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Monday, July 27, 2015
XenoPort to Release Second Quarter Financial Results on August 5, 2015
SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. Naprosyn (Naproxen) without Rx (Nasdaq:XNPT) announced today that it will release its
second quarter financial results on August 5, 2015 at approximately 4:30
p.m. Buy Lamictal (Lamotrigine) without prescription Eastern Time. Evista (Raloxifene) without Rx The company will host a conference call at 5:00 p.m. About Donecept with no Rx
Eastern Time that same day to provide a summary of its financial results
and general business updates. Buy Tenormin (Atenolol) A replay of the call will be available for
one week following the event.
To access the conference call via the Internet, go to .XenoPort.com. Buy Vitamin K online
Please join the call at least 15 minutes prior to the start to ensure
time for any software downloads that may be required.
To access the live conference call via phone, dial 1-888-275-3514. http://futurepharmaceuticals.wordpress.com
International callers may access the live call by dialing 706-679-1417.
The reference number to enter the call is 82478839.
The replay of the conference call may be accessed that same day after
8:00 p.m. Eastern Time, via the Internet, at .XenoPort.com,
or via phone at 1-855-859-2056 for domestic callers, or 404-537-3406 for
international callers. The reference number to enter the replay of the
call is 82478839.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and
commercializing a portfolio of internally discovered product candidates
for the potential treatment of neurological disorders. XenoPort is
currently commercializing HORIZANT® (gabapentin enacarbil)
Extended-Release Tablets in the United States and developing its novel
fumaric acid ester product candidate, XP23829, as a potential treatment
for patients with moderate-to-severe chronic plaque-type psoriasis and
potentially for relapsing forms of multiple sclerosis. REGNITE®
(gabapentin enacarbil) Extended-Release Tablets is being marketed in
Japan by Astellas Pharma Inc. XenoPort has entered into a collaboration
with the National Institute on Alcohol Abuse and Alcoholism for the
potential development of HORIZANT as a treatment for AUD and has granted
exclusive world-wide rights for the development and commercialization of
its clinical-stage oral product candidate, arbaclofen placarbil, to
Indivior PLC for all indications. XenoPort s pipeline of product
candidates also includes a potential treatment for patients with
idiopathic Parkinson s disease.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort,
Inc.
XNPT2F
Thursday, July 16, 2015
CHICAGO--(BUSINESS WIRE)--InnerWorkings, Inc. About Kamagra Oral Jelly (Sildenafil Citrate) with no prescription (NASDAQ: INWK), the leading marketing execution
firm, has become the exclusive North American marketing execution
partner of AstraZeneca, one of the world’s largest biopharmaceutical
companies that operates in more than 100 countries. Naprosyn (Naproxen) with free prescription Under the seven-year
agreement, InnerWorkings will manage AstraZeneca’s marketing print
operations across North America, which will improve AstraZeneca’s
transparency and reporting as well as strengthen its brand impact.
Strategically placed across the U.S., InnerWorkings’ three onsite teams
based in Delaware, Maryland, and Pennsylvania will help AstraZeneca
sharpen its financial visibility, unify its brands, and enhance its
marketing effectiveness. Kamagra Jelly (Sildenafil Citrate) with no prescription By tapping InnerWorkings’ $1 billion-dollar
buying power, AstraZeneca will gain vital insights, promote
sustainability, and refine its marketing spend.
“Our new partnership will streamline our marketing and sales collateral
and provide an unprecedented level of detail and control,” said Ed
McAndrews, Head of Procurement, North America at AstraZeneca. About Diabose with free prescription “With
InnerWorkings at our side, we can maximize our marketing resources while
retaining brand consistency.”
In addition to AstraZeneca, InnerWorkings also serves top-tier global
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benefit from InnerWorkings’ leverage, global reach, and ability to
navigate the most sophisticated marketing supply chains across the globe.
About InnerWorkings, Inc.
InnerWorkings, Inc. Buy Viagra Strong Pack-40 () with no prescription (NASDAQ: INWK) is the leading global marketing
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InnerWorkings is based in Chicago, Ill., employs approximately 1,500
individuals, and maintains 67 global offices in 30 countries. Among the
many industries InnerWorkings serves are: retail, financial services,
hospitality, consumer packaged goods, not-for-profits, healthcare, food
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information visit: .inwk.com.
Wednesday, July 15, 2015
2015 Myelofibrosis Pipeline Insights Study
. Buy Weekend Pack () with no Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/qmmhc7/myelofibrosispipe)
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The Myelofibrosis Report helps to identify emerging players with
potentially strong product information and create effective
counter-strategies to gain competitive advantage.
Myelofibrosis Pipeline Insights Report covers the Myelofibrosis pipeline
molecules at various stages of development like pre-registration phase,
clinical phases (Phase III, Phase II & Phase I), and pre-clinical and
discovery phases. Propecia (Finasteride) without prescription The Report also provides Myelofibrosis-related
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monotherapy and combination products. About Desloratadine without prescription The Report also highlights the
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- The report provides drug profiles which include product description,
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- Provides pipeline assessment by monotherapy and combination therapy
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Tuesday, July 14, 2015
Global Mixed Dyslipidemia Pipeline Insights Report 2015
. Buy Amaryl (Glimepiride) with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/v25pps/mixed)
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Monday, July 13, 2015
First real-life trial for oral cholera vaccine successful in Bangladesh
The first real-life trial of the oral cholera vaccine Shanchol has been deemed safe to use and viable for protection against the disease. Desogen (Desogestrel-Ethinyl Estradiol) with no Rx Results reveal that severe life-threatening cases of cholera was reduced by nearly 40% among those vaccinated. Rocaltrol (Calcitriol) with no Rx
Cholera a bacterial illness that typically enters the body through contaminated water or food.
The study, published in The Lancet, examined the drug s effectiveness in urban Bangladesh where the disease is endemic. Buy Desogen (Desogestrel / Ethinyl estradiol) without prescription The findings represent a huge step toward controlling outbreaks and developing effective mass vaccination programs.
The drug is one of two internationally licensed cholera vaccines currently available. D4T pill with no Rx Cholera vaccines are not a new development and have been used to protect travelers from Western countries for more than a decade, but never have they been used for widespread control of the disease in an endemic region.
Although the vaccine is effective, easy to administer and relatively inexpensive to produce, it has never been tested on a mass group in real-life conditions until now. Buy Amaryl (Glimepiride) with free prescription The study included almost 27,000 residents aged one year and older from the urban slums of Mirpur, in the city of Dhaka. Buy Puffy Eye Treatment online The area poses an extremely high risk of cholera infection in the area due to overcrowding and poor sanitation. http://anti-infectives-opinion.blogspot.com
Researchers conducted a double-blind, cluster-randomized, placebo-controlled trial. Residents were prescribed one of the following:
An oral cholera vaccine
An oral cholera vaccine plus behavioral change program to improve hand-washing and to provide clean drinking water
No intervention at all.
The vaccine was administrated in two doses 14 days apart through routine government health services, and the publicity campaign for vaccination was well accepted by the local community. However, just over half of the residents in the two intervention groups received the complete number of doses.
Despite this, the vaccination showed promising results. The overall incidence of severely dehydrating cholera fell by 37% after two years in the vaccination group and by 45% when used in combination with the hand washing and clean drinking water program.
Analysis of individual protection showed the vaccine gave 53% protection against cholera during the two-year follow-up.
There were no serious adverse effects from the vaccine; the majority of reactions were mild or moderate. The most common were acute watery diarrhea, vomiting, abdominal pain and fever. Lead author Dr. Firduausi Qadri from the International Centre for Diarrhea Disease Research, Bangladesh, hopes the findings act as a springboard for future development:
"Our findings show that a routine oral cholera vaccination program in cholera-endemic countries could substantially reduce the burden of disease and greatly contribute to cholera control efforts. The vaccine is cheap: two doses cost US $3.7, around a third of the price of the other licensed vaccine Dukoral."
Only part of the solution
Worldwide, cholera affects 3-5 million people, and over 1 billion are estimated to be at risk of disease. The disease remains a danger in more than 50 countries where it is endemic such as Bangladesh. Although the results of the study are promising, Dr. Qadri believes a vaccine is only part of the solution. She explains:
"Ultimately, the key to controlling cholera is clean water and adequate sanitation, which half the developing world (around 2.5 billion people) lack, but this remains a rather difficult reality for the world s poorest nations as well as those affected by climate change, war and natural disaster."
Earlier this year, the Nepal Earthquake caused millions to be at risk of a cholera outbreak in the aftermath of the disaster.
Maureen O Leary and Kim Mulholland from the London School of Hygiene & Tropical Medicine, echo Dr. Qadri s comments, saying a vaccine should "not supersede efforts to reduce risky behaviors."
Cholera is a diarrheal illness caused by the bacteria Vibrio cholera and most commonly enters the human ecosystem through contaminated water or food. If untreated, the disease can have high fatality rates, especially among young children and babies. The cholera epidemic in parts of Africa has been ongoing for more than 30 years, due to inadequate sanitation and water treatment systems.
Written by Peter Lam
Sunday, July 12, 2015
Tours of Iraq and Afghanistan highlight those soldiers at highest suicide risk
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Researchers have analyzed data from 9,791 Army personnel who attempted suicide during the wars in Afghanistan and Iraq, identifying risk factors for enlisted soldiers and officers.
Officer ranks in the Army were at much lower risk for suicide than regular enlisted soldiers.
According to the study in JAMA Psychiatry, from 2004 through 2009, the Army experienced the longest sustained increase in suicide rates relative to the other US military branches (Navy, Marines and Air Force). About Cordarone (Amiodarone) with no Rx Nonfatal attempts rose sharply in line with an increase in fatal attempts.
Dr. Sporanox (Itraconazole) with no Rx Robert Ursano, of the Uniformed Services University of the Health Sciences in Bethesda, MD, and coauthors identified risk factors among the data. About Septilin () without prescription Enlisted soldiers had higher odds for a suicide attempt if they were:
Female
Had entered the Army at age 25 years or older
Were currently 29 years old or younger
Had not completed high school
Were in their first 4 years of service
Had a mental health diagnosis during the previous month.
The research finds that female enlisted soldiers are more than twice as likely as male enlisted soldiers to attempt suicide in spite of accounting for only 13.7% of the active-duty regular Army - so may be considered for risk assessment interventions, say the authors.
The researchers estimates showed that soldiers were more likely to get into a suicidal state than their managing officers.
Enlisted women had nearly 13 times the risk of female officers for a suicide attempt; and enlisted soldiers who entered the Army at 25 years or older had more than 16 times the risk of officers in the same age group.
The authors conclude:
"Enlisted soldiers in their first tour of duty account for most medically documented suicide attempts. Cyclogyl with no Rx Risk is particularly high among soldiers with a recent mental health diagnosis.
A concentration of risk strategy that incorporates factors such as sex, rank, age, length of service, deployment status and mental health diagnosis into targeted prevention programs may have the greatest effect on population health within the US Army."
Dr. Artane (Trihexyphenidyl) without Rx Ursano and team used data on documented suicide attempts in active-duty US Army members during the wars in Afghanistan and Iraq from the Army Study to Assess Risk and Resilience in Service members (Army STARRS).
Higher ranks at lower risk
While enlisted soldiers constituted 83.5% of active-duty regular Army soldiers, they accounted for almost all cases of suicide attempt (98.6%, or 9,650 cases).
This equated to an overall rate of 377 per 100,000 person-years during the study period.
Officer ranks (both commissioned and warrant) accounted for 16.5% of the regular Army but only 1.4% of suicide attempts (141 cases), equating to an overall rate of 27.9 per 100,000 person-years.
The peak time for suicide risk in enlisted soldiers was the second month of duty, after which the risk fell as length of service increased. Buy Pomegranate online
The groups showing lower likelihood of a suicide attempt were:
Black, Hispanic or Asian race or ethnicity
Currently deployed enlisted soldiers (as compared with other enlisted soldiers).
The study authors make this recommendation:
"Future studies should examine suicide attempt risk in the context of other military characteristics (for example, military occupational specialty, number of previous deployments, history of promotion and demotion) and mental health indicators (for example, number and types of psychiatric diagnoses, treatment history)."
Written by Markus MacGill
Saturday, July 11, 2015
People with schizophrenia have more rare genetic mutations
. Buy Natural Soap online chizophrenia is a common, complex disorder that appears to arise from a number
of factors, some of which are genetic. http://allegra-opinion.blogspot.com Avapro (Irbesartan) with no Rx Now, a new study of the genetic mutations
associated with schizophrenia has deepened our understanding of its genetic
structure.
The DNA screening study found that patients with schizophrenia
had more rare variants of genes that code for proteins than people not affected by the condition.
The international study, led by the University of California Los Angeles (UCLA), is
published in the journal Nature Communications.
There, the researchers describe how after screening for hundreds of thousands of
genetic variants in people with and without schizophrenia, they found certain types -
rare mutations that code for proteins - occur more frequently in people with the
condition.
First author Dr. Viagra Soft (Sildenafil Citrate) without prescription Loes Olde Loohuis, of UCLA s Center for Neurobehavioral Genetics,
says:
"While we cannot point to specific mutations that play a causal role in
schizophrenia, we show that schizophrenia patients collectively have more of these
mutations than unaffected individuals."
Mutations in genes that code for proteins play a key role in the development of the
brain before birth, notes senior author Roel Ophoff, a professor in psychiatry and human
genetics at UCLA, who adds:
"Our finding further supports the hypothesis that schizophrenia is a disorder that may
originate during the early stages of brain development."
Schizophrenia is a common disorder characterized by hallucinations, delusions and
disorganization, that can significantly impair quality of life for patients and their
families. Buy Advair Diskus (Salmeterol+Fluticasone) with no prescription In the US, around 2-3 million people have the condition.
Rare coding variants contribute to complex genetic architecture of
schizophrenia
Fast facts about schizophrenia
Schizophrenia is a condition that affects thinking, feeling and behavior and causes
people to have abnormal experiences
The condition will affect around 1 in every 100 people in their lifetime
Contrary to what many believe, people with schizophrenia are rarely violent - they
are more likely to be victims of violence by others.
Find out more about schizophrenia
For the study, the team used a commercially available DNA screening tool to search for
250,000 coding variants in 1,042 schizophrenia patients from the Netherlands and 961
unaffected individuals.
A coding variant is where a gene or sequence of DNA that contains instructions for
making a protein is slightly altered, thus raising the chance that the associated protein
may cause malfunction in the cell in which it is made.
The results of the DNA screening showed that the patients with schizophrenia
had more of the variants than patients without schizophrenia.
The researchers confirmed these findings in another study group of more than 13,000
people with and without schizophrenia.
Prof. Buy Colgout with free prescription Ophoff says even though we know there is a large genetic component in
schizophrenia, we do not know enough about the underlying biology, and concludes:
"Our research shows that rare coding variants throughout the human genome
also contribute to this complex genetic architecture."
In discussing their results, the authors also note that the genes containing rare
coding variants "significantly overlap with genes expressed in fetal brain highlighting
the potential involvement of neurodevelopment" in the causes of schizophrenia.
The National Institute of Mental Health funded the research.
This work follows news of another piece of research that Medical News Today
reported recently that offers strong evidence of a
neurological cause of schizophrenia. Buy Ceftin (Cefuroxime) without prescription Writing in the journal Neuron, a team
from the University of Cardiff in the UK describes how they found schizophrenia mutations
interfere with chemical signaling in the brain.
Written by Catharine Paddock PhD
Tuesday, July 7, 2015
Why are doctors so guilty of working while sick?
The results of a small survey published online by JAMA Pediatrics suggest that many clinicians show up for work when sick, despite knowing that this could put patients at increased risk.
Previous studies have shown that sick health care workers are the main source of influenza, Staphylococcus aureus and Norovirus within health care facilities.
Infections occurring while a patient is being treated can significantly exacerbate their illness and also lead to increased costs. Anafranil (Clomipramine) without prescription Previous studies have shown that sick health care workers are the main source of influenza, Staphylococcus aureus and Norovirus within health care facilities.
Newborn babies and people with compromised immune systems are known to be especially at risk from these infections, which can prove fatal.
To find out why physicians and advanced practice clinicians continue to work while sick, despite the risks, researchers at the Children s Hospital of Philadelphia, PA, polled workers at their hospital in an anonymous survey.
A total of 280 attending physicians and 256 advanced practice clinicians - including registered nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives - completed the survey.
The vast majority of respondents - 95.3% - agreed that patients are put at risk by health care providers working while sick. Xalatan (Latanoprost) However, 83.1% of respondents reported working while sick at least once in the past year, and 9.3% reported working while sick at least five times.
Physicians and advanced practice clinicians reported the following reasons why they continued to work while sick:
Not wanting to let colleagues down (98.7%)
Staffing concerns (94.9%)
Not wanting to let patients down (92.5%)
Fear of being ostracized by colleagues (64%)
Concerns about the continuity of care (63.8%).
Resourcing, stigma and culture of soldiering on contribute to problem
Analyzing the comments provided by respondents, the researchers found three main areas that drive health care providers to continue working while ill. Glucovance (Metformin/Glyburide) with no Rx These are logistical or resource problems with arranging for someone to cover their work, a culture of reporting for work unless extremely ill, and ambiguity over what symptoms make someone too sick to work.
The authors write:
"The study illustrates the complex social and logistic factors that cause this behavior. Buy Clopidogrel without prescription These results may inform efforts to design systems at our hospital to provide support for attending physicians and [advanced practice clinicians] and help them make the right choice to keep their patients and colleagues safe while caring for themselves."
Dr. Buy Cialis Professional (Tadalafil) with no prescription Jeffrey R. Buy Molds & Dust online Starke, of the Baylor College of Medicine, Houston, TX, and Dr. http://doctor-answers.blogspot.com/ Mary Anne Jackson, University of Missouri-Kansas City School of Medicine write in an accompanying editorial that a culture change is required in order to decrease the stigma associated with not turning up for work when ill.
To do this, they argue that health care workers require a "more equitable system of sick leave."
"Identifying solutions to prioritize patient safety must factor in workplace demands and variability in patient census and emphasize flexibility," they add. "Also essential is clarity from occupational health and infection control departments to identify what constitutes being too sick to work."
Written by David McNamee
Universal flu vaccine steps closer
Flu vaccines in the US are made to target a small number of viral strains based on public health experts predictions. About Levitra Super Force (Vardenafil + Dapoxetine) without Rx Scientists hope that, one day, a universal flu vaccine will be developed that will be effective against all strains, and the findings of a new study may take researchers one step closer to this goal.
Influenza is dangerous in adults aged over 65, who are most likely to have serious complications from the illness.
The study, published in Cell, found that chemical modifications to a specific region in antibodies could be used to improve current flu vaccines.
"We believe these results may represent a preliminary step toward a universal flu vaccine, one that is effective against a broad range of the flu viruses," states senior author Jeffrey Ravetch, head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at the Rockefeller University, New York.
Vaccines in the US are typically formulated to target H1 and H3 influenza A viruses along with influenza B strains predicted by experts to be prevalent during the coming flu season. Buy Antabuse (Disulfiram) without Rx If the experts predictions are inaccurate, however, then the vaccines are rendered ineffective.
Just this January, the Centers for Disease Control and Prevention (CDC) reported that this season s flu vaccine was only 23% effective across all age groups, due to a large proportion of this season s viruses being "drift variants."
"While the conventional flu vaccine protects only against specific strains, usually three of them, our experiments show that by including modified antibodies within the vaccine it may be possible to elicit broad protection against many strains simultaneously," explains Ravetch.
Influenza can be a dangerous illness - particularly in adults over the age of 65 and people with other health conditions. Furoxone (Furazolidone) without Rx The American Lung Association state that 90% of deaths from influenza occur in adults older than 65.
It is a difficult virus for scientists to target with vaccines due to the wide variety of strains that exist, with new strains emerging regularly. About Cifran without prescription Because of how elusive the virus can be, a universal vaccine represents a dream goal for scientists and has been the focus of many research projects.
The new study revolves around a new strategy involving the Fc region of antibodies - the region that connects with immune cells. Buy Dostinex (Cabergoline) The researchers, led by Taia Wang and Jad Maamary, already knew that modifying the Fc region affected how the antibodies interacted with immune cells, and so the team set out to investigate how changes to the region might improve an immune response.
Efficacy of improved vaccine: no small accomplishment
Healthy volunteers were vaccinated with a seasonal flu vaccine containing an inactivated strain of the H1N1 virus - also known as swine flu. Buy Liquid Multi Vitamin online Using blood samples, the researchers tracked how the participants immune systems responded, looking for chemical modifications to antibodies against a surface protein.
Around a week later, the researchers noticed an increase in the number of sialylated antibodies present. http://doctoranswers.wordpress.com Sialic acid is a molecule crucial to signaling, meaning that the presence of these antibodies indicated a positive response to the vaccine.
Experiments on cell cultures and mice revealed that sialylated Fc regions bind to a receptor protein called CD23 on specific immune cells called B cells. In turn, CD23 activates another receptor known as FcyRIIB that discourages B cells from producing low-affinity antibodies.
In short, sialylated Fc regions lead to the activation of B cells producing the highest affinity antibodies. The researchers found that this higher affinity resulted in broad protection against influenza viruses from the H1 subtype (to which H1N1 belongs).
Using this discovery, the researchers modified the H1N1 vaccine by adding sialylated antibodies against the virus protein. The new and improved vaccine was then tested on mice.
"When we immunized mice with just the H1 protein from one strain or with the sialylated complexes containing the same viral protein, we found both offered equal protection against the same strain of flu," explains Maamary. "However, when we exposed them to strains expressing different versions of the H1 protein, only the sialylated immunizations offered protection."
Wang believes the new mechanism they have uncovered could potentially be utilized to reduce the rates of morbidity and mortality attributable to seasonal influenza virus infections.
"We are now looking into applying this strategy toward improving existing vaccines; ideally, this would result in a vaccine that provides lifelong immunity against flu infections," she states.
Earlier this year, Medical News Today reported on a study suggesting that a newly discovered class of antibodies could lead to a universal flu vaccine "within 5 years."
Written by James McIntosh
Saturday, July 4, 2015
Genetic variation influences effectiveness of anti-diabetic drug
Friday, July 3, 2015
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. Buy Uroxatral (Alfuzosin) without prescription announced today that the United States Food and Drug
Administration (FDA) accepted for review Pfizer’s new drug application
(NDA) for XELJANZ® (tofacitinib citrate) 11 mg once daily
modified release tablets for the treatment of moderate to severe
rheumatoid arthritis (RA) in patients who have had an inadequate
response or intolerance to methotrexate (MTX). Claritin (Loratadine) The FDA has provided an
anticipated Prescription Drug User Fee Act (PDUFA) action date in
February 2016 for the NDA.
The NDA for XELJANZ 11 mg once daily modified release is based on data
from a clinical pharmacology program designed to demonstrate equivalence
in key pharmacokinetic parameters to XELJANZ 5 mg twice daily.
“This filing underscores our commitment to helping advance patient care
and our goal of providing innovative solutions for patients with RA,”
said Rory O’Connor, MD, senior vice president and head of Global Medical
Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. Buy Garcinia Cambogia () without prescription “If
approved, it would bring us one step closer to offering the first and
only once-daily oral Janus kinase inhibitor treatment for those living
with moderate to severe RA who have had an inadequate response or
intolerance to methotrexate.”
As the developer of XELJANZ, Pfizer is a leader in the research of this
new class of medications. About Carbidopa with no Rx XELJANZ is approved in 40 countries around the
world for the treatment of moderate to severe rheumatoid arthritis (RA). Hair Loss Cream () without Rx
In the United States, XELJANZ has a boxed warning for serious infections
and malignancies.
About the XELJANZ Clinical Development Program
Pfizer is committed to building on the science and understanding of JAK
inhibition and XELJANZ through a robust clinical development program in
a range of immune-mediated inflammatory conditions in the areas of
rheumatology, dermatology and gastroenterology. Buy Hand Cream online A supplemental new drug
application for XELJANZ 10 mg and 5 mg tablets twice daily is currently
under review with the FDA for the treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy. http://doctorconsult.wordpress.com The benefit:risk profile of XELJANZ in
RA has been studied in approximately 6,200 patients in the global
clinical development program for XELJANZ in moderate to severe RA.
XELJANZ U.S. Label Information
XELJANZ is a prescription medicine called a Janus kinase (JAK)
inhibitor. The recommended dose is 5 mg twice-daily (BID). XELJANZ is
used to treat adults with moderately to severely active rheumatoid
arthritis in which methotrexate did not work well. XELJANZ may be used
as a single agent or in combination with MTX or other non-biologic
disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ in
combination with biologic DMARDs or potent immunosuppressants, such as
azathioprine and cyclosporine is not recommended.
It is not known if XELJANZ is safe and effective in people with
hepatitis B or C.
XELJANZ is not for people with severe liver problems.
It is not known if XELJANZ is safe and effective in children.
Important Safety Information
XELJANZ can lower the ability of the immune system to fight
infections. Some people have serious infections while taking XELJANZ,
including tuberculosis (TB), and infections caused by bacteria, fungi,
or viruses that can spread throughout the body. Some people have died
from these infections. Healthcare providers should test patients for
TB before starting XELJANZ, and monitor them closely for signs and
symptoms of TB and other infections during treatment. People should
not start taking XELJANZ if they have any kind of infection unless
their healthcare provider tells them it is okay.
People may be at a higher risk of developing shingles.
XELJANZ may increase the risk of certain cancers by changing the
way the immune system works. Lymphoma and other cancers, including
skin cancers, have happened in patients taking XELJANZ.
The risks and benefits of treatment should be considered prior to
initiating XELJANZ in patients with chronic or recurrent infection;
who have been exposed to tuberculosis; with a history of a serious or
an opportunistic infection; who have resided or traveled in areas of
endemic tuberculosis or endemic mycoses; or with underlying conditions
that may predispose them to infection.
Viral reactivation, including cases of herpes virus reactivation
(e.g., herpes zoster), was observed in clinical studies with XELJANZ.
Use of live vaccines should be avoided concurrently with XELJANZ.
Update immunizations in agreement with current immunization guidelines
prior to initiating XELJANZ therapy.
Some people who have taken XELJANZ with certain other medicines to
prevent kidney transplant rejection have had a problem with certain
white blood cells growing out of control (Epstein Barr
virus-associated post-transplant lymphoproliferative disorder).
Some people taking XELJANZ get tears in their stomach or intestines.
This happens most often in people who also take nonsteroidal
anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Patients should tell their healthcare provider right away if they have
fever and stomach-area pain that does not go away, or a change in
bowel habits. XELJANZ should be used with caution in patients who may
be at increased risk for gastrointestinal perforation (e.g., patients
with a history of diverticulitis).
XELJANZ can cause changes in certain lab test results including low
blood cell counts, increases in certain liver tests, and increases in
cholesterol levels. Healthcare providers should do blood tests before
starting patients on XELJANZ and while they are taking XELJANZ, to
check for these side effects. Normal cholesterol levels are important
to good heart health. Healthcare providers may stop XELJANZ treatment
because of changes in blood cell counts or liver test results.
Use of XELJANZ in patients with severe hepatic impairment is not
recommended.
Patients should tell their healthcare providers if they plan to become
pregnant or are pregnant.
It is not known if XELJANZ will harm an unborn baby. To monitor the
outcomes of pregnant women exposed to XELJANZ, a registry has been
established. Physicians are encouraged to register patients and pregnant
women are encouraged to register themselves by calling 1-877-311-8972.
Patients should tell their healthcare providers if they plan to
breastfeed or are breastfeeding. Patients and their healthcare
provider should decide if they will take XELJANZ or breastfeed. They
should not do both.
In carriers of the hepatitis B or C virus (viruses that affect the
liver), the virus may become active while using XELJANZ. Healthcare
providers may do blood tests before and during treatment with XELJANZ.
Common side effects include upper respiratory tract infections (common
cold, sinus infections), headache, diarrhea, and nasal congestion,
sore throat, and runny nose (nasopharyngitis).
Please click the direct link to the full prescribing information for
XELJANZ, including boxed warning and Medication Guide: labeling.pfizer.com/ShowLabeling.aspx?id=959.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease
that causes a range of symptoms, including stiffness and swelling in the
joints,1,2 particularly those in the hands, feet and knees.3
Although the exact cause of RA is unknown,1 it is considered
to be an autoimmune disease, because the immune system in people with RA
mistakes the body’s healthy tissues for a threat and attacks them.3 Some
people are at increased risk of developing RA, including people with a
family history of RA, smokers and women.3 Three times as many
women are affected by RA compared to men.2 RA affects
approximately 23.7 million people4 worldwide and 1.6 million
people in the United States.5,6 It can develop at any time
during adulthood, but it usually occurs between 40 and 70 years of age.2
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 .pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
July 2, 2015. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about XELJANZ,
including its potential benefits and a potential once daily formulation
of XELJANZ that involves substantial risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the possibility of unfavorable clinical trial results,
including unfavorable new clinical data and additional analyses of
existing clinical data; whether and when any applications for XELJANZ
may be filed with regulatory authorities in any other jurisdictions;
whether and when the FDA may approve the NDA or the supplemental new
drug application and whether and when regulatory authorities in other
jurisdictions in which such applications are pending or will be
submitted may approve such applications, which will depend on the
assessment by such regulatory authorities of the benefit-risk profile
suggested by the totality of the efficacy and safety information
submitted; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of XELJANZ; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2014 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results”, as well as in
its subsequent reports on Form 8-K, all of which are filed with the SEC
and available at .sec.gov and .pfizer.com.
1 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001;
358:903-911.
2 Medline Plus, “Rheumatoid Arthritis” Accessed 11 October
2011. Available at .nlm.nih.gov/medlineplus/ency/article/000431.htm.
3 Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September
2011. Available at .mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors.
4 World Health Organization, “The Global Burden of Disease,
2004 Update.” Accessed 13 March 2012. Available at .who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
5 Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific
Types of Arthritis and Other Rheumatic Conditions in the Ambulatory
Health Care System in the United States 2001-2005. Arthritis Care and
Research. 2010. 62(4): 460- 464.
6 Howden, L., Meyer, J., 2010 U.S. Census Bureau results ---
U.S. Census Bureau, 2010 Census Summary File 1.
Faulty cellular 'garbage disposal' implicated in Alzheimer's
. http://doctorconsult.wordpress.com ne of the hallmarks of Alzheimer s disease is deposits of beta-amyloid - a
faulty protein - in the brain. Buy Uroxatral (Alfuzosin) without prescription Surrounding these deposits or plaques are abnormally
high numbers of lysosomes, tiny specialized systems that digest and dispose of
cellular garbage.
Lysosomes - in magenta - accumulate near amyloid plaques.
Alzheimer s disease is the most common form of dementia. Claritin (Loratadine) It affects the part of
the brain that controls thought, memory and language.
The disease begins with mild memory loss and progresses to the point where the
person affected struggles to carry on a conversation and respond to what is
happening around them.
According to the Centers for Disease Control and Prevention, in 2013, as many as
5 million Americans aged 65 years or older had Alzheimer s disease, and the number
is expected to rise to 13.8 million by 2050.
When scientists first found - around 50 years ago - that beta-amyloid deposits
in the brains of people with Alzheimer s disease were surrounded by massive
accumulations of lysosomes, they assumed they were there to help degrade and clear
away the faulty protein.
Now, a new study from Yale University of New Haven, CT, suggests not only is it
not as straightforward as this, but the opposite could be happening.
The Yale team found that the lysosomes surrounding the deposits of
beta-amyloid are faulty, and instead of working against Alzheimer s progression,
may even be contributing to it.
The researchers report their findings in the Proceedings of the National
Academy of Sciences.
They suggest the discovery could lead to new types of treatment that correct the
faulty lysosomes so they can do their job properly, clear away the beta-amyloid
and stop it clogging the brain.
Vicious cycle
In the study paper, the Yale team describes how the lysosomes build up in swollen axons or nerve
fibers that contact the amyloid deposits outside the brain cells.
They found that the lysosomes have abnormally high levels of beta-secretase, the
enzyme that triggers the production of the toxic beta-amyloid protein.
The researchers suggest the faulty lysosomes are not able to break down the
enzyme because they are not fully mature. Buy Garcinia Cambogia () without prescription To become mature, they have to travel
along the axons. About Carbidopa with no Rx But the beta-amyloid plaques block their ability to do this, which
results in more accumulation of beta-secretase, which in turn triggers more beta-amyloid.
First author Swetha Gowrishankar, a postdoctoral scientist in the lab of senior
author Shawn Ferguson, assistant professor of cell biology, sums up the
finding:
"We think this represents a vicious circle."
Put simply, to be able to do their job of eliminating the enzyme that boosts
Alzheimer s plaques, the lysosomes have to be able to travel and mature. Hair Loss Cream () without Rx But their
means to do this is blocked by Alzheimer s plaques.
The team now plans to test in mice engineered to develop Alzheimer s whether
tweaking genes to help the faulty lysosomes digest the beta-secretase protects
against disease progression.
Faulty lysosomes have also been implicated in other neurodegenerative
diseases including Parkinson s and frontotemporal dementia, they note.
Funding for the study came from the Howard Hughes Medical Institute, the Ellison
Medical Foundation, the National Institutes of Health, and the Consortium for
Frontotemporal Dementia Research.
Meanwhile, Medical News Today recently learned how high blood sugar may contribute to Alzheimer s
disease by speeding up the production of beta-amyloid. Buy Hand Cream online A study conducted in mice
found that a doubling of blood glucose led to 20% higher levels of the protein.
Written by Catharine Paddock PhD
Faulty cellular 'garbage disposal' implicated in Alzheimer's
. http://doctorconsult.wordpress.com ne of the hallmarks of Alzheimer s disease is deposits of beta-amyloid - a
faulty protein - in the brain. Buy Uroxatral (Alfuzosin) without prescription Surrounding these deposits or plaques are abnormally
high numbers of lysosomes, tiny specialized systems that digest and dispose of
cellular garbage.
Lysosomes - in magenta - accumulate near amyloid plaques.
Alzheimer s disease is the most common form of dementia. Claritin (Loratadine) It affects the part of
the brain that controls thought, memory and language.
The disease begins with mild memory loss and progresses to the point where the
person affected struggles to carry on a conversation and respond to what is
happening around them.
According to the Centers for Disease Control and Prevention, in 2013, as many as
5 million Americans aged 65 years or older had Alzheimer s disease, and the number
is expected to rise to 13.8 million by 2050.
When scientists first found - around 50 years ago - that beta-amyloid deposits
in the brains of people with Alzheimer s disease were surrounded by massive
accumulations of lysosomes, they assumed they were there to help degrade and clear
away the faulty protein.
Now, a new study from Yale University of New Haven, CT, suggests not only is it
not as straightforward as this, but the opposite could be happening.
The Yale team found that the lysosomes surrounding the deposits of
beta-amyloid are faulty, and instead of working against Alzheimer s progression,
may even be contributing to it.
The researchers report their findings in the Proceedings of the National
Academy of Sciences.
They suggest the discovery could lead to new types of treatment that correct the
faulty lysosomes so they can do their job properly, clear away the beta-amyloid
and stop it clogging the brain.
Vicious cycle
In the study paper, the Yale team describes how the lysosomes build up in swollen axons or nerve
fibers that contact the amyloid deposits outside the brain cells.
They found that the lysosomes have abnormally high levels of beta-secretase, the
enzyme that triggers the production of the toxic beta-amyloid protein.
The researchers suggest the faulty lysosomes are not able to break down the
enzyme because they are not fully mature. Buy Garcinia Cambogia () without prescription To become mature, they have to travel
along the axons. About Carbidopa with no Rx But the beta-amyloid plaques block their ability to do this, which
results in more accumulation of beta-secretase, which in turn triggers more beta-amyloid.
First author Swetha Gowrishankar, a postdoctoral scientist in the lab of senior
author Shawn Ferguson, assistant professor of cell biology, sums up the
finding:
"We think this represents a vicious circle."
Put simply, to be able to do their job of eliminating the enzyme that boosts
Alzheimer s plaques, the lysosomes have to be able to travel and mature. Hair Loss Cream () without Rx But their
means to do this is blocked by Alzheimer s plaques.
The team now plans to test in mice engineered to develop Alzheimer s whether
tweaking genes to help the faulty lysosomes digest the beta-secretase protects
against disease progression.
Faulty lysosomes have also been implicated in other neurodegenerative
diseases including Parkinson s and frontotemporal dementia, they note.
Funding for the study came from the Howard Hughes Medical Institute, the Ellison
Medical Foundation, the National Institutes of Health, and the Consortium for
Frontotemporal Dementia Research.
Meanwhile, Medical News Today recently learned how high blood sugar may contribute to Alzheimer s
disease by speeding up the production of beta-amyloid. Buy Hand Cream online A study conducted in mice
found that a doubling of blood glucose led to 20% higher levels of the protein.
Written by Catharine Paddock PhD
Wednesday, July 1, 2015
Drink water responsibly only drink when thirsty to avoid health risks
Keeping hydrated is important when exercising, but drinking too much can be hazardous - in some cases even resulting in death. About Skelaxin (Metaxalone Mr) without Rx A panel of experts has published new guidelines to avoid fatal overconsumption of fluids, recommending that athletes only drink when they are thirsty.
New guidelines suggest that only drinking when thirsty is the healthiest way for athletes to keep hydrated, reducing the risk of exercise-associated hyponatremia.
Too much water or sports drinks can lead to a condition called exercise-associated hyponatremia (EAH), whereby the kidneys are unable to excrete the excess water in the body completely. Buy Diflucan (Fluconazole) with no Rx As a result, the sodium in the body becomes diluted, causing dangerous swelling in cells.
While mild symptoms of EAH include dizziness, nausea and puffiness, in severe cases the condition can lead to confusion, seizures, coma and even death. Buy Super Active Pack-20 () with no Rx At present, at least 14 athletes are estimated to have died as a result of EAH. Cabgolin without Rx
According to the authors, it is not just athletes engaging in strenuous exercise such as hiking and marathons that are susceptible to the condition. About Kamagra Pack-15 () Cases have also been reported among people participating in lawn bowls and yoga.
The new 2015 EAH Consensus Guidelines, published in the Clinical Journal of Sport Medicine, suggest that there is a simple way for athletes to avoid these risks - just follow the natural thirst stimulus when it comes to drinking.
"Using the innate thirst mechanism to guide fluid consumption is a strategy that should limit drinking in excess and developing hyponatremia while providing sufficient fluid to prevent excessive dehydration," the authors state.
Many experts recommend drinking more water than usual in hot weather to improve the body s chances of keeping cool and reducing the risk of heat-related illness like heat cramps and heat stroke. Buy General Multi Vitamin online Several groups have previously advised against waiting until feeling thirsty before drinking.
However, the authors state that this advice is largely meant for situations where people sweat much more frequently, and that the advice has helped foster the idea that thirst is a poor guide for knowing when to drink.
"Muscle cramps and heat stroke are not related to dehydration," says panel member Dr. http://webmdmagazine.wordpress.com James Winger, an associate professor in the Department of Family Medicine of Loyola University Chicago Stritch School of Medicine. "You get heat stroke because you re producing too much heat."
Drinking when not thirsty is potentially disastrous
According to Dr. Winger, modest to moderate levels of dehydration can be tolerated by otherwise healthy athletes, with athletes capable of losing up to 3% of their body weight while exercising due to dehydration and it not compromising their performance.
Writing in an associated editorial, panel member Dr. Mitchell H. Rosner, from the Division of Nephrology at University of Virginia Health System, states that inaccurate statements can lead to dangerous behaviors and subsequent EAH:
"In all cases, blanket statements that can be found on the Internet such as don t wait until you feel thirsty make little sense for the majority of casual athletes and have the potential for disastrous consequences as they promulgate the idea that near constant fluid ingestion during athletic events is a reasonable and even necessary thing to do."
The authors of the guidelines also discuss how EAH can be treated. They state that a concentrated 3% sodium solution - three times the concentration found in regular saline solution - can be used to treat severe life-threatening cases.
They also recommend that prospective and clinical trials should be conducted in order to assess the success of the "drink to thirst" strategy, along with further research into whether EAH increases the risk of long-term health problems and whether there are genetic markers that give people a predisposition toward the condition.
For Dr. Rosner, the immediate goal is that no other athletes die from EAH. "The consensus group feels that EAH is completely avoidable and with training and education regarding safe drinking/hydration that this goal is achievable," he concludes.
Previously, Medical News Today reported on research that suggested extreme levels of exercise could lead to blood poisoning.
Written by James McIntosh
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