Wednesday, November 27, 2013
Tuesday, November 26, 2013
Monday, November 25, 2013
Mondo Guerra and the Merck HIV Educational Campaign I Design Invite the Community to Pledge Action in Honor of World AIDS Day
Merck News Release:
Mondo Guerra and the Merck HIV Educational Campaign I Design Invite the Community to Pledge Action in Honor of World AIDS Day
Every Pledge on ProjectIDesign.com Will Reveal a Piece of a New, Community-Created Design
Category:
Monday, November 25, 2013 1:31 pm EST
Public Company Information:
NYSE:
MRK
"This year’s World AIDS Day creation, as part of the I Design campaign, is particularly special because the community has physically contributed to this piece and is going to unveil it one pledge at a time"
To commemorate World AIDS Day 2013, Merck (NYSE: MRK), known as MSD outside the United States and Canada, is encouraging people impacted by HIV to take action with the educational HIV campaign, I Design. Starting today, visitors to www.ProjectIDesign.com can mark the day by making a pledge to learn more about HIV, educate someone else about the condition, or help themselves or a loved one manage their HIV care.
Each pledge will virtually reveal a portion of a specially-designed fashion item from I Design campaign spokesperson, fashion designer and Project Runway All Stars Season 1 winner Mondo Guerra. The community pledges will culminate in the unveiling of an exclusive fashion item on World AIDS Day, Sunday, December 1, 2013. This endeavor is in line with the goal of World AIDS Day: bring together people from around the world, raise awareness about HIV/AIDS and demonstrate international solidarity.
The one-of-a-kind fashion item is crafted from printed canvases created by the HIV Community during this year’s United States Conference on AIDS (USCA 2013). It symbolizes the uniqueness of each person living with HIV. Individuality is a focus of the I Design campaign, which encourages people to talk with their doctors to “tailor” their HIV treatment plan.
“This year’s World AIDS Day creation, as part of the I Design campaign, is particularly special because the community has physically contributed to this piece and is going to unveil it one pledge at a time,” said Mondo Guerra. “I was inspired by the many touching stories that people living with HIV shared with me through the campaign over the course of this year. This piece reflects how we came together in support of this important cause.”
As a fashion designer, Mondo has a history of using his artistic skills as an advocate to raise HIV awareness. This includes his “positivity print” from Project Runway Season 8 and the I Design“individuality scarf”—a scarf that can be uniquely styled and worn in different ways by all people—that debuted at this year’s USCA.
Join the I Design campaign and make a pledge on this World AIDS Day atwww.ProjectIDesign.com.
About I Design
I Design is a national HIV education campaign led by Merck, notable fashion designer Mondo Guerra and award-winning photographer Duane Cramer aimed at helping to empower people living with HIV to have open and meaningful discussions with their doctors about their treatment plan based on their medical and lifestyle needs.
To learn more about the campaign, visit www.ProjectIDesign.com where you can download aconversation checklist, which offers tips on how to engage in an open and honest dialogue with your doctor; design a digital textile illustrating your approach to managing HIV; and view videos and photos. To help you track and manage your health, there are the “My Health Matters” and “My Positive Agenda” mobile and desktop apps. These easy-to-use tools help you track the symptoms of your HIV, set up reminders to take your medications on time and keep a record of when you have taken them, which can serve to prompt you on important discussion points when you are with your doctor. For additional tips and to follow Merck, Mondo and Duane’s collaboration on I Design, join them on Twitter @Merck, @LoveMondoTrasho and @DuaneCramer.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebookand YouTube.
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H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure
GSK News Release:
H5N1 vaccine approved by the U.S. FDA as pandemic influenza preparedness measure
25 November 2013
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved its pandemic Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (also referred to as Q-Pan H5N1 influenza vaccine) for the immunisation of adults 18 and older for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. GSK received notification of the FDA approval late Friday afternoon (22 November).
The Q-Pan H5N1 influenza vaccine is composed of monovalent, inactivated, split A/H5N1 influenza virus antigen and GSK’s AS03 adjuvant. In clinical studies, the adjuvanted formulation stimulated the required immune response while using a smaller amount of antigen as compared to a formulation without adjuvant. This could translate to a greater number of doses available at the time of a pandemic.
“Supporting the U.S. Government’s capability to help protect Americans against pandemics ranks among GSK’s most important U.S. public-health responsibilities,” said Bruce Innis, Vice President of Vaccines Development for GSK. “H5N1-related illness has thus far been rare, but life-threatening when it has occurred. GSK scientists approached this clinical development project driven by the recognition that the resulting vaccine might be needed in the future to help protect millions of Americans against pandemic flu illness.”
GSK will make this vaccine available in the U.S. only if directed to by the Biomedical Advanced Development and Research Authority (BARDA) in the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The GSK H5N1 pandemic influenza vaccine programme has been supported by a development contract (HHSO100200700029C) from BARDA.
Licensure of the Q-pan H5N1 influenza vaccine is supported by data generated in two pivotal clinical studies showing that the vaccine was immunogenic and generally well-tolerated. The efficacy of GSK’s seasonal influenza vaccine FluLaval® Quadrivalent in the prevention of influenza disease was also submitted as supportive information.
In clinical trials, the most common solicited local reactions and general adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating. Full U.S. Prescribing Information will be available soon at us.gsk.com.
GSK’s Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, has also received marketing authorisation in Europe and Canada under the brand names, Pumarix™ and Arepanrix™ H5N1, respectively.
More about the H5N1 influenza strain
Influenza caused by the H5N1 strain has thus far been rare. The U.S. Centers for Disease Control (CDC) has reported that more than 600 human H5N1 cases have been reported to WHO from 15 countries in Asia, Africa, the Pacific, Europe and the Near East since November 2003. Approximately 60 percent of individuals with documented H5N1 disease have died. Access more CDC information on H5N1 at:http://www.cdc.gov/flu/avianflu/h5n1-people.htm.
GSK – 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
Friday, November 22, 2013
Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV
GSK News Release:
Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV
London, UK, 21 November 2013
ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Tivicay® (dolutegravir) for use in combination with other antiretroviral medicinal products for the treatment of HIV-infected adults and adolescents above 12 years of age.
“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “We are committed to research that seeks to make advances in treatment options for people living with HIV. To make progress, thousands of patients have supported us through their participation in clinical development work and we recognise their commitment today with great gratitude.”
The CHMP opinion is based on safety and efficacy data for dolutegravir from four pivotal Phase III studies1-4. These involved people living with HIV who were new to treatment and also those with prior experience of treatment, and included comparators representing antiretroviral treatments commonly used today in the battle against HIV. More than 2,500 people were treated across these studies, and the regulatory submission also included data in children aged 12 years and older.
A CHMP positive opinion is one of the final steps in the regulatory process leading to the marketing authorisation decision of the European Commission, which is expected early in 2014.
About Tivicay® (dolutegravir)
Tivicay® was approved by the U.S. FDA in August 2013 and by Health Canada in October 2013 – please refer to local labelling for more information. It is a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor. 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.
Regulatory applications are being evaluated in other countries worldwide. Regulatory applications for ViiV Healthcare’s developmental single-tablet regimen (STR) combining Tivicay with Kivexa®/Epzicom® (abacavir/lamivudine) were submitted to regulatory authorities in Europe, Canada and the U.S. in October 2013.
Important Safety Information for Tivicay® (dolutegravir) 50 mg Tablets:
Dolutegravir is not approved for any indication in the European Union. The following information is based on the Highlights section of the U.S. Prescribing Information for Tivicay. Please refer to the full Prescribing Information for more details.
Indication and Usage: Tivicay is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg.
The following should be considered prior to initiating treatment with Tivicay: poor virologic response was observed in subjects treated with Tivicay 50 mg twice daily with an integrase strand transfer inhibitor (INSTI)-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.
Contraindication: Co-administration of TIVICAY with dofetilide (anti-arrhythmic) is contraindicated due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events.
Hypersensitivity Reactions: Hypersensitivity reactions have been reported and were characterised by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. The events were reported in 1% or fewer subjects receiving TIVICAY in Phase 3 clinical trials. Immediately discontinue TIVICAY and other suspect agents if signs or symptoms of hypersensitivity reaction develop, (including but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, oral blisters or lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing.) Monitor clinical status, including liver aminotransferases, and initiate appropriate therapy. Delay in stopping treatment with TIVICAY or other suspect agents after the onset of hypersensitivity may result in a life-threatening reaction. TIVICAY should not be used in patients who have experienced a hypersensitivity reaction to TIVICAY.
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Coinfection: Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of TIVICAY. In some cases the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with TIVICAY are recommended in patients with underlying hepatic disease such as hepatitis B or C.
Fat Redistribution: Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.
Immune Reconstitution Syndrome: During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment. Autoimmune disorders have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of treatment.
Adverse Reactions: The most commonly reported (≥2%) adverse reactions of moderate to severe intensity in treatment naïve adult subjects in any one trial receiving TIVICAY in a combination regimen were insomnia (3%) and headache (2%).
Drug Interactions: Co-administration of TIVICAY with drugs that are strong inducers of UGT1A1 and/or CYP3A4 may result in reduced plasma concentrations of dolutegravir and require dose adjustments of TIVICAY.
- TIVICAY should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral iron supplements, oral calcium supplements, or buffered medications.
- Consult the full Prescribing Information for TIVICAY for more information on potentially significant drug interactions, including clinical comments.
Pregnancy: Pregnancy category B. TIVICAY should be used during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
Breastfeeding: Breastfeeding is NOT recommended due to the potential for HIV transmission and the potential for adverse reactions in nursing infants.
Paediatric Patients: Safety and efficacy of TIVICAY has not been established in children younger than 12 years old, or weighing <40 kg, or in INSTI-experienced paediatric patients with documented or clinically suspected INSTI resistance.
References
1 SINGLE (Study ING114467). A Trial Comparing GSK1349572 (dolutegravir) 50mg Plus Abacavir/Lamivudine Once Daily to Atripla. National Institutes of Health Study Identifier NCT01263015.
More information available at: http://www.clinicaltrials.gov/show/NCT01263015
2 SPRING-2 (Study ING113086). A Trial Comparing GSK1349572 (dolutegravir) 50mg Once Daily to Raltegravir 400mg Twice Daily. National Institutes of Health Study Identifier NCT01227824.
More information available at: http://clinicaltrials.gov/show/NCT01227824
3 VIKING-3 (Study ING112574). A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. National Institutes of Health Study Identifier NCT01328041.
More information available at: http://clinicaltrials.gov/show/NCT01328041
4 SAILING (Study ING111762). A Study of GSK1349572 (dolutegravir) Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults. National Institutes of Health Study Identifier NCT01231516.
More information available at: http://clinicaltrials.gov/show/NCT01231516
About ViiV Healthcare
ViiV 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.
Thursday, November 21, 2013
World Health Organization Slows Campaign against Polio in Syria - SPIEGEL ONLINE
Polio is making a comeback in a decimated part of Syria, but the delicate politics of the war are making vaccination campaigns difficult. As an epidemic looms over the region, anger over the World Health Organization's inaction is growing.
World Health Organization Slows Campaign against Polio in Syria - SPIEGEL ONLINE
World Health Organization Slows Campaign against Polio in Syria - SPIEGEL ONLINE
Wednesday, November 20, 2013
Thursday, November 14, 2013
Wednesday, November 13, 2013
Danish Pig Farmers Reduce Antibiotics to Prevent Drug Resistance - SPIEGEL ONLINE
Many tons of antibiotics are administered every year to chickens and pigs in Europe, a trend that encourages the rise of drug-resistant microbes. But Denmark has shown how farmers can be made to abandon this policy of dangerous over-medication.
Danish Pig Farmers Reduce Antibiotics to Prevent Drug Resistance - SPIEGEL ONLINE
Danish Pig Farmers Reduce Antibiotics to Prevent Drug Resistance - SPIEGEL ONLINE
Sunday, November 3, 2013
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