Monday, April 29, 2013
Thursday, April 25, 2013
Bird Flu: Biggest Threat to Chinese Airlines
Siva Govindasamy, Asia Managing Editor of Flightglobal says domestic demand in China's airline sector is strong, but bird flu is the biggest threat that could derail growth.
Video (4:02)
Bird Flu: Biggest Threat to Chinese Airlines
Video (4:02)
Bird Flu: Biggest Threat to Chinese Airlines
Wednesday, April 24, 2013
Tuesday, April 23, 2013
Monday, April 22, 2013
Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II Clinical Trial Evaluating Combination of Investigational Oral Candidates MK-5172 and Daclatasvir for Chronic Hepatitis C
Merck News Release:
Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II Clinical Trial Evaluating Combination of Investigational Oral Candidates MK-5172 and Daclatasvir for Chronic Hepatitis C
Monday, April 22, 2013 7:30 am EDT
"In HCV, agreements like this that combine novel investigational candidates are important to evaluate the potential of novel oral regimens early in the development cycle,"
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
“In HCV, agreements like this that combine novel investigational candidates are important to evaluate the potential of novel oral regimens early in the development cycle,” said Eliav Barr M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. “We are pleased to collaborate with Bristol-Myers Squibb to advance this potential all-oral combination.”
The planned initiation of the Phase II clinical trial follows the completion of a Phase I safety evaluation of the investigational combination regimen. Under the agreement, Merck will conduct the Phase II clinical trial. Further clinical development activities beyond the Phase II study are not covered as part of this agreement. Additional details of the collaboration were not disclosed.
About MK-5172
MK-5172 is an investigational orally available HCV NS3/4A protease inhibitor currently being evaluated in combination with other approved and investigational medications in Phase II clinical trials. This includes an all oral combination with MK-8742, Merck’s investigational orally available HCV NS5A protease inhibitor.
Merck's Global Commitment to Development of Hepatitis Therapies
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional oral therapies for viral hepatitis treatment.
About Daclatasvir
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential direct-acting antiviral (DAA) based hepatitis C treatment regimens. Studied in more than 4,100 patients to date, daclatasvir is in Phase III development.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of 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,Facebook and YouTube.
Thursday, April 18, 2013
Wednesday, April 17, 2013
Lawmakers grill FDA chief on outbreak - The Hill's Healthwatch
House lawmakers went another round with the chief U.S. drug regulator Tuesday over a deadly meningitis outbreak and how federal authorities should oversee the type of pharmacy that produced it.
Food and Drug Administration (FDA) Commissioner Margaret Hamburg pleaded with lawmakers for more authority to regulate firms like the New England Compounding Center (NECC), which made the tainted steroid injections that have killed 53 and sickened more than 700 since last fall.
Read more: http://thehill.com/blogs/healthwatch/public-global-health/294359-lawmakers-grill-fda-chief-on-outbreak-#ixzz2QidqnfJ3
Follow us: @thehill on Twitter | TheHill on Facebook
Lawmakers grill FDA chief on outbreak - The Hill's Healthwatch
Tuesday, April 16, 2013
Monday, April 15, 2013
WHO | Human infection with influenza A(H7N9) virus in China - update
Dated April 14, Received April 15, 2013.
WHO | Human infection with influenza A(H7N9) virus in China - update
WHO | Human infection with influenza A(H7N9) virus in China - update
WHO | Human infection with influenza A(H7N9) virus in China - update
Dated April 13, Received April 15, 2013
WHO | Human infection with influenza A(H7N9) virus in China - update
WHO | Human infection with influenza A(H7N9) virus in China - update
Friday, April 12, 2013
Thursday, April 11, 2013
Sanofi CEO on Bird Flu Fears
Sanofi CEO Chris Viehbacher shares his opinion on how China has handled recent bird flu concerns and what impact President Obama's budget might have on pharmaceuticals.
Video (4:09)
Sanofi CEO on Bird Flu Fears
Video (4:09)
Sanofi CEO on Bird Flu Fears
Wednesday, April 10, 2013
Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole)
Merck News Release:
Merck Announces FDA Acceptance of New Drug Application for an Investigational Tablet Formulation of the Antifungal NOXAFIL® (posaconazole)
Wednesday, April 10, 2013 8:30 am EDT
"Invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients,"
WHITEHOUSE STATION N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that its New Drug Application for an investigational, tablet formulation of the company's antifungal agent, NOXAFIL®(posaconazole), has been accepted for review by the U.S. Food and Drug Administration (FDA).
Merck currently markets NOXAFIL Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic stem cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged low white blood cell counts (neutropenia) as a result of chemotherapy.
“Invasive fungal infections are a significant cause of illness and death among severely immunocompromised patients,” said Robin Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “This filing for a tablet formulation of NOXAFIL is an example of Merck’s ongoing commitment to developing new therapy options for patients in the hospital setting.”
Merck is seeking FDA approval of NOXAFIL tablets for once-daily administration (following a twice-a-day loading dose on the first day of therapy). The company has filed a marketing authorization application for NOXAFIL tablets with the European Medicines Agency (EMA) and plans to seek regulatory approval for the tablet formulation in other countries around the world.
Selected safety information about NOXAFIL (posaconazole) Oral Suspension
NOXAFIL is contraindicated in persons with known hypersensitivity to posaconazole, any component of NOXAFIL, or other azole antifungal agents.
NOXAFIL is contraindicated with sirolimus. Concomitant administration of NOXAFIL with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
NOXAFIL is contraindicated with the CYP3A4 substrates that prolong the QT interval. Concomitant administration of NOXAFIL with the CYP3A4 substrates pimozide and quinidine may result in increased plasma concentrations of these drugs, leading to QTc prolongation and rare occurrences of torsades de pointes.
NOXAFIL is contraindicated with HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 (e.g., atorvastatin, lovastatin, and simvastatin) as increased plasma concentration of these drugs can lead to rhabdomyolysis.
NOXAFIL is contraindicated with ergot alkaloids. NOXAFIL may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
Concomitant administration of NOXAFIL with cyclosporine or tacrolimus increases the whole blood trough concentrations of these calcineurin inhibitors. Nephrotoxicity and leukoencephalopathy (including isolated deaths) have been reported in clinical efficacy studies in patients with elevated cyclosporine concentrations. Frequent monitoring of cyclosporine or tacrolimus whole blood trough concentrations should be performed during and at discontinuation of NOXAFIL treatment and the tacrolimus or cyclosporine dose adjusted accordingly.
Some azoles, including NOXAFIL, have been associated with prolongation of the QT interval on the electrocardiogram. In addition, rare cases of torsades de pointes have been reported in patients taking NOXAFIL. NOXAFIL should be administered with caution to patients with potentially proarrhythmic conditions. Rigorous attempts to correct potassium, magnesium, and calcium should be made in these patients before starting NOXAFIL.
Hepatic reactions (e.g., mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis) have been reported in clinical trials. The elevations in liver function tests were generally reversible on discontinuation of therapy, and in some instances these tests normalized without drug interruption and rarely required drug discontinuation. Isolated cases of more severe hepatic reactions including cholestasis or hepatic failure including deaths have been reported in patients with serious underlying medical conditions (e.g., hematologic malignancy) during treatment with NOXAFIL (posaconazole). Liver function tests should be evaluated at the start of and during the course of therapy. Discontinuation of NOXAFIL must be considered if clinical signs and symptoms consistent with liver disease develop that may be attributable to NOXAFIL.
Concomitant administration of NOXAFIL with midazolam increases the midazolam plasma concentrations by approximately 5-fold. Increased plasma midazolam concentrations could potentiate and prolong hypnotic and sedative effects. Patients must be monitored closely for adverse effects associated with high plasma concentrations of midazolam and benzodiazepine receptor antagonists must be available to reverse these effects.
NOXAFIL has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious. NOXAFIL is also a strong inhibitor of CYP3A4. Therefore, plasma concentrations of drugs predominantly metabolized by CYP3A4 may be increased by NOXAFIL. The product label should be consulted when other drugs are prescribed with NOXAFIL.
Co-administration of NOXAFIL with rifabutin, phenytoin, efavirenz, cimetidine and esomeprazole should be avoided unless the benefit outweighs the risk. Monitoring for toxicity and adverse events is recommended when tacrolimus, cyclosporine, ritonavir, atazanavir, vinca alkaloids, and calcium channel blockers and rifabutin are co-administered with NOXAFIL. Dosage adjustments should also be considered when tacrolimus, cyclosporine, vinca alkaloids, calcium channel blockers, and phenytoin are administered with NOXAFIL. Monitor plasma concentrations when co-administering digoxin, phenytoin, tacrolimus and cyclosporine with NOXAFIL. Monitor for breakthrough fungal infections when co-administering metoclopramide, fosamprenavir, rifabutin, phenytoin, cimetidine and esomeprazole with NOXAFIL.
The safety and effectiveness of NOXAFIL in patients below the age of 13 years old have not been established.
The most common adverse reactions (>30%) in the prophylaxis clinical studies were fever, diarrhea, and nausea.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of 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, Facebook and YouTube.
Tuesday, April 9, 2013
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
Gilead News Release:
FOSTER CITY, Calif. --(BUSINESS WIRE)--Apr. 8, 2013-- Gilead Sciences (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA ) for approval of sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection. The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
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 Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1 Patients --
Chronic HCV infection affects up to four million Americans, particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States . Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN, which has to be injected and is associated with significant side effects, leaving some patients unable to complete therapy. If approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and depending on the genotype, would either eliminate or reduce the duration of peg-IFN injections.
“Current therapies are not suitable for large numbers of patients with HCV infection, and are challenging to take and tolerate,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences . “Sofosbuvir’s antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease.”
The sofosbuvir NDA is supported primarily by data from four phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV.
Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union , in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission .
About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein, which plays an essential role in HCV replication. Unlike ribavirin and pegylated interferon, sofosbuvir is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Sofosbuvir is intended to become a cornerstone of interferon-free, all-oral treatment regimens for HCV that achieve higher cure rates more rapidly and with fewer side effects than current therapeutic options. Sofosbuvir is an investigational product and its safety and efficacy has not yet been established.
About Gilead Sciences
Monday, April 8, 2013
Hepatitis scare at upscale NYC restaurant - YouTube
An upscale restaurant in the West Village of New York City, called Alta, received an alarming call from one of its employees, who contracted Hepatitis A during a trip to Mexico.
Video (1:33)
Hepatitis scare at upscale NYC restaurant - YouTube
Video (1:33)
Hepatitis scare at upscale NYC restaurant - YouTube
Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting
Merck News Release:
Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting
Monday, April 8, 2013 10:37 am EDT
"We are pleased to present new data on VICTRELIS that will help inform health care professionals as they consider the use of VICTRELIS in appropriate patients,"
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that two analyses of VICTRELIS (boceprevir) and data from Phase II studies of two of Merck’s investigational medicines for chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir (MK-7009), will be presented at the 2013 International Liver Congress (EASL) Annual Meeting. The meeting will take place in Amsterdam from April 24-28, 2013.
Key Presentations About VICTRELIS 200 mg Capsules
- Safety And Efficacy Of Boceprevir/Peginterferon/Ribavirin (Boc/P/R) Combination Therapy For Chronic HCV G1 Patients With Compensated Cirrhosis: A Meta-Analysis Of Five Phase III Clinical Trials, J.M. Vierling et al. Late Breaker. Thursday, April 25, 9:00- 18:00. RAI Convention Centre.
- Virologic Response Rates Are Similar In Previously Untreated And Previously Treated And Relapsed Patients Receiving Boceprevir Triple Therapy: A Retrospective Analysis. Bacon, B. et al. Poster 791. Friday, April 26, 12:30-14:00. RAI Convention Centre.
Key Investigational Compound Presentations
- High Sustained Viral Response at 12- and 24-week follow-up of MK-5172 with Pegylated Interferon alfa-2b and Ribavirin (PR) in HCV Genotype 1 Treatment-naïve Non-cirrhotic Patients. Manns, M. et al. Oral Presentation: Friday, April 26, 16:00-18:00, RAI Convention Centre.
- MK-5172 In Combination With Peg-Interferon And Ribavirin Elicits Limited Resistance While Demonstrating Robust Efficacy In Treatment Naïve Genotype 1 Chronic HCV-Infected Patients. Howe, A. et al. Poster 1197. Saturday, April 27, 12:30-13:30. RAI Convention Centre.
- Sustained Viral Response And Safety Of MK-7009 In Cirrhotic Treatment-Experienced Patients With Genotype 1 HCV Infection Who Have Failed Previous Pegylated Interferon And Ribavirin Treatment. Rodriguez-Torres, M. et al. Oral Presentation. Saturday, April 27, 8:30-10:30. RAI Convention Centre.
"We are pleased to present new data on VICTRELIS that will help inform health care professionals as they consider the use of VICTRELIS in appropriate patients," said Eliav Barr, M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. "Merck is committed to helping reduce the burden of this serious disease worldwide. We look forward to sharing our new data about VICTRELIS and Merck's investigational medicines for chronic hepatitis C with the global scientific community."
MK-5172 is an investigational, once-daily, oral HCV NS3/4A protease inhibitor currently in Phase II development. Vaniprevir is an oral, twice-daily HCV NS3/4A protease inhibitor in Phase III development in Japan for the treatment of genotype 1 patients.
The abstracts were published today and can be accessed on the EASL website. For program information, please visit http://www2.kenes.com/liver-congress/pages/home.aspx.
Indications and usage for VICTRELIS
VICTRELIS® (boceprevir) is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
- VICTRELIS must not be used as monotherapy and should only be used in combination with PR.
- The efficacy of VICTRELIS has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
- Poorly interferon responsive patients who were treated with VICTRELIS in combination with PR have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to PR.
Important safety information about VICTRELIS
All contraindications to PR also apply since VICTRELIS must be administered with PR. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with PR is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use 2 or more forms of effective contraception during treatment and for at least 6 months after treatment has concluded. One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated.
VICTRELIS is contraindicated in patients with a history of a hypersensitivity reaction to VICTRELIS. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS is also contraindicated in coadministration with potent CYP3A4/5 inducers, where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John’s Wort (hypericum perforatum), lovastatin, simvastatin, drospirenone, Revatio® (sildenafil) or Adcirca®(tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and/or Neutropenia – The addition of VICTRELIS to PR is associated with an additional decrease in hemoglobin concentrations compared with PR alone and/or may result in worsening of neutropenia associated with PR therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. If peginterferon alfa or ribavirin is permanently discontinued, VICTRELIS must also be discontinued. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of PR.
Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at Treatment Weeks 2, 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate. Serious acute hypersensitivity reactions (eg, urticaria, angioedema) have been observed during combination therapy with VICTRELIS and PR. If such an acute reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted.
The most commonly reported adverse reactions (>35%) in clinical trials in adult patients receiving the combination of VICTRELIS with PR were: fatigue, anemia, nausea, headache, and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates ≥5% above the rates for PR alone in either clinical study. The incidence of these adverse reactions in previously untreated subjects that were treated with combination therapy with VICTRELIS compared with PR alone were: fatigue (58% vs 59%), anemia (50% vs 30%), nausea (46% vs 42%), and dysgeusia (35% vs 16%), respectively. The incidence of these adverse reactions in previous treatment failure patients that were treated with combination therapy with VICTRELIS compared with PR alone were: fatigue (55% vs 50%), anemia (45% vs 20%), nausea (43% vs 38%), and dysgeusia (44% vs 11%), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at:http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
Merck's Global Commitment to Advancing Hepatitis Therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
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, Facebook and YouTube.
Saturday, April 6, 2013
Wednesday, April 3, 2013
Suspicious powder incidents require the right tools for quick action
Suspicious powder incidents require the right tools for quick action
April 03, 2013 
- PNNL Media Contacts, (509) 375-3776
DHS makes it easier to buy the right technology for bio-threat incidents
-
Representatives from Washington State firefighters, HazMat teams, Public Health Laboratories, Navy Region Northwest, Joint Base Lewis McChord, 10th Civil Support Team, Federal Bureau of Investigation, the private sector (Boeing), and the U.S. Department of Homeland Security assembled in 2012 to provide information on biodetection information need, gaps and priorities.
RICHLAND, Wash. – First responders know that white powder scenarios — or suspected biological threats — require quick and decisive action. Having the right field-deployable equipment available to determine what the suspicious substance is can be complicated, challenging and expensive.
Recently, the Department of Homeland Security's Science and Technology Directorate and Department of Energy's Pacific Northwest National Laboratory issued an informative report that summarizes an extensive list of commercially available, hand-portable biodetection technologies. The report — Biodetection Technologies for First Responders — helps end-users such as firefighters, police officers and HazMat workers make informed decisions about procuring the right technology for their particular need and circumstance.
"The report serves as a product buying guide for end-users as well as procurement specialists," says Cindy Bruckner-Lea, PNNL project manager. "It provides specifics and details on dozens of commercially available technologies. This free report will be an important and useful resource for first response teams everywhere."
The release of the report is one part of a larger effort at PNNL to create partnerships with first responders that provide value to all parties. Early on in the process, PNNL conducted dozens of interviews and surveys, and held a workshop at Seattle's Joint Training Facility to better understand first responder biodetection and information needs, gaps and priorities. The exchanges helped researchers have a better grasp of the context by which first responders perform their duties. This leads to better results and the ability to get the best solution faster and more efficiently.
PNNL is also conducting biodetection assay and instrument performance tests for both anthrax and ricin bio-threats and is investigating the impact of commonly encountered "hoax" white powders. PNNL plans to facilitate performance and ergonomic testing of the most promising technology by first responders.
PNNL is also working with other agencies to help refine detection system performance requirements, standardized test plans and conditions, create guidelines for use and limitations of biodetection technology, and establish training and proficiency testing procedures.
According to law enforcement statistics, HazMat teams across the country respond to hundreds of white powder calls each year in large cities where quick decision-making is critical.
"Rapid biodetection is extremely important to the first responder community. In white powder response incidents where the health and safety of individuals may be in jeopardy, accurate and reliable results are needed promptly," says Seattle Fire Department, Assistant Chief, A.D. Vickery.
The information listed in the report is primarily provided by the vendor. However, when possible the report has been supplemented with additional information obtained from peer-reviewed publications, reports and websites that evaluate the performance of the technologies. Other findings and results will be published as the information becomes available.
PNNL has significant expertise in studying the biodetection process and in evaluating biodetection assays. It also has established an ongoing relationship with first responders in the Pacific Northwest. In coming months, PNNL will conduct third-party testing of biodetection assay systems and instruments. Researchers will publish a report outlining performance testing in working with anthrax, ricin and commonly encountered white powders.
PNNL will attend the International Hazardous Materials Response Teams Conference on June 6-9 in Baltimore, MD, and will be available to discuss the report and the next phase of testing that is just getting underway.
GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK
GSK News Release:
GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK
Issued: Wednesday 3 April 2013, London UK
GlaxoSmithKline plc announced today the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain influenza vaccine to be approved in a European country for active immunisation of adults and children from three years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. The new four-strain vaccine will be marketed as INFLUSPLIT™ TETRA* in Germany and FLUARIX™ TETRA▼ in the UK.
Human influenza virus strains A and B are responsible for causing seasonal flu epidemics globally. Current inactivated influenza vaccines in Europe are designed to provide protection against three strains of influenza virus (referred to as trivalent vaccines). They are composed of two influenza A strains (A/H1N1 and A/H3N2) and one B strain lineage, as recommended by the World Health Organization and its partners as the predominant strains in circulation for a given flu season. Currently there are 4 major strains of Influenza circulating, two influenza A strains (A/H1N1 and A/H3N2) and two B strain lineage (B-Victoria and B-Yamagata). As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine (referred to as vaccine ‘mismatch’).
INFLUSPLIT™ TETRA/FLUARIX™ TETRA have been developed to provide broader influenza strain coverage by the addition of a second B strain; thereby providing coverage against two influenza A strains and two influenza B strains. The vaccine is expected to help protect against four of the predominant strains of influenza circulating, thus potentially reducing the overall influenza related burden of disease.
INFLUSPLIT™ TETRA/FLUARIX™ TETRA is expected to be available for use in Germany and the UK in time for the 2013/2014 flu season. This vaccine was approved by the US Food and Drug Administration (FDA) in December 2012 (as FLUARIX™QUADRIVALENT). GSK has also submitted licence applications for this vaccine in Australia, Switzerland and Taiwan. Regulatory decisions for these countries are expected over the coming months.
About Seasonal Influenza
- Influenza is an acute viral infection that spreads easily from person to person, causing serious illness and death and is a serious public health issue. The most common symptoms of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing, and weakness/fatigue1.
- Yearly outbreaks of influenza affect all age groups, but the highest risk of complications occurs in children younger than two years of age, the elderly (65 years and older) and those with particular medical conditions (e.g., chronic lung, liver, heart, kidney, blood or metabolic diseases)1.
- The World Health Organization (WHO) estimates that annual epidemics can be responsible for three to five million cases of severe illness and up to 500,000 deaths per year worldwide1.
Further information about seasonal influenza can be found at:http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/influenza
About INFLUSPLIT™ TETRA/FLUARIX™ TETRA
INFLUSPLIT™ TETRA/FLUARIX™ TETRA is indicated for active immunization ofadults and children from 3 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
- INFLUSPLIT™ TETRA/FLUARIX™ TETRA is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
- Hypersensitivity to the active substances, to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate is a contraindication.
- Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
- In two clinical studies, healthy adults 18 years of age and older and healthy children 3 to 17 years of age were administered INFLUSPLIT™ TETRA/FLUARIX™ TETRA (more than 3,000 adults and 900 children) or GlaxoSmithKline’s trivalent influenza vaccine, FLUARIX™ (more than 1,000 adults and 900 children). Similar rates of solicited adverse events were observed in recipients of INFLUSPLIT TETRA™/FLUARIX™ TETRA and FLUARIX™. In all age groups the most frequently reported local adverse reaction after vaccination was injection site pain (36.4% to 40.9%). Very common adverse reactions (≥1/10) include irritability (reported as a solicited symptom in subjects less than 6 years of age), myalgia, injection site pain, and fatigue.
- Post-marketing data: There has been no post-marketing exposure to INFLUSPLIT™TETRA/FLUARIX™ TETRA. However, as all three of the influenza strains contained in FLUARIX™ are included in INFLUSPLIT™ TETRA/FLUARIX™ TETRA, the following adverse events that have been observed for FLUARIX™ during post-marketing surveillance may occur in patients receiving INFLUSPLIT™ TETRA post-approval. All of these adverse events are classified as rare (≥1/10,000 to <1/1,000).
- Blood and lymphatic system disorders: transient lymphadenopathy
- Immune system disorders: allergic reactions (including anaphylactic reactions)
- Nervous system disorders: neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome*
*Spontaneous reports of Guillain-Barré syndrome have been received following vaccination with FLUARIX™; however, a causal association between vaccination and Guillain-Barré syndrome has not been established.
- Skin and subcutaneous tissue disorders: urticaria, pruritus, erythema, angioedoema
- General disorders and administration site conditions: influenza-like illness, malaise
Overdosage is unlikely to have any untoward effect.
Detailed information on the use of INFLUSPLIT™ TETRA/FLUARIX™ TETRA and its safety profile are described in the Summary of Product Characteristics, which is expected to be published on the PEI website (www.pei.de/influenza vaccines) and on the Electronic Medicines Compendium (www.medicines.org.uk/emc/).
About GlaxoSmithKline Vaccines
GlaxoSmithKline 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
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