patients to disease. Health officials urge patients to get tested.
Video (2:36)
Thousands of Oklahoma Dental Patients Possibly Infected With HIV, Hepatitis - YouTube
Video (2:36)
Thousands of Oklahoma Dental Patients Possibly Infected With HIV, Hepatitis - YouTube
Thursday, March 28, 2013
Wednesday, March 27, 2013
Tuesday, March 26, 2013
Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
News Release:
FOSTER CITY, Calif. --(BUSINESS WIRE)--Mar. 26, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today provided an update on ION-1, a Phase 3 clinical trial evaluating a once-daily fixed-dose combination of the nucleotide sofosbuvir and the NS5A inhibitor ledipasvir with and without ribavirin (RBV) for 12 or 24 weeks among treatment-naïve genotype 1 patients with hepatitis C virus (HCV) infection (n=800). A planned review by the study's Data and Safety Monitoring Board (DSMB) of safety data from 200 patients in all four arms and of SVR4 rates (sustained virologic response four weeks after completion of therapy) from 100 patients in the two 12-week duration arms concluded that the trial should continue without modification. This recommendation is based upon the observed SVR4 rates exceeding the predefined threshold of 60 percent and the absence of significant safety issues. Enrollment of the remaining 600 patients in ION-1 is now underway.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California , Gilead has operations in North America , Europe and Asia Pacific .
Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients
-- Enrollment in ION-1 Study Continues Following Planned DSMB Review --
Sofosbuvir/ledipasvir is also being evaluated in a second Phase 3 study, ION-2, initiated in January 2013 , which is now fully enrolled. ION-2 is evaluating sofosbuvir/ledipasvir with RBV for 12 weeks, and with and without RBV for 24 weeks, among 400 treatment-experienced genotype 1 HCV patients. Participants in this study failed to respond to past therapy containing pegylated interferon (peg-IFN) or peg-IFN plus a protease inhibitor.
Sofosbuvir, ledipasvir and the sofosbuvir/ledipasvir fixed-dose combination are investigational products and their safety and efficacy have not yet been established.
About Gilead Sciences
Source: Gilead Sciences, Inc.
European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Company's empagliflozin*, an investigational type 2 diabetes treatment (NYSE:LLY)
Not necessarily about infectious disease, but still of possible interest:
European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Company's empagliflozin*, an investigational type 2 diabetes treatment (NYSE:LLY)
European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Company's empagliflozin*, an investigational type 2 diabetes treatment (NYSE:LLY)
Pfizer Invites Public to View and Listen to Webcast of April 30 Conference Call with Analysts
Not necessarily about infectious disease, but still of possible interest:
Pfizer Invites Public to View and Listen to Webcast of April 30 Conference Call with Analysts
Tuesday, March 26, 2013 10:00 am EDT
Dateline:
NEW YORK
Public Company Information:
NYSE:
PFE
US7170811035
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, April 30, 2013. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2013 Performance Report, to be issued that morning.
To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com and click on the “Pfizer Quarterly Corporate Performance – First Quarter 2013” link in the Investor Presentations section located on the lower right-hand corner of that page. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com beginning today. Participants are advised to pre-register in advance of the conference call.
You can also listen to the conference call by dialing either (866) 246-2545 in the United States and Canada or (706) 634-2365 outside of the United States and Canada. The password is “First Quarter Earnings”.
Visitors to www.pfizer.com will be able to view and listen to an archived copy of the webcast of the conference call.
Marcados por los genes | El País Semanal | EL PAÍS
Not necessarily about infectious disease, but still of possible interest:
Marcados por los genes | El País Semanal | EL PAÍS
Marcados por los genes | El País Semanal | EL PAÍS
Monday, March 25, 2013
Aetna Foundation Funds Study of Black-White Disparities in Infant and Maternal Health
Not necessarily about infectious disease, but still of possible interest:
Aetna Foundation Funds Study of Black-White Disparities in Infant and Maternal Health
-- University of Pittsburgh Will Examine Influence of High Stress Neighborhoods on Mothers and Babies --
Monday, March 25, 2013 2:15 pm EDT
"African Americans are more likely than whites to live in neighborhoods with limited options to buy healthy foods, more access to alcohol outlets, and less access to other important health-related resources,"
PITTSBURGH--(BUSINESS WIRE)--In Pennsylvania’s Allegheny County, the statistics on infant mortality tell a disturbing story of racial health disparities. Here, African-American babies are three or even four times more likely to die in their first year of life than white infants. They also are more likely to be born with a low birth weight or born prematurely. Their mothers are more likely to be obese or not gain enough weight during their pregnancy, increasing their risk of preterm birth, the biggest cause of infant death.
To better understand the racial disparity in maternal and infant health, the Aetna Foundation has awarded a $100,000 grant to the University of Pittsburgh Graduate School of Public Health. Researchers will study the potential influence of living in stressful neighborhoods on the health of African-American mothers and their babies.
“African Americans are more likely than whites to live in neighborhoods with limited options to buy healthy foods, more access to alcohol outlets, and less access to other important health-related resources,” said Dara D. Mendez, Ph.D., M.P.H., who is leading the study at the University of Pittsburgh’s Graduate School of Public Health. “We want to understand the influence of these neighborhood factors on the higher obesity rates among black women and the higher rates of adverse birth outcomes for their offspring.”
The study will focus on Pittsburgh and other towns in Allegheny County. Researchers will map the locations of the county’s food and alcohol outlets and the neighborhoods’ racial makeup, income levels and other demographics. Researchers will then compare their food and alcohol outlet map to infant birth and death records from 2003 to 2010, which includes information about the mothers’ pre-pregnancy body mass index and weight gain during their pregnancies.
“Racial disparities in infant mortality and the obesity epidemic are two of the most critical public health issues we face today,” said Gillian Barclay, D.D.S., Dr.PH., the Aetna Foundation’s vice president of national grant making. “We know that a community’s built environment can play a role in both, but there’s so much we don’t know yet. We hope that by studying specific environmental factors, researchers at the University of Pittsburgh can shed light on how to change neighborhoods with high health risks into healthier communities.”
The study is expected to be completed in December, 2014.
About the Aetna Foundation
The Aetna Foundation, Inc. is the independent charitable and philanthropic arm of Aetna Inc. Since 1980, Aetna and the Aetna Foundation have contributed $412 million in grants and sponsorships, including $18 million in 2011. As a national health foundation, we promote wellness, health, and access to high-quality health care for everyone. This work is enhanced by the time and commitment of Aetna employees, who have volunteered more than 2.6 million hours since 2003. Aetna’s current giving is focused on addressing the rising rate of adult and childhood obesity in the U.S.; promoting racial and ethnic equity in health and health care; and advancing integrated health care. For more information, visit www.AetnaFoundation.org.
Aetna Foundation Gives $25,000 to Help Latino Families in the Bronx Live Healthier
Not necessarily about infectious disease, but still of possible interest:
Aetna Foundation Gives $25,000 to Help Latino Families in the Bronx Live Healthier
-- Funds support The Committee for Hispanic Children and Families program --
Monday, March 25, 2013 2:02 pm EDT
"Buying healthy food can be especially difficult. Full-service supermarkets are scarce. Many families have very limited incomes and are forced to choose cheap, non-nutritious food, resulting in both malnutrition and obesity. ‘Healthy Living’ shows another way. We appreciate Aetna Foundation’s support."
BRONX, N.Y.--(BUSINESS WIRE)--The Aetna Foundation has awarded a $25,000 grant to The Committee for Hispanic Children and Families, Inc. (CHCF) to help Latino families in the Bronx adopt healthy eating habits and exercise regularly. The funds support “Healthy Living,” the organization’s nutrition and fitness program for students and their families at P.S. 279 Captain Manuel Rivera, Jr., in the Fordham Heights neighborhood.
CHCF’s “Healthy Living” combines Latino culture with fun activities for the whole family, such as dancing, cooking classes and games. The free 10-week classes meet Saturdays at P.S./M.S. 279 at 2100 Walton Avenue.
Elba Montalvo, president and CEO of CHCF, says that “Healthy Living” aims to reverse high obesity rates and diet-related health problems among Latino families in the Bronx. Program participants, she notes, often suffer from diabetes, asthma or high blood pressure.
“Our participants work long hours, often at non-traditional times, which puts a strain on them and makes planning healthy meals and exercise a challenge,” said Montalvo. “Buying healthy food can be especially difficult. Full-service supermarkets are scarce. Many families have very limited incomes and are forced to choose cheap, non-nutritious food, resulting in both malnutrition and obesity. ‘Healthy Living’ shows another way. We appreciate Aetna Foundation’s support.”
Sharon Dalton, vice president of the Aetna Foundation and director of its regional grant making, said, “Our mission is to promote health and wellness, particularly in underserved communities. By bringing together families and incorporating Hispanic traditions, CHCF’s program is a great way to make healthy new habits stick.”
Since CHCF launched “Healthy Living” in 2004, more than 800 people have taken classes. The program’s culture-based approach uses Latino traditions and values, such as traditional foods, Spanish seasonings, promenading in the plaza, dancing and music. The program includes field trips to farmers’ markets, tips for grocery shopping on a budget, and cooking classes that recreate favorite traditional dishes with less fat or sugar. The program is run by bilingual, bicultural staff members.
“Healthy Living” has had a positive impact on the program’s graduates. A 2010 survey of people who had participated earlier that year found that 80 percent reported losing weight and 87 percent were eating more vegetables than before they took part in the program.
About the Aetna Foundation
The Aetna Foundation, Inc. is the independent charitable and philanthropic arm of Aetna Inc. Since 1980, Aetna and the Aetna Foundation have contributed $413 million in grants and sponsorships, including $19.2 million in 2011. As a national health foundation, we promote wellness, health, and access to high-quality health care for everyone. This work is enhanced by the time and commitment of Aetna employees, who have volunteered more than 2.6 million hours since 2003. Aetna’s current giving is focused on addressing the rising rate of adult and childhood obesity in the U.S.; promoting racial and ethnic equity in health and health care; and advancing integrated health care. For more information, visit www.AetnaFoundation.org.
About The Committee for Hispanic Children and Families, Inc.
Since 1982, The Committee for Hispanic Children and Families, Inc. (CHCF) has been dedicated to combining education and advocacy to expand opportunities for children and families, and strengthen the voice of the Latino community. Believing that the most effective way to support Latino families is by building upon their existing strengths and fostering self-sufficiency, CHCF provides a number of programs and services to the community through Youth Development programs and an Early Care & Education Institute. Our policy work, grounded in our direct services, amplifies the voice of our communities on the local, state, and national policy levels around issues of child welfare, early care, education, juvenile justice, and the well-being of Latino children. Through our programs and policy work, CHCF is creating a shared prosperity for all Americans. For more information, please call (212) 206-1090 or visit our web site at http://www.chcfinc.org.
Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
News Release:
Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
Issued: 25 March, 2013, London UK
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for its Pandemic Influenza A Virus Monovalent Adjuvanted candidate vaccine, referred to as Q-Pan H5N1.
The candidate vaccine is intended for active immunization for the prevention of disease in adults 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.
A Complete Response letter is issued by FDA when a Prescription Drug User Fee Act (PDUFA) action date nears and additional review time is needed prior to approval. In this case, the Complete Response letter was triggered due to an administrative matter that has recently been rectified. GSK and the FDA are actively working together to complete the review in a timely manner.
GSK’s Pandemic H5N1 influenza vaccine programme is supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services. In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine supports its licensure in adults.
About GSK VaccinesGlaxoSmithKline Vaccines is active in vaccine research and development. Headquartered in Belgium, GSK Vaccines has 13 manufacturing sites strategically positioned around the globe. Of the 883 million doses of our vaccines we distributed in 2012, over 80% went to developing countries, which include the least developed, low- and middle-income countries.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
American College of Endocrinology (ACE) to emphasize emergency planning for people with diabetes at National Hurricane Conference (NYSE:LLY)
Not necessarily about infectious disease, but still of possible interest:
American College of Endocrinology (ACE) to emphasize emergency planning for people with diabetes at National Hurricane Conference (NYSE:LLY)
American College of Endocrinology (ACE) to emphasize emergency planning for people with diabetes at National Hurricane Conference (NYSE:LLY)
Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment (NYSE:LLY)
Not necessarily about infectious disease, but still of possible interest:
Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment (NYSE:LLY)
Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment (NYSE:LLY)
Over 50? Of Course You’ve Still Got It, and the Y and Pfizer are Launching 50 MOVING FORWARD to Help You Keep It
Not necessarily a post about infectious disease, but still of possible interest:
Over 50? Of Course You’ve Still Got It, and the Y and Pfizer are Launching 50 MOVING FORWARD to Help You Keep It
50 MOVING FORWARD concentrates on health, prevention, fitness and fun to foster healthy aging among the Y’s fastest growing age group
Monday, March 25, 2013 8:05 am EDT
Dateline:
CHICAGO and NEW YORK
Public Company Information:
NYSE:
PFE
"People 50 years and older are the fastest growing age group of the Y, and 50 MOVING FORWARD’s action plan, focused on health, fitness, preventive measures and fun, takes into account their busy lives so they can celebrate milestones at their own pace,"
CHICAGO and NEW YORK--(BUSINESS WIRE)--Forget “50 is the new 40” or even “the new 30,” age 50 is about moving forward. That’s why YMCA of the USA (Y-USA) and Pfizer Inc launched 50 MOVING FORWARD, a healthy living plan designed to motivate adults 50 years and older with fresh ideas about behaviors that experts say are crucial to healthy aging: physical activity; preventive measures like screenings and vaccinations; healthy eating; and social interaction.
Those who want practical information, tips and activities that will help them build a healthier future can enroll online starting today through the next six months at YMCA.net/50MovingForward or in-person at a participating YMCA.
“People 50 years and older are the fastest growing age group of the Y, and 50 MOVING FORWARD’s action plan, focused on health, fitness, preventive measures and fun, takes into account their busy lives so they can celebrate milestones at their own pace,” says Jim Kauffman, national director for health and well-being for Y-USA. “Bringing 50 MOVING FORWARD to adults over 50 across the country represents a new way for the Y to connect with older adults as we continue our mission of creating an environment that promotes the health and well-being of the communities we serve.”
50 MOVING FORWARD: A Wide-Ranging Approach for a Growing, Aging Population
Adults 50 years and older currently make up more than 30 percent of the US population, and by 2015, are expected to represent 45 percent of Americans. The Centers for Disease Control and Prevention (CDC) suggests that adults 50 and older have a 70 percent chance of developing at least one chronic disease. That’s why the Y, one of the nation’s leading nonprofits dedicated to improving the nation’s health, teamed up with Pfizer, with its health care expertise, to develop 50 MOVING FORWARD. Together, they are working with older adults to help them address their health and well-being.
“It’s important for people to eat well and be active, and they should also talk with their health care provider about getting regular health screenings and keeping vaccinations current,” says Dr. Freda Lewis-Hall, chief medical officer at Pfizer. “Every year hundreds of thousands of American adults are hospitalized from diseases such as influenza, shingles and pneumococcus, that could have been prevented by vaccination. By offering education on prevention along with fun activities, 50 MOVING FORWARD can help adults to embrace a healthier lifestyle.”
50 MOVING FORWARD goes beyond the basic tenets of healthy eating and physical activity and highlights the importance of helping prevent health problems before they arise through screenings and vaccinations, as well as the health benefits of staying socially active and connected. One of the most beneficial things people can do is to take steps to prevent illness. Even those who already practice healthy habits should be aware of things that may affect their health because as people age, their immune systems naturally begin to weaken.
50 MOVING FORWARD: Journey to a Healthier Future
Whether those 50 years and older are just getting started or are already practicing healthy habits, 50 MOVING FORWARD will help adults overcome common barriers to making healthy lifestyle choices. Participants can enroll:
- online at YMCA.net/50MovingForward, where they can opt-in to receive e-mails providing information, tips, patient/health care provider discussion guides and activities that can be incorporated into their lives anywhere, anytime
- in person at a participating YMCA, where they can join in wellness events and classes designed for adults 50 years and older
50 MOVING FORWARD will be offered at 25 YMCA associations across the country, and both YMCA members and nonmembers are invited to join. To find a participating Y, visit YMCA.net/50MovingForward.
About the Y
The Y is one of the nation’s leading nonprofits strengthening communities through youth development, healthy living and social responsibility. Across the U.S., 2,700 Ys engage 21 million men, women and children – regardless of age, income or background – to nurture the potential of children and teens, improve the nation’s health and well-being, and provide opportunities to give back and support neighbors. Anchored in more than 10,000 communities, the Y has the long-standing relationships and physical presence not just to promise, but to deliver, lasting personal and social change. ymca.net
Pfizer and Healthy Aging
Pfizer works to encourage action for healthy aging through multiple programs. To learn more, please visit www.getold.com.
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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care 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. To learn more, please visit us at www.pfizer.com.
XELJANZ® (tofacitinib citrate) Approved in Japan for the Treatment of Adults with Rheumatoid Arthritis (RA)
Not necessarily a post about infectious disease, but still of possible interest:
XELJANZ® (tofacitinib citrate) Approved in Japan for the Treatment of Adults with Rheumatoid Arthritis (RA)
Monday, March 25, 2013 7:20 am EDT
Dateline:
NEW YORK
Public Company Information:
NYSE:
PFE
US7170811035
"We are proud of our strong portfolio of treatments for inflammatory disorders in Japan, and we are pleased with the approval of XELJANZ, which allows us to offer an additional treatment option for RA patients."
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved XELJANZ® (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. XELJANZ may be used in patients in whom clinical symptoms due to the disease remain even after appropriate treatment with at least one other disease-modifying antirheumatic drug (DMARD), such as methotrexate. The recommended dose of XELJANZ is 5 mg twice daily.
XELJANZ will be commercially available in Japan after the National Health Insurance listing and will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company Limited. Pfizer and Takeda also currently co-promote the RA drug Enbrel® (etanercept) in Japan.
XELJANZ (ZEL’ JANZ’) is the first approved oral treatment in a new class of medicines known as Janus kinase (JAK) inhibitors. Initially, XELJANZ will be made available in Japan to medical institutions participating in an all-patient surveillance program.
“RA is a serious and disabling disease and there is a need for new treatment options, as a significant number of patients do not adequately respond to current therapies,” said Mark Swindell, Head of Pfizer Specialty Care Business Unit in Japan. “We are proud of our strong portfolio of treatments for inflammatory disorders in Japan, and we are pleased with the approval of XELJANZ, which allows us to offer an additional treatment option for RA patients.”
Unlike biologic therapies that target RA outside the cell, XELJANZ targets the disease from inside the cell. It is specifically designed to inhibit the Janus kinase (JAK) pathways, which are signalling pathways inside the cell that play a role in the inflammation involved in RA.
The approval of XELJANZ in Japan is supported by a multi-study, global clinical development program, which evaluated XELJANZ in approximately 5,000 patients across various RA patient populations. The application also included data from Japanese subjects from two phase 2 studies, one phase 3 study and an ongoing long-term extension study. Across five global pivotal trials, XELJANZ 5 mg twice daily demonstrated efficacy, whether administered alone or in combination with a non-biologic DMARD, such as methotrexate, in patients who had a previous inadequate response to non-biologic or biologic DMARDs, including tumor necrosis factor (TNF) inhibitors.
XELJANZ is approved for the treatment of RA patients who have had an inadequate response to existing therapies. Notable safety findings observed in the XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 700,000 – 800,000 people in Japan1 and 23.7 million people worldwide.2 Although multiple treatments are available, many patients do not adequately respond. Specifically, up to one-third of patients do not adequately respond and about half stop responding to any particular DMARD within five years.3,4,5,6,7,8 There remains a need for additional options.
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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care 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. To learn more, please visit us at www.pfizer.com.
1 Report from Study Committee on Rheumatoid Arthritis and Allergy Accessed on 13 March 2013.http://www.mhlw.go.jp/stf/houdou/2r9852000001nfao-att/2r9852000001nfdx.pdf
2 World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available athttp://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
3 Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. The Lancet 2004. 363: 675-681
4 Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy.Arthritis & Rheumatism 2004. 50: 1400-1411
5 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the treatment of rheumatoid arthritis. The New England Journal of Medicine 2000. 1594-1602.
6 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. J Rheumatol 2006; 33:2433-8.
7 Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.
8 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther 2011;33(7):901-913.
Saturday, March 23, 2013
Friday, March 22, 2013
Baxter and Halozyme Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies
News Release:
Baxter and Halozyme Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies
LONDON, ENGLAND, March 22, 2013 - Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC.
"This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients."
The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year.
"Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients", said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.
"Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients", said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.
About HyQviaHyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two components are packaged together as a dual vial unit: IGSC provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IGSC, increasing the bioavailability. The IGSC is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.
HyQvia is indicated as replacement therapy in adults (>18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Important Safety InformationHyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.
About Immunodeficiency DisordersPrimary Immunodeficiencies (PI) are a group of more than 175 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are more likely to become infected and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary, or inherited, immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.
Secondary immunodeficiencies develop as a result of a variety of conditions such as malignancies, particularly those of the haematopoietic and lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore, burns or severe infection can also cause defective immune function and poor antibody response. In particular, immunoglobulin therapies are used to treat hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). These patients may benefit from immunoglobulin replacement therapy in addition to standard treatment of their primary disease.
About Baxter International Inc.Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
About Halozyme TherapeuticsHalozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma, Intrexon, and Pfizer. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
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Ahead of Print - Photo Quiz - Who is this man and what did he accomplish? - Vol. 19 No. 4 - April 2013 - Emerging Infectious Disease journal - CDC
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ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1
News Release:
ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1
Atlanta, Georgia, 6 March, 2013 - ViiV Healthcare today announced 24-week data from the Phase III SAILING (ING111762) study evaluating the investigational integrase inhibitor dolutegravir in patients with HIV-1 who are failing on current therapy, but had not been treated with an integrase inhibitor. At 24 weeks, 79% of study participants receiving the once-daily dolutegravir regimen were virologically suppressed (HIV-1 RNA <50 c/mL) vs. 70% of participants on the twice-daily raltegravir regimen. This difference in response was statistically significant with a 95% confidence interval for the difference of 3.4% to 15.9% (p=0.003). The SAILING study was designed to demonstrate non-inferiority of a regimen containing dolutegravir versus raltegravir (both with up to two background agents) and the analysis met this criterion; statistical superiority was concluded as part of a pre-specified testing procedure. These data were presented at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, Georgia.
Differences in treatment outcome in favour of the dolutegravir arm were driven by greater virologic response: at Week 24, 15% of patients receiving the dolutegravir regimen had virologic non-response vs. 24% of patients receiving the raltegravir regimen. In addition, fewer subjects failed therapy with integrase inhibitor resistance on dolutegravir (n=2) than on raltegravir (n=10, p=0.016).
Overall, the tolerability of dolutegravir (DTG) was similar to that of raltegravir (RAL). At 24 weeks, 2% of subjects on the dolutegravir regimen discontinued due to adverse events (AEs) vs. 4% of subjects on the raltegravir regimen. The rate of drug-related AEs was similar for both arms (DTG 20%, RAL 23%) and commonly reported AEs (defined as events that occurred in more than 10% of subjects) were similar on both arms, namely diarrhoea (20% DTG, 17% RAL) and upper respiratory tract infection (11% DTG, 8% RAL).
“People living with HIV who have developed resistance to more than one antiretroviral drug class face increasingly narrow treatment options and clinical decisions become increasingly complex. We welcome these initial results supporting the efficacy and tolerability of dolutegravir as a potentially useful addition in the management of HIV in treatment-experienced patients.” said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. “These encouraging data were included as part of the comprehensive clinical data package supporting recent regulatory submissions for dolutegravir and we look forward to receiving the primary analysis at 48 weeks in due course.”
About the SAILING studyThe primary objective of the ongoing double-blind, double-dummy phase III SAILING study is to demonstrate the antiviral activity of once-daily dolutegravir 50mg compared to twice-daily raltegravir 400mg over 48 weeks in HIV-1 infected, antiretroviral-experienced, integrase inhibitor-naïve adults. At baseline, 715 study participants were randomised 1:1 to receive either dolutegravir or raltegravir plus investigator-selected background regimen of no more than 2 agents, one of which was fully active. All subjects had documented genotypic or phenotypic resistance to agents from at least two antiretroviral therapy drug classes, and ongoing virologic replication. Median baseline HIV-1 RNA levels were 4.18 log10 c/mL and median baseline CD4+ cell counts were 200 cells/mm3. The study population included 32% women, 42% were of African American/African heritage, and 46% of study participants were classified as CDC Class C (patients who have one or more AIDS-defining illness). The 48-week primary analysis of this study will be presented at a future scientific meeting.
About Dolutegravir and the Dolutegravir Clinical Trial ProgrammeS/GSK1349572 (dolutegravir, DTG) is an investigational integrase inhibitor currently in development for the treatment of HIV; it does not require an additional pharmacokinetic boosting drug to be added to the regimen. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
SAILING is the fourth Phase III dolutegravir study reporting in 2012 and 2013. Data from the two studies in treatment-naïve populations, SPRING-2 (ING113086) and SINGLE (ING114467), were announced in April and July of 2012 respectively. Data from VIKING-3 (ING112574) in integrase inhibitor-resistant patients were announced in November 2012. Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.
About ViiV HealthcareViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a 10% shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.
ViiV UK/US Media enquiries:
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Camilla Bull
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+44 (0) 20 8380 6226
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Marc Meachem
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+1 919 483 8756
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GSK Global Media enquiries:
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David Daley
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+44 (0) 20 8047 5502
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Eleanor Bunch
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+44 (0) 20 8047 5502
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GSK Analyst/Investor enquiries:
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Sally Ferguson
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+44 (0) 20 8047 5543
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Lucy Budd
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+44 (0) 20 8047 2248
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Tom Curry
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+ 1 215 751 5419
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Gary Davies
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+ 44 (0) 20 8047 5503
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James Dodwell
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+ 44 (0) 20 8047 2406
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Jeff McLaughlin
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+ 1 215 751 7002
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Ziba Shamsi
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+ 44 (0) 20 8047 3289
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Shionogi forward-looking statement: This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kind.
GlaxoSmithKline cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.
Pfizer disclosure notice: Pfizer assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments. This release contains forward-looking information about Pfizer, GlaxoSmithKline and ViiV Healthcare and about the prospects of the companies, including revenues from in-line products and the potential benefits of product candidates that will be contributed to that company, as well as the potential financial impact of the transaction. Such information involves substantial risks and uncertainties including, among other things, decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments. A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report of Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.
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