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Sunday, December 6, 2015
Sunovion Announces Results of Health Outcomes Analyses Exploring the Effectiveness of Aptiom® (eslicarbazepine acetate) in People with Partial-Onset Seizures
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion
Pharmaceuticals Inc. About Lamprene (Clofazimine) with free prescription (Sunovion) announced results of Health
Economics and Outcomes Research (HEOR) analyses from two Phase 3 Aptiom®
(eslicarbazepine acetate) monotherapy clinical trials; and a claims
analysis of a large database of patients with epilepsy. Buy Minocin (Minocycline) without Rx The results were
presented during the 69th American Epilepsy Society (AES)
Annual Meeting in Philadelphia.
In August 2015, Sunovion announced
that the U.S. Diabecon () with free Rx Food and Drug Administration (FDA) approved the use of
APTIOM as monotherapy for the treatment of partial-onset seizures. Iobet without prescription
APTIOM may be used as monotherapy in people who initiate treatment for
the first time or convert from other antiepileptic drugs (AEDs) to
APTIOM.
A post-hoc pooled analysis of two historical-controlled Phase 3 APTIOM
monotherapy clinical trials (Studies 093-045 and 093-046) showed that
patients with partial-onset seizures who achieved a clinical response
after converting from a multi-AED regimen to APTIOM monotherapy
experienced quality of life improvements after 10 weeks. Buy Calan Sr (Verapamil) with free prescription A separate
analysis of these studies also showed that patients with partial-onset
seizures experienced statistically and clinically significant
improvements in depressive symptoms after 10 weeks, following successful
conversion from their current AED regimen to APTIOM monotherapy.
During AES, Sunovion also presented an analysis from the IMS PharMetrics
Plus database. Buy Hypoallergenic Vitamin C online The results indicated that, after controlling for
baseline confounders, patients initiating AED therapy with one pill/day
had fewer annual hospitalizations and emergency room visits than
initiating AED therapy with two or more pills/day.
“Seizures account for one million emergency department visits every
year, and epilepsy has significant impacts on a person’s ability to
drive or maintain employment,” said Krithika Rajagopalan, Head of Global
Health Economics and Outcomes Research, Sunovion. http://medicalquestionanswers.wordpress.com “Quality of life
assessments provide insights into measurable factors that are important
in determining potential treatment outcomes. These results suggest
improved seizure control with AED monotherapy is correlated with overall
improvements in specific aspects of daily life, as well as fewer
hospitalizations. Sunovion is committed to providing health outcomes
data that may contribute to improved treatment approaches for people
living with partial-onset seizures.”
Summary of Highlighted HEOR Poster Presentations
Quality of Life Improvement among Patients with Refractory
Partial-Onset Seizures: A Clinical Trial Analysis of Patients who
Responded to Eslicarbazepine Acetate Monotherapy (Poster 1.182,
Presented Saturday, December 5, 2015, 12:00 p.m. – 6:00 p.m. ET)
Pooled data from two historical-controlled Phase 3 studies (093-045 and
093-046) evaluated patients who had completed 10 weeks of APTIOM
monotherapy (n=224) for change in health-related quality of life, using
Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire. The QOLIE-31 is
an instrument that assesses daily functioning and overall well-being in
patients with epilepsy. The mean change in QOLIE-31 Total Score and
seven subscale scores from baseline to Week 18 were compared to standard
minimal clinically-important difference (MCID) change scores. The
results showed that the mean change in QOLIE-31 Total Score and five of
the seven subscales (Medication Effects, Seizure Worry, Social
Functioning, Overall Quality of Life, Cognitive Functioning, and
Energy/Fatigue) were greater than their respective MCIDs; these changes
were statistically significant for Medication Effects (p=0.011), and
Social Functioning (p=0.008).
Change in Depressive Symptoms Among Patients With Refractory
Partial-Onset Seizures Treated With Eslicarbazepine Acetate Monotherapy:
A Pooled Analysis of Clinical Trials (Poster 2.249, Presented Sunday,
December 6, 8:00 a.m. – 4:00 p.m. ET)
Pooled data from two historical-controlled Phase 3 studies (093-045 and
093-046) evaluated patients who had completed 10 weeks of APTIOM
monotherapy (Completers, n=224), as well as a subset of these patients
who achieved a clinical response after 10 weeks of treatment
(Responders, n=117), for change in depressive symptoms, using the
Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire. The
MADRS is a 10-item instrument used to identify moderate-to-severe
depressive symptoms. MADRS scores were compared to 1) Population-level
MCID change scores (range: 1.3 to 1.6); and 2) Treatment effect MCID
change scores (1 point versus active treatment or 2 points versus
placebo).
Data showed that mean change in the MADRS scores was significantly
decreased (indicating a reduction in depressive symptoms) and exceeded
published MCID change scores (-2.1 for Completers and -2.6 for
Responders, p<0.001 for both). Over half of all patients in these groups
(56.3 percent of Completers and 56.4 percent of Responders) experienced
significant reductions in depressive symptoms—with most patients (90.5
percent and 87.9 percent, respectively) reporting decreased MADRS scores
of two or more points.
The Association Between Antiepileptic Drug Pill Burden at
Monotherapy Initiation and Epilepsy-Related Hospital Admissions and
Emergency Department Visits in the US (Poster 2.282, Presented Sunday,
December 6, 8:00 a.m. – 4:00 p.m. ET)
A retrospective analysis of health insurance claims data from more than
53,000 epilepsy patients who initiated AED monotherapy found that
patients who initiated with a one pill/day regimen had fewer
hospitalizations and emergency room visits over the following 12 months
compared with patients initiating with two or more AEDs. Patients
initiating with two, three, or more than three pill/day regimens had
annual hospitalization rates that were 12.5, 23.1, and 19.4 percent
higher respectively, compared to patients taking one pill/day. Patients
initiating with larger pill burdens also had significantly higher rates
of emergency room visits during the year of following-up (15.5 , 25.2,
and 15.1 percent higher for patients taking two, three, or more than
three pills/day, respectively).
About the Phase 3 Monotherapy Studies
Two identically designed Phase 3, dose-blinded, historical-controlled,
multi-center, randomized clinical trials (Studies 093-045 and 093-046)
evaluated the safety and efficacy of APTIOM (1,600 mg/day or 1,200
mg/day) as monotherapy for partial-onset seizures in patients 16 years
of age or older whose seizures were not well-controlled with other
antiepileptic drugs (AEDs).
The primary endpoint for both trials was the percentage of patients who
exited the study due to pre-defined criteria identifying worsening
seizure control, compared to historical controls from previous,
similarly designed trials of epilepsy patients converting to AED
monotherapy. Trial results showed that conversion to APTIOM monotherapy
was associated with exit rates superior to historical controls in
patients with partial-onset seizures, who were not well-controlled by
one or two current AEDs.
APTIOM administered once-daily was generally well tolerated in both dose
strengths. In the APTIOM monotherapy trials, the most common
treatment-related adverse events, headache, dizziness, fatigue,
somnolence, and nausea, were mainly mild or moderate in severity.
About Aptiom® (eslicarbazepine acetate)
APTIOM is the latest member of the dibenzazepine carboxamide family of
antiepileptic drugs (AEDs), an established class of medicines. APTIOM is
the only exclusively once-daily, non-extended release AED now
FDA-approved for use as monotherapy or adjunctive therapy for
partial-onset seizures. The precise mechanism(s) by which
eslicarbazepine, the primary active metabolite of APTIOM, exerts
anticonvulsant activity is unknown but is thought to involve inhibition
of voltage-gated sodium channels. APTIOM can be taken whole or crushed,
with or without food. APTIOM is not classified as a controlled substance
by the FDA.
The initial research and development of eslicarbazepine acetate was
performed by BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese
research-based pharmaceutical company. Subsequently, Sunovion acquired
the rights under an exclusive license to further develop and
commercialize eslicarbazepine acetate in the United States and Canada
markets from BIAL. BIAL gained approval for eslicarbazepine acetate from
the European Medicines Agency on April 21, 2009 as adjunctive therapy in
adult patients with partial-onset seizures with or without secondary
generalization. In Europe, the product is marketed under the trade name
Zebinix®. APTIOM is approved in Canada for use as adjunctive
therapy in the treatment of partial-onset seizures in patients with
epilepsy who are not satisfactorily controlled with conventional therapy.
About Epilepsy and Partial-Onset Seizures
Epilepsy is the fourth most common neurological condition, and one in 26
people in the U.S. will develop epilepsy in his or her lifetime.i
Epilepsy manifests as unprovoked seizures, which are caused by abnormal
firing of impulses from nerve cells in the brain.ii
Partial-onset seizures, the most common type of seizure, are
characterized by bursts of electrical activity that are initially
focused in specific areas of the brain and may become more widespread,
with symptoms varying according to the affected areas.iii The
unpredictable nature of seizures may have a significant impact on those
with epilepsy. Reducing the frequency of seizures may lessen the burden
of epilepsy.ii With approximately one-third of people living
with epilepsy still unable to control seizures, there continues to be a
need for new therapies.iv Up to 40 percent of people living
with epilepsy do not respond to the first or second monotherapyv,
and approximately 36 percent fail to achieve adequate control of
seizures despite the use of two or more antiepileptic medicationsvi.
Please see Important Safety Information below.
INDICATION:
Aptiom® (eslicarbazepine acetate) is a prescription medicine used alone
or with other medicines to treat partial-onset seizures.
IMPORTANT SAFETY INFORMATION:
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any
of the other ingredients in APTIOM, or oxcarbazepine.
Suicidal behavior and ideation: APTIOM may cause suicidal
thoughts or actions, depression, or mood problems. Call your doctor
right away if you experience these or any other effects or reactions:
thoughts about suicide or dying; attempting to commit suicide; new or
worse depression, anxiety, or irritability; feeling agitated or
restless; panic attacks; trouble sleeping (insomnia); acting aggressive;
being angry or violent; acting on dangerous impulses; an extreme
increase in activity and talking (mania); or other unusual changes in
behavior or mood.
Allergic reactions: APTIOM may cause serious skin rash or other
serious allergic reactions that may affect organs or other parts of your
body like the liver or blood cells. You may or may not have a rash with
these types of reactions. Call your doctor right away if you experience
any of the following symptoms: swelling of the face, eyes, lips, or
tongue; trouble swallowing or breathing; hives; fever, swollen glands,
or sore throat that do not go away or come and go; painful sores in the
mouth or around your eyes; yellowing of the skin or eyes; unusual
bruising or bleeding; severe fatigue or weakness; severe muscle pain; or
frequent infections or infections that do not go away.
Low salt (sodium) levels in the blood: APTIOM may cause the level
of sodium in your blood to be low. Symptoms may include nausea,
tiredness, lack of energy, irritability, confusion, muscle weakness or
muscle spasms, or more frequent or more severe seizures. Some medicines
can also cause low sodium in your blood. Be sure to tell your healthcare
provider about all the other medicines that you are taking.
Nervous system problems: APTIOM may cause problems that can
affect your nervous system, including dizziness, sleepiness, vision
problems, trouble concentrating, and difficulties with coordination and
balance. APTIOM may slow your thinking or motor skills. Do not drive or
operate heavy machinery until you know how APTIOM affects you.
Liver problems: APTIOM may cause problems that can affect your
liver. Symptoms of liver problems include yellowing of your skin or the
whites of your eyes, nausea or vomiting, loss of appetite, stomach pain,
or dark urine.
Most common adverse reactions: The most common side effects in
patients taking APTIOM include dizziness, sleepiness, nausea, headache,
double vision, vomiting, feeling tired, problems with coordination,
blurred vision, and shakiness.
Drug interactions: Tell your healthcare provider about all the
medicines you take, including prescription and over-the counter
medicines, vitamins, and herbal supplements. Taking APTIOM with certain
other medicines may cause side effects or affect how well they work. Do
not start or stop other medicines without talking to your
healthcare provider. Especially tell your healthcare provider if you
take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone,
clobazam, omeprazole, simvastatin, rosuvastatin, or birth control
medicine.
Discontinuation: Do not stop taking APTIOM without first talking
to your healthcare provider. Stopping APTIOM suddenly can cause serious
problems.
Pregnancy and lactation: APTIOM may cause your birth control
medicine to be less effective. Talk to your healthcare provider about
the best birth control method to use. APTIOM may harm your unborn baby.
APTIOM passes into breast milk. Tell your healthcare provider if you are
pregnant or plan to become pregnant, or are breastfeeding or plan to
breastfeed. You and your healthcare provider will decide if you should
take APTIOM. If you become pregnant while taking APTIOM, talk to your
healthcare provider about registering with the North American
Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this
registry is to collect information about the safety of antiepileptic
medicine during pregnancy. You can enroll in this registry by calling
1-888-233-2334.
Get medical help right away if you have any of the symptoms listed
above.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit .fda.gov/medwatch
or call 1-800-FDA-1088.
For more information, please see the APTIOM
Medication Guide and Full
Prescribing Information.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s spirit of innovation is driven by the conviction
that scientific excellence paired with meaningful advocacy and relevant
education can improve lives. The Company has charted new paths to
life-transforming treatments that reflect ongoing investments in
research and development and an unwavering commitment to support people
with psychiatric, neurological, and respiratory conditions. Sunovion’s
track record of discovery, development and commercialization of
important therapies has included Brovana® (arformoterol
tartrate), Latuda® (lurasidone HCI), and most recently Aptiom®
(eslicarbazepine acetate).
Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada, Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the Company’s web sites: .sunovion.com,
.sunovion.eu
and .sunovion.ca.
Connect with Sunovion on Twitter @Sunovion
and LinkedIn.
BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is under license from BIAL.
© 2015 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at .sunovion.com
References
i Institute of Medicine (IOM). 2012. “Epilepsy across the
spectrum: Promoting health and understanding.” Washington, DC: The
National Academies Press.
ii National Institutes of Health. “NINDS Epilepsy Information
Page” Accessed July 2015. <.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
iii Epilepsy Foundation. “Complex Partial Seizures.” Accessed
July 2015. <.epilepsy.com/learn/types-seizures/complex-partial-seizures>.
iv Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P.
Patterns of treatment response in newly diagnosed epilepsy. Neurology.
2012;78:1548-1554.
v Kwan P, Brodie MJ. “Early Identification of Refractory
Epilepsy.” New England Journal of Medicine (2000): 342(5):314-9. .ncbi.nlm.nih.gov/pubmed/10660394.
vi Epilepsy Foundation. “Epilepsy Foundation Position
Statement” <.epilepsycolorado.org/index.php?s=12105>.
Accessed June 2015.
Monday, November 2, 2015
Helius Medical Technologies Announces Positive Clinical Trial Results from its Multiple Sclerosis Pilot Study
Saturday, October 24, 2015
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Saturday, October 10, 2015
Samenvatting Cmed Clinical Services benoemt nieuwe Chief Medical Officer
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Monday, October 5, 2015
Genzyme Introduces “vs.MS,” a Global Initiative Aimed at Uncovering the Often Unspoken Challenges of MS to Drive Better Informed Care
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi
company, today announced a new global initiative, vs.MS, that is
designed to raise awareness of the often unspoken emotional and physical
burden of relapsing multiple sclerosis (RMS) on people living with the
disease and their care partners. About Benicar Hct (Olmesartan - Hydrochlorothiazide) with no Rx To better understand the full burden
associated with RMS, Genzyme fielded a global survey among more than
1,500 people living with RMS and their care partners across seven
countries. About Ventolin Inhaler (Albuterol) with free Rx An initial set of data from the vs.MS global survey will be
shared for the first time at the 31st Congress of the European Committee
on the Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Barcelona, Spain, October 7-10.
“As part of our ongoing commitment to help improve the lives of
people living with MS, we are proud to introduce this new global
initiative in collaboration with patients and caregivers,” said
Darlene Jody, Head of MS Medical Affairs at Genzyme. About Diamox (Acetazolamide) “At Genzyme, we
believe that when we know more, we can do more. About Fungotek with free prescription The experiences
uncovered through the vs.MS survey will help shed light on the physical
and emotional toll RMS can have, and we look forward to developing a
program that may help drive a more open exchange for better informed
care.”
While at ECTRIMS, Genzyme is bringing together thought leaders from
across the MS Community representing people living with MS, healthcare
providers specializing in the disease, and advocacy groups to review the
full vs.MS survey findings and begin developing a program that will be
rolled out to the community.
To unveil the initial vs.MS survey results at ECTRIMS, Genzyme is
hosting an interactive digital experience at their booth, as well as
sharing the findings via the @GenzymeCorp
Twitter handle. Gasex () with no prescription For each individual who participates in the interactive
digital experience and for every retweet that includes the campaign
hashtag #vsMS, Genzyme will donate 5 Euros to the Multiple Sclerosis
International Federation (MSIF) in support of the organization’s
research efforts.
Data from the vs.MS global survey will provide a glimpse into the impact
the disease may have on various aspects of day-to-day life for people
living with RMS. Buy Digestion for Pets online For example, half of respondents feel their ability to
progress in their career has changed for the worse since they were
diagnosed with RMS, and 40 percent are concerned about being able to
keep their job.
The vs.MS survey also reveals the effect of RMS on the emotional
well-being of those living with the disease and their care partners. http://asthmareview.wordpress.com For
example, more than half of respondents living with RMS feel lonely or
isolated because of their MS, while more than half of care partners do
not discuss their fear of MS progressing to avoid upsetting the person
they care for.
“The results of this global survey offer a unique look into the
realities of relapsing MS, including the challenges that people living
with MS and their care partners deal with on a daily basis,” said
Dr. Barry Singer, MD, Director of The MS Center for Innovations in Care
at Missouri Baptist Medical Center in St. Louis, MO, and a vs.MS
steering committee member. “We are hopeful that insight into the
daily struggles of those living with MS will result in better disease
management.”
The vs.MS survey was fielded among more than 1,500 people across seven
countries, including people living with RMS and RMS care partners.
Developed with input and guidance from a steering committee of leading
global neurologists specializing in MS, the online survey addressed
topics such as progression and disability; cognitive challenges;
relationship and intimacy issues; emotional burden; fatigue and
sensitivity; bladder and bowel challenges; and impact of MS on careers.
In the coming months, Genzyme will reveal the full vs.MS data set and
partner with the MS Community to encourage behavior and attitude shifts
in an effort to drive better outcomes for those affected by the disease.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative
therapies for patients affected by rare and debilitating diseases for
over 30 years. We accomplish our goals through world-class research and
with the compassion and commitment of our employees. With a focus on
rare diseases and multiple sclerosis, we are dedicated to making a
positive impact on the lives of the patients and families we serve. That
goal guides and inspires us every day. Genzyme’s portfolio of
transformative therapies, which are marketed in countries around the
world, represents groundbreaking and life-saving advances in medicine.
As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world’s largest pharmaceutical companies, with a shared
commitment to improving the lives of patients. Learn more at .genzyme.com.
Genzyme® is a registered trademark of Genzyme Corporation.
All rights reserved.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients’ needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, consumer
healthcare, emerging markets, animal health and the new Genzyme. Sanofi
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Saturday, September 26, 2015
Availability of Medical Abortion in the U.S. Continues to Provide Women Safe Alternative, 15-Years after FDA Approval
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Friday, September 11, 2015
Biogen Prices $6.0 Billion of Senior Unsecured Notes
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) announced today the pricing of four series
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$1.00 billion will mature on September 15, 2022 and will bear interest
at an annual rate of 3.625%
$1.75 billion will mature on September 15, 2025 and will bear interest
at an annual rate of 4.050%
$1.75 billion will mature on September 15, 2045 and will bear interest
at an annual rate of 5.200%
The offering is expected to close on September 15, 2015, subject to
customary closing conditions.
Biogen intends to use the net proceeds from this offering, together with
cash on hand, to fund share repurchases of its common stock under the
company’s previously authorized $5.0 billion share repurchase program,
for working capital and other general corporate purposes.
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An electronic copy of the prospectus supplement and the accompanying
base prospectus may also be obtained at no charge at the Securities and
Exchange Commission’s website at .sec.gov.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be any
sale of securities in any state or other jurisdiction where such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction, where the offer, solicitation or sale of these securities
would be unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction. Buy Cat’s Claw online The offering of
the notes may be made only by means of a prospectus supplement and the
accompanying base prospectus.
About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers to patients worldwide innovative
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conditions and autoimmune disorders. http://future-pharmaceuticals.blogspot.com Founded in 1978, Biogen is one of
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Biogen Safe Harbor StatementThis press release contains
forward-looking statements that involve risks and uncertainties,
including statements about the expected use of proceeds and timing of
completion of the offering. You should not place undue reliance on these
statements. These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in such
statements. The offering may also be adversely affected by market
conditions, adverse changes to Biogen’s business or prospects, and the
other risks and uncertainties that are described in Biogen’s filings
with the Securities and Exchange Commission. These statements are based
on current beliefs and expectations and speak only as of the date of
this press release. Biogen does not undertake any obligation to publicly
update any forward-looking statements.
Wednesday, September 2, 2015
Eosinophilic Esophagitis Pipeline Review, H2 2015 - 7 Companies & 8 Drug Profiles
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Friday, August 28, 2015
Platelet Receptor Inhibitors Pipeline Insights Review 2015
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Wednesday, August 19, 2015
Global Coronary Disease Pipeline Review 2015
. Buy Asthma online About Doxycycline (Doxycycline) with no Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/df9f4k/coronary)
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analysis at various stages covering Filed, Phase III, Phase II, Phase I,
IND filed, Preclinical, Discovery and unknown stages, therapeutics
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therapeutic development of the products. Buy Purim () with no Rx Buy Droxia (Hydroxyurea) without prescription It also has highlighted the
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Monday, July 27, 2015
Verrucous Carcinoma Global Clinical Trials Review, H1, 2015
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their recruitment status as per the site of trial conduction across the
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trials by their phase, trial status, prominence of the sponsors and also
provides briefing pertaining to the number of trials for the key drugs
for treating Verrucous Carcinoma.
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Data on the number of clinical trials conducted in North America,
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Clinical Trial Overview of Top Companies
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Wednesday, July 15, 2015
Global Mycoses Pipeline Insights Study 2015
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Tuesday, July 14, 2015
Global Meningitis Pipeline Insights Report 2015
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Monday, July 13, 2015
ESMO GI provides new insights into HCC and metastatic liver cancer
Studies presented at the European Society for Medical Oncology 17th World Congress on Gastrointestinal cancer, Barcelona, Spain,1-4 July, helped define the hepatocellular carcinoma and liver metastatic colorectal cancer patient populations in which established treatments work best and provided insights into emerging therapies.
Scientists believe there is an unmet medical need for both hepatocellular carcinoma and metastatic liver cancer.
Patients with hepatocellular carcinoma (HCC) have a poor prognosis with median survivals of 10 to 11 months despite use of sorafenib first line. Detrol La (Tolterodine) without Rx Liver metastases develop in nearly 20% of patients with stage II and 50% of patients with stage III colorectal cancer and represent the major cause death in this disease. About Rhinocort (Budesonide) Unfortunately, radical surgical resection of liver metastases is only possible in 10 to 25% of patients with CRC confined to the liver. Aralen (Chloroquine) with no prescription In most patients the number, localization and/or size of the liver metastases or poor hepatic reserve preclude resection. Buy Daclin with free prescription All this points to the unmet medical need for both HCC and metastatic liver cancer.
The latest analysis of the GIDEON study, which set out to evaluate the safety of sorafenib in a real world population of HCC patients, showed improved outcomes for patients over 70 years compared to those under 70 years. About Allegra (Fexofenadine) with free Rx The current subgroup analysis explored 278 patients from the Italian cohort of the main study, of whom 141 were older than 70 years and 133 younger.
Results showed that the median overall survival was 10 months in the younger age group versus 20 months in the older age group. Buy R-Lipoic Acid online Furthermore, elderly patients had a PFS of 6 months versus 4.1 months for younger patients; and elderly patients had a time to progression of 7.6 months versus 5 months for younger patients. http://webmd-consult.blogspot.com The authors believe that younger patients have shorter overall survivals due to more advanced disease.
The latest sub-analysis from the SIRFLOX study showed patients with metastatic colorectal cancer (mCRC) that has spread only to the liver at study entry do better with selective internal radiation therapy (SIRT) than those with more widespread metastases.
With SIRT, a technique granted CE Mark approval in the EU in 2002 for unresectable liver tumours, yttrium-9-resin microspheres (Sirtex) are delivered to the liver via a hepatic artery injection. Key to the success of the procedure is occlusion of extra-hepatic vessels to prevent deposition of radioactive microspheres outside the liver. Since there have never been large randomized controlled trials for SIRT in combination with modern first-line standard of care chemotherapy the SIRFLOX study was initiated.
Data presented at ASCO 2015 failed to show overall progression free survival advantages for patients treated with mFOLFOX6 + SIRT compared to those treated with chemotherapy alone. The findings were attributed to the inclusion of 40% of patients with extra-hepatic metastatic disease in the analysis.
In the current sub-group analysis the investigators explored the 318 patients with metastases limited to the liver at the time they entered the study separately from the 212 patients with both liver and extra hepatic metastases at study entry.
Results showed that for those treated with metastases limited to the liver median PFS in the liver was 21.1 months for those treated with chemotherapy + SIRT compared to 12.4 months for those treated with chemotherapy alone (p=0.003, HR 0.64). "These new pre-planned sub-group findings for PFS in the liver should lead oncologists to consider adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy," said Guy van Hazel, the co-principal investigator of the SIRFLOX study, from the University of Western Australia, Perth.
Rose bengal solution as hepatocellular carcinoma treatment
According to one intriguing abstract study, a single injection with PV-10 led to the complete disappearance of HCC in one patient, and colorectal liver metastases in another. PV-10, a 10% solution of rose bengal used originally to stain necrotic tissue in the cornea, has been showing promise in melanoma. A phase 2 study, presented at ESMO last year, demonstrated that 50% of patients with stage III melanoma patients who had all their cutaneous lesions injected with PV-10 achieved a complete response.
For the current study two cohorts of patients, one with non-resectable HCC (n=6) and a second with other forms of cancer metastatic to the liver (n=7, three originally colorectal tumors, two nonsmall cell lung, two melanoma and one ovarian) underwent a single percutaneous injection of PV-10 guided by CT to one target lesion in the liver at least 1 cm in diameter.
From the analysis of the first five patients (who had six tumours injected) the investigators found that two patients showed no evidence of disease at more than 40 months follow-up according to RECIST and EASL criteria. The first patient was a 68 year old male with HCC (hepatitis B and cirrhosis) alive at 54 months follow-up with no evidence of disease; while the second patient was a 61-year-old male with metastatic CRC alive at 42 months follow-up with no evidence of disease.
"Having liver cancer patients alive at up to 54 months follow-up with no evidence of disease is remarkable. This is even more extraordinary when you consider these patients received just one or two intralesional injections," says Eric Wachter, the author of the abstract who co-developed PV-10.
As with melanoma, the mechanism of PV-10 in liver cancers is believed to be due to local chemoablative effects where the agents enters lysosomes causing tumor necrosis that can stimulate immunological effects.
Furthermore, melanoma patients injected with PV-10 have been shown to have increased T cells in peripheral blood, including CD8+, CD4+, CD3+ and NKT.
Written by Janet Fricker
Sunday, July 12, 2015
People with schizophrenia have more rare genetic mutations
. Buy Pregnenalone online chizophrenia is a common, complex disorder that appears to arise from a number
of factors, some of which are genetic. http://medicalquestionanswers.wordpress.com About Coumadin (Warfarin) 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. Buy Singulair (Montelukast) 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 Herbolax () 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. About Cyclospasmol without 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. Arimidex (Anastrozole) with free Rx 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
Saturday, July 11, 2015
Food container plastics linked to hypertension
Chemicals supposed to be safe replacements for harmful chemicals in plastics are linked to hypertension and insulin resistance, a precursor to diabetes, find scientists from NYU Langone Medical Center in New York City.
Small rises in blood pressure were linked to the chemicals supposed to replace those previously found to be unsafe.
The phthalate compounds in question - di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP) - are replacements for another chemical, di-2-ethylhexylphlatate (DEHP), which the same researchers proved in previous research to have similar adverse effects.
The phthalates are meant to strengthen plastic wraps and processed food containers, among other household items.
The two new pieces of research are published in the journals Hypertension and The Journal of Clinical Endocrinology and Metabolism.
In the Hypertension study, for every 10-fold increase in the amount of phthalates consumed, there was a 1.1 millimeters of mercury (mmHg) increase in blood pressure.
In the other study, one in three adolescents with the highest DINP levels had the highest insulin resistance, while for those with the lowest concentrations of the chemicals, only 1 in 4 had insulin resistance.
Growing concerns over environmental chemicals and insulin resistance
Study leader Dr. About Avodart (Dutasteride) with free prescription Leonardo Trasande, a professor at NYU Langone, says:
"Our research adds to growing concerns that environmental chemicals might be independent contributors to insulin resistance, elevated blood pressure and other metabolic disorders."
Prof. Buy Viagra Gold (Sildenafil Citrate + L-Arginine + Giseng + Vitamin B6 + Folic Acid) with no Rx Trasande would like the 1976 Toxic Substances Control Act updated: "Our study adds further concern for the need to test chemicals for toxicity prior to their broad and widespread use, which is not required under current federal law."
Other research from Prof. Buy Theo-24 Sr (Theophylline ) with no Rx Trasande in 2013 confirmed a link between DEHP exposure and hypertension in Americans. Buy Combantrin with free Rx DEHP was used as a plasticizer but banned in Europe in 2004 - DINP and DIDP are designed to replace it. Ceclor (Cefaclor) with free Rx Perhaps the safer alternatives lie in not using plastics at all.
"Alternatives to DIDP and DINP include wax paper and aluminum wrap; indeed, a dietary intervention that introduced fresh foods that were not canned or packaged in plastic reduced phthalate metabolites substantially."
Prof. Buy Neem online Trasande adds that there are "safe and simple" steps that can limit exposure to phthalates, including:
Do not microwave food in plastic containers or covered by plastic wrap
Do not wash plastic food containers in the dishwasher, where plasticizers can leak out
Avoid phthalates by avoiding plastic containers labeled with the numbers 3, 6 or 7 inside the recycle symbol.
The results of the research come from blood and urine sample analysis of participants in the National Health and Nutrition Examination Survey (NHANES).
Since 1999, NHANES has surveyed 5,000 volunteers annually about risk factors and diseases. http://web-md.blogspot.com As part of the NYU Langone investigation, blood and urine samples were analyzed from a diverse group of children and adolescents aged between 6 and 19 years.
Blood and urine samples were collected once between 2008 and 2012, and the study volunteers blood pressure was similarly measured. Diet, physical activity, gender, race/ethnicity, income, and other factors independently associated with insulin resistance and hypertension were also factored into the researchers analysis.
Written by Markus MacGill
Tuesday, July 7, 2015
Weight-loss surgery 'highly effective' for type 2 diabetes remission
A new study suggests weight-loss surgery combined with low-level lifestyle interventions may be a more effective treatment strategy for obese patients with type 2 diabetes than lifestyle interventions alone.
While lifestyle interventions alone appear to have no effect on type 2 diabetes remission, researchers found these combined with weight-loss surgery led to remission for many obese patients with the condition.
Dr. About Apcalis Oral Jelly (Tadalafil) with no prescription Anita P. Vpxl (Vpxl) with no prescription Courcoulas, of the University of Pittsburgh Medical Center, PA, and colleagues publish their findings in JAMA Surgery.
Excess weight is a major risk factor for type 2 diabetes; more than 90% of people who have type 2 diabetes are overweight or obese.
It is recommended that obese patients with type 2 diabetes adopt lifestyle changes, such as a healthy diet and regular exercise, to help manage or treat their condition. Prandin (Repaglinide) without prescription But recently, studies have suggested weight-loss surgery, or bariatric surgery, may be just as effective as lifestyle interventions and medical therapy for obese patients with type 2 diabetes
In April 2014, for example, Medical News Today reported on a study published in the New England Journal of Medicine that found obese patients who underwent bariatric surgery were able to control their type 2 diabetes without the use of medical therapy in the 3 years following the procedure.
But Dr. Clopress without prescription Courcoulas and colleagues say "questions remain" about the efficacy of such treatment. About Cialis Pack-30 () without Rx "More information is needed about the longer-term effectiveness and risks of all types of bariatric surgical procedures compared with lifestyle and medical management for those with T2DM [type 2 diabetes mellitus] and obesity," they note.
As such, the team assessed the outcomes of 61 obese patients aged 25-55 with type 2 diabetes who were randomly assigned to receive either weight-loss surgery in the first year followed by a low-level lifestyle intervention for 2 years, or an intense lifestyle intervention for 1 year followed by a low-level lifestyle intervention for 2 years.
Subjects who underwent weight-loss surgery received one of two procedures: roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB). Buy Mullein online
RYGB involves the creation of a small stomach pouch from a portion of the stomach, which is then connected to the small intestine, bypassing the rest of the stomach and the duodenum. http://cholesterolreviews.wordpress.com LAGB involves the placement of a band around the upper part of the stomach to create a smaller stomach pouch. The band can be adjusted after the procedure to make food pass more slowly or quickly through the stomach.
Both of these procedures limit the amount of food a person can eat, making them feel full faster.
Dr. Courcoulas and colleagues assessed the incidence of partial or complete type 2 diabetes remission among all subjects after 3 years.
Weight-loss surgery led to complete type 2 diabetes remission for some obese patients
Bariatric surgery was found to be most effective for weight loss among study participants. Those who underwent RYGB lost around 25% of their body weight during follow-up, LAGB subjects lost around 15% of their body weight, while lifestyle intervention-only participants lost around 5.7%.
The team found that many participants who underwent weight-loss surgery followed by lifestyle interventions experienced partial or complete type 2 diabetes remission, while those who engaged in lifestyle interventions alone experienced no remission at all.
Of the subjects who underwent RYGB, 40% experienced partial or complete type 2 diabetes remission, while this was the case for 29% of subjects who underwent LAGB. Three subjects treated with RYGB and one treated with LAGB had complete remission.
In addition, the team found that patients who underwent weight-loss surgery were more likely to have better blood glucose control and less likely to need medication for their type 2 diabetes, compared with those who engaged in lifestyle interventions alone.
"More than two thirds of those in the RYGB group and nearly half of the LAGB group did not require any medications for T2DM treatment at 3 years," say the researchers.
One strength of this study, according to the team, is that around 40% of participants fell into the category of class 1 obesity - defined as having a body mass index (BMI) of between 30 and 35. The researchers note that weight-loss surgery is normally carried out on patients with a BMI of 40 or more, so data is lacking on the effects of weight-loss surgery for obese patients with a lower BMI.
Commenting on their findings, the team says:
"This study provides further important evidence that at longer-term follow-up of 3 years, surgical treatments, including RYGB and LAGB, are superior to lifestyle intervention alone for the remission of T2DM in obese individuals including those with a BMI between 30 and 35.
While this trial provides valuable insights, unanswered questions remain such as the impact of these treatments on long-term microvascular and macrovascular complications and the precise mechanisms by which bariatric surgical procedures induce their effects."
In an editorial linked to the study, Dr. Michel Gagner, of Florida International University in Miami, says the findings indicate the use of weight-loss surgery should be increased for obese individuals with type 2 diabetes.
"We should consider the use of bariatric (metabolic) surgery in all severely obese patients with T2DM and start a mass treatment, similar to what was done with coronary artery bypass graft more than 50 years ago," he says.
In November 2014, MNT reported on a study suggesting that weight-loss surgery may also be effective for prevention of type 2 diabetes among obese patients.
Published in The Lancet Diabetes & Endocrinology, the study found that obese patients who underwent bariatric surgery were 80% less likely to develop type 2 diabetes than those who received no obesity-related treatment.
Written by Honor Whiteman
Traders' testosterone 'makes them take financial risks'
Researchers simulating the financial trading floor in the lab have found that traders hormone levels in the stressful, competitive environment are raised, making them invest in more risky assets.
Cortisol is involved in the fight or flight response.
The study, published in Scientific Reports, found that when given doses of either cortisol or testosterone, the participants buying and selling assets among themselves invested more in risky assets.
They measured the volunteers natural hormone levels in one experiment and artificially raised them in another. About Champix (Varenicline) without Rx
"Our view is that hormonal changes can help us understand traders behavior, particularly during periods of financial instability," said Dr. Buy Amoxil (Amoxicillin) without Rx Carlos Cueva, PhD, one of the lead authors of the study, from the department of economics at the University of Alicante, Spain.
Cortisol is elevated in response to physical or psychological stress, increasing blood sugar and preparing the body for a fight-or-flight response.
The authors suggest their findings could help with the development of more stable financial institutions.
The paper s conclusion is:
"Our results suggest that changes in both cortisol and testosterone could play a destabilizing role in financial markets through increased risk taking behavior, acting via different behavioral pathways."
Dr. Allegra (Fexofenadine) Ed Roberts, from the department of medicine at the UK s Imperial College London and one of the lead authors of the study, says: "Our aim is to understand more about what these hormones do. Cilostazol without Rx Then we can look at the environment in which traders work, and think about whether it s too stressful or too competitive.
"These factors could be affecting traders hormones and having an impact on their decision-making."
Saliva samples
Some 142 volunteers, male and female, participated in the study, giving saliva samples for the measurement of the two hormones.
They played an asset trading game in groups of around 10. Diltiazem (Diltiazem Hcl) without prescription Those who had higher levels of cortisol were more likely to take risks, and high levels in the group were associated with instability in prices.
In a second experiment, 75 young men were given either cortisol or testosterone before playing the game. Buy Liver online They were tested once while on the hormone and once while on a placebo.
Both hormones had an effect toward greater risk-taking in investments. http://allergy-opinion.blogspot.com Cortisol appeared to directly affect volunteers preference for riskier assets, while testosterone seemed to increase optimism about how prices would change in the future.
Dr. Roberts says: "The results suggest that cortisol and testosterone promote risky investment behavior in the short run.
"We only looked at the acute effects of the hormones in the lab. It would be interesting to measure traders hormone levels in the real world, and also to see what the longer term effects might be."
Written by Markus MacGill
Saturday, July 4, 2015
Benefits of extracurricular sports extend into the classroom
Extracurricular sports have long been promoted as a way of keeping children healthy, but new research suggests they could also provide benefits in the classroom, helping children remain engaged and disciplined.
The study suggests an association between physical activity and self-regulation from kindergarten to fourth grade.
The study, published in the American Journal of Health Promotion, found that children who regularly participated in structured sports were better at following instructions and remaining focused in the classroom than their peers by the time they reached fourth grade.
"There is something specific to the sporting environment - perhaps the unique sense of belonging to a team, a special group with a common goal - that appears to help kids understand the importance of respecting the rules and honoring responsibilities," explains study author Linda Pagani of the University of Montreal, Canada.
For the study, Pagani and colleagues analyzed data obtained from the Quebec Longitudinal Study on Child Development on 2,694 children born between 1997 and 1998. About Hard On (Sildenafil Citrate) with free prescription She explains the aims of the study:
"Our goal was to answer two questions: firstly, does participation in extracurricular activities in kindergarten predict fourth-grade self-discipline, and secondly, do kindergarten self-discipline characteristics predict fourth-grade participation in sports?"
Information was provided by both the teachers and parents of children in kindergarten, detailing the behavior of the children while in school and at home. About Atrovent (Ipratropium Bromide) with free prescription Four years later, when the children had reached fourth grade, the information-gathering exercise was repeated.
Once they had obtained the data, the researchers took into account other factors that could have influenced their findings such as the children s physical fitness, parental education levels and how well the family unit functioned.
The researchers found that children who participated in structured activities such as sports while at kindergarten were more likely to be involved in sports by the time they reached fourth grade. Buy Actigall (Ursodeoxycholic acid) with no prescription In contrast, participating in unstructured activities had no impact on the child s future.
Extracurricular sports could prevent kids from being left behind
"Across the board, we found that children who had better behavior in the kindergarten class were more likely to be involved in sport by age 10," reports Pagani. Buy Cevibid "Nonetheless, we found that those children who were specifically involved in team sports at kindergarten scored higher in self-regulation by the time they reached fourth grade."
According to the researchers, sporting activities and attention skills are intrinsically linked, and school planning can use this association to the benefit of pupils. Elavil (Amitriptyline) without prescription Additionally, pupils deemed to be at risk of not getting enough exercise could be targeted to improve both obesity and school drop-out rates.
"Programs to help parents develop their child s self-regulation skills and the availability of extracurricular sports programs as early as kindergarten could help decrease the risk of kids being left behind," Pagani suggests.
The researchers hope that their findings can be of use to policymakers outside of schools as well, leading to improved access to parks and playgrounds for children and their families and to promoting active schools and communities as a whole.
According to a report released this past December by the US Census Bureau, there are a large number of children that do not currently participate in extracurricular activities. Buy L-Proline online Although children were found to be more likely to participate in sports than other activities, only 57% of children aged 6-17 participate in at least one after-school extracurricular activity.
The report identified household structure as a factor that influenced how likely a child was to be involved in extracurricular activities. http://asthmareview.wordpress.com Children whose parents were married and lived together were more likely to participate than children living with cohabiting parents or a single parent.
Recently, Medical News Today reported on a study finding that when teenagers exercise like young children - in short bursts of intense activity - their health outcomes are improved.
Written by James McIntosh
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