BEERSE, Belgium--(BUSINESS WIRE)--Data from the investigational, randomised, multi-centre, open-label
Phase 3 RESONATETM-2 (PCYC-1115) trial show ibrutinib
(IMBRUVICA®) was superior to chlorambucil in all efficacy
endpoints measured in patients with treatment-na"ive chronic lymphocytic
leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older,
Janssen-Cilag International NV announced today. Kamagra (Sildenafil Citrate) without prescription Ibrutinib significantly
prolonged progression-free survival (PFS), the study’s primary endpoint,
and overall survival (OS), a key secondary endpoint, and also improved
other haematologic measures. Buy Neggram (Nalidixic Acid) with no prescription Notably, ibrutinib was associated with a 98
percent OS rate versus 85 percent for chlorambucil at 24 months. Proventil (Albuterol) without prescription These
data will be included in a presentation today during the official press
programme at the 2015 American Society of Hematology (ASH) meeting in
Orlando, FL, U.S. Buy Infiniair with free prescription and simultaneously published in The New England
Journal of Medicine.1 IMBRUVICA is co-developed by Cilag
GmbH International, a member of the Janssen Pharmaceutical Companies,
and Pharmacyclics LLC, an AbbVie company. Caverta (Sildenafil Citrate) with no prescription Janssen affiliates market
IMBRUVICA in EMEA (Europe, Middle East and Africa) as well as the rest
of the world, except for the United States, where Janssen Biotech, Inc. Buy Histidine online
and Pharmacyclics LLC co-market it.
These data will be presented in full by RESONATE-2 study investigator
Alessandra Tedeschi, M.D., Medical Director, Azienda Ospedaliera
Niguarda Ca Granda, Milan, Italy, during the “CLL: Therapy, Excluding
Transplantation: Upfront CLL Therapy Excluding Transplantation” session
on Monday, December 7, at 7:30am Eastern Time (ET) / 1.30pm Central
European Time (CET).
"The RESONATE-2 trial is ground-breaking as the first randomised Phase 3
trial of B-cell receptor antagonist, ibrutinib, in previously untreated
CLL,” said Professor Peter Hillmen, Haematology, St. http://doctor-consult.blogspot.com James’s University
Hospital, Leeds, who is an investigator in the RESONATE-2 clinical
trial. “The results of RESONATE-2 are impressive. The improvement in
progression free survival for ibrutinib in front-line treatment compared
to chlorambucil is statistically significant. The improvement in overall
survival for ibrutinib compared to chlorambucil even with a pre-planned
cross-over to ibrutinib is unexpected. This indicates that the best
outcomes will be achieved with ibrutinib when it is used as the initial
therapy in patients with CLL."
The Independent Review Committee (IRC) found ibrutinib significantly
prolonged PFS compared with chlorambucil. The hazard ratio (HR) was 0.16
(95 percent CI, 0.09-0.28; P<0.001), which represents a reduction in the
risk of progression or death by 84 percent versus chlorambucil (median
not reached vs. 18.9 months); the PFS rate at 18 months was 90 percent
for ibrutinib versus 52 percent for chlorambucil. Ibrutinib also
significantly prolonged OS (HR=0.16: 95 percent CI, 0.05, 0.56; P=0.001)
with a 24-month survival rate of 98 percent, compared to 85 percent for
patients in the chlorambucil arm. Additionally, ibrutinib was associated
with a significantly higher ORR (86 percent vs. 35 percent; P<0.001) as
assessed by the IRC and significantly increased the rate of sustained
improvements in both haemoglobin and platelets.1
“RESONATE-2 is the first Phase 3 head-to-head trial to evaluate the
efficacy and safety of ibrutinib monotherapy versus traditional
chemotherapy in patients with treatment-na"ive CLL. The strength of these
data may very well represent a turning point in the treatment of CLL/SLL
and change when it may be appropriate to treat these patients with
ibrutinib,” said Jane Griffiths, Company Group Chairman, Janssen Europe,
Middle East and Africa. “We continue to see positive results with
ibrutinib, and it is particularly exciting to see the extent of new data
at ASH, demonstrating our commitment to exploring ibrutinib use for
those who could most benefit from it, and our growing haematology
offering.”
The safety of ibrutinib in this patient population was consistent with
previously reported studies. It is worth noting that exposure to
treatment and adverse event (AE) follow-up was nearly 2.5 times longer
for ibrutinib compared with chlorambucil and 87 percent of patients
randomised to ibrutinib were still on therapy at the time of analysis.
Overall, AEs leading to treatment discontinuation were less frequent
with ibrutinib than with chlorambucil (nine percent vs. 23 percent,
respectively). The most common AEs (>=20 percent) of any Grade in the
RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30
percent), cough (22 percent) and nausea (22 percent); AEs for
chlorambucil included nausea (39 percent), fatigue (38 percent),
neutropenia (23 percent) and vomiting (20 percent). Hypertension
occurred at a higher rate in the ibrutinib arm (14 percent; Grade 3 in
four percent, no Grade 4 or 5). All six patients with Grade 3
hypertension were managed with hypertensive medication and did not
require ibrutinib dose reduction or discontinuation. Four ibrutinib
patients experienced Grade 3 haemorrhage and one experienced Grade 4
haemorrhage.1 Atrial fibrillation occurred in
eight patients (six percent) in the ibrutinib arm and was primarily
Grade 2 in six patients and Grade 3 in two patients. It was managed with
discontinuation in two patients and without a dose modification in
remaining patients.
There were three deaths in the ibrutinib arm and 17 deaths on the
chlorambucil arm over the median follow-up of 18.4 months. None of the
patients who progressed on the ibrutinib arm died during the subsequent
follow-up period.1
RESONATE-2 is a Pharmacyclics-sponsored trial and is the second Phase 3
study demonstrating a significant benefit of ibrutinib vs. a comparator.2,3
The trial enrolled 269 patients with CLL/SLL aged 65 years or older
without prior treatment in the U.S., EU and other regions. CLL patients
with deletion of the short arm of chromosome 17 (del 17p CLL) were
excluded from the trial as single-agent chlorambucil is not recognised
as an appropriate therapy in this patient population. Patients were
randomised to receive either ibrutinib 420 mg orally, once daily until
progression or toxicity or chlorambucil 0.5 to 0.8 mg/kg on days one and
15 of each 28-day cycle for up to 12 cycles. The primary endpoint of the
study was PFS as assessed by an IRC according to the International
Workshop on Chronic Lymphocytic Leukaemia (iWCLL) 2008 criteria, with
modification for treatment-related lymphocytosis. Key secondary
endpoints included ORR, OS, rate of haematologic improvement and safety.1
The RESONATE-2 results are the basis for a Type II variation application
to the European Medicines Agency (EMA), seeking to broaden the existing
marketing authorisation for IMBRUVICA to include previously untreated
patients with CLL, which was which was announced on November
3, 2015. More information about the study can be found on .clinicaltrials.gov.
About IMBRUVICA® (ibrutinib)
Ibrutinib is a first-in-class Bruton s tyrosine kinase (BTK) inhibitor,
which works by forming a strong covalent bond with BTK to block the
transmission of cell survival signals within the malignant B cells.4
By blocking this BTK protein, ibrutinib helps kill and reduce the number
of cancer cells. It also slows down the worsening of the cancer.5
Ibrutinib is approved in Europe for the treatment of adult patients with
relapsed or refractory mantle cell lymphoma (MCL), or adult patients
with chronic lymphocytic leukaemia (CLL) who have received at least one
prior therapy, or in first line patients with CLL in the presence of 17p
deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy;6
it is also approved for adult patients with Waldenstr"om’s
macroglobulinemia (WM) who have received at least one prior therapy, or
in first line treatment for patients unsuitable for chemo-immunotherapy;6
regulatory approval for additional uses has not yet been
granted. Investigational uses for ibrutinib, alone and in combination
with other treatments, are under way in several blood cancers including
CLL, MCL, WM, diffuse large B-cell lymphoma (DLBCL), follicular lymphoma
(FL), multiple myeloma (MM) and marginal zone lymphoma (MZL).
Ibrutinib is co-developed by Cilag GmbH International, a member of the
Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie
company. Janssen affiliates market ibrutinib in EMEA (Europe, Middle
East and Africa) as well as the rest of the world, except for the United
States, where Janssen Biotech, Inc. and Pharmacyclics LLC co-market it.
Janssen and Pharmacyclics are continuing an extensive clinical
development programme for ibrutinib, including Phase 3 study commitments
in multiple patient populations – please see the IMBRUVICA
summary of product characteristics for further information.
About CLL
In most patients, CLL is generally a slow-growing blood cancer of the
white blood cells called B-lymphocytes.7 The median age at
diagnosis is 72 years,8 and incidence rates among men and
women in Europe are approximately 5.87 and 4.01 cases per 100,000
persons per year, respectively.9 CLL is a chronic disease;
median overall survival ranges between 18 months and more than 10 years
according to the stage of disease.10 The disease eventually
progresses in the majority of patients, and patients are faced with
fewer treatment options each time. Patients are often prescribed
multiple lines of therapy as they relapse or become resistant to
treatments.
CLL cells are found in both the lymphatic system and the blood.11
When the cancer cells are located mostly in the lymph nodes, the disease
is called small lymphocytic lymphoma (SLL). Both CLL and SLL are
considered different manifestations of the same entity, as classified in
the fourth edition of the World Health Organization Classification of
Tumours of Haematopoietic and Lymphoid Tissues.12
Janssen in Oncology
Our goal is to fundamentally alter the way cancer is understood,
diagnosed, and managed, reinforcing our commitment to the patients who
inspire us. In looking to find innovative ways to address the cancer
challenge, our primary efforts focus on several treatment and prevention
solutions. These include a focus on haematologic malignancies, prostate
cancer and lung cancer; cancer interception with the goal of developing
products that interrupt the carcinogenic process; biomarkers that may
help guide targeted, individualised use of our therapies; as well as
safe and effective identification and treatment of early changes in the
tumour microenvironment.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to
addressing and solving the most important unmet medical needs of our
time, including oncology (e.g., multiple myeloma and prostate cancer),
immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia,
dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and
tuberculosis), and cardiovascular and metabolic diseases (e.g.,
diabetes). Driven by our commitment to patients, we develop sustainable,
integrated healthcare solutions by working side-by-side with healthcare
stakeholders, based on partnerships of trust and transparency. More
information can be found on .janssen-emea.com.
Follow us on .twitter.com/janssenEMEA
for our latest news.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
product development. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of any of the Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in new product development,
including obtaining regulatory approvals; uncertainty of commercial
success; competition, including technological advances, new products and
patents attained by competitors; challenges to patents; product efficacy
or safety concerns resulting in product recalls or regulatory action;
changes in behaviour and spending patterns or financial distress of
purchasers of health care products and services; changes to applicable
laws and regulations, including global health care reforms;
manufacturing difficulties and delays; and trends toward health care
cost containment. A further list and description of these risks,
uncertainties and other factors can be found in Johnson & Johnson s
Annual Report on Form 10-K for the fiscal year ended December 28, 2014,
including in Exhibit 99 thereto, and the company s subsequent filings
with the Securities and Exchange Commission. Copies of these filings are
available online at .sec.gov,
.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertake to update any forward-looking
statement as a result of new information or future events or
developments.
References
1. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib vs
chlorambucil in treatment-na"ive chronic lymphocytic leukemia. N Engl
J Med. 2015:1-8.
2. Byrd JC, Brown JR, O’Brien S, et al. Ibrutinib versus
ofatumumab in previously treated chronic lymphoid leukemia. N Engl J
Med. 2014;371:213-23.
3. Brown JR, Hillmen P, O’Brien S, et al. Updated efficacy
including genetic and clinical subgroup analysis and overall safety in
the phase 3 RESONATE™ trial of ibrutinib versus ofatumumab in previously
treated chronic lymphocytic leukemia/small lymphocytic lymphoma. Blood.
2014;124(21):abstract 3331.
4. O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial
therapy for elderly patients with chronic lymphocytic leukaemia or small
lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet
Oncol. 2014;15:48-58.
5. European Medicines Agency. How is the medicine expected to work? .ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/06/human_orphan_001058.jsp&mid=WC0b01ac058001d12b
Last accessed November 2015.
6. Imbruvica Summary of Product Characteristics, October 2015. Available
at: .ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf
Last accessed November 2015.
7. American Cancer Society. What is chronic lymphocytic leukemia?
Available at: .cancer.org/cancer/leukemia-chroniclymphocyticcll/detailedguide/leukemia-chronic-lymphocytic-what-is-cll
Last accessed November 2015.
8. Eichhorst B, Dreyling M, Robak T, Montserrat E, Hallek M; ESMO
Guidelines Working Group. Chronic lymphocytic leukemia: ESMO Clinical
Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol
2011;22(Suppl.6):vi50-vi54.
9. Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic
malignancies in Europe by morphologic subtype: results of the HAEMACARE
project. Blood 2010;116:3724-34.
10. Sagatys EM, Zhang L. Clinical and laboratory prognostic indicators
in chronic lymphocytic leukemia. Cancer Control
2012;19:18-25.Stilgenbauer S, Zenz T. Understanding and Managing Ultra
High-Risk Chronic Lymphocytic Leukemia. Hematology. 2010;481-8.
11. Hallek M. Signaling the end of chronic lymphocytic leukemia: new
frontline. Blood. 2013;122:3723-34.
12. Santos FP, O’Brien S. Small lymphocytic lymphoma and chronic
lymphocytic leukemia are they the same disease? Cancer J.
2012;8:396-403.
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24 October 2015
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration’s
(FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the
approval of lesinurad 200 mg tablets for the treatment of hyperuricemia
associated with gout, in combination with a xanthine oxidase inhibitor
(XOI). About Depakote (Divalproex) without prescription The AAC reviewed safety and efficacy data from the pivotal Phase
III combination therapy program trials, representing the largest
clinical trial data set of gout patients treated with combination urate
lowering therapy.
The FDA is not bound by the Advisory Committee’s recommendation but
takes its advice into consideration when reviewing the application for a
potential medicine. About Rogaine (Minoxidil) with no Rx The Prescription Drug User Fee Act (PDUFA) target
goal date for lesinurad is December 29, 2015.
If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. About Astelin (Azelastine) without Rx It inhibits the urate
transporter, URAT1, which is responsible for the majority of the renal
reabsorption of uric acid.
Sean Bohen, Executive Vice President of Global Medicines Development and
Chief Medical Officer, AstraZeneca, said: “The Committee’s positive
recommendation for lesinurad is an encouraging step for patients
suffering from the debilitating effects of gout, a disease in which
there has been limited treatment innovation over the last 50 years. About Griseofulvin with free prescription We
look forward to the outcome of the FDA’s review and the opportunity to
provide a new treatment option that when combined with an XOI addresses
both the under-excretion and over-production of uric acid, the
underlying causes of gout.”
Gout is a serious and debilitating form of inflammatory arthritis caused
by hyperuricemia (elevated serum uric acid (sUA)). Buy Dilantin (Phenytoin) with free prescription Gout affects millions
of Americans, many of whom do not reach recommended sUA treatment goals
on the current standard of care (XOIs), which decrease production of
uric acid. Buy Food Based Calcium and Magnesium online For those inadequately controlled patients, the addition of a
urate lowering therapy to increase excretion of uric acid, may help them
achieve treatment goals.
Lesinurad is also under regulatory review in the European Union and
other territories.
NOTES TO EDITORS
About Lesinurad
If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. http://webmd-help.blogspot.com It inhibits the urate
transporter, URAT1, which is responsible for the majority of the renal
reabsorption of uric acid. By inhibiting URAT1, lesinurad increases uric
acid excretion and thereby lowers serum uric acid (sUA). Lesinurad also
inhibits organic anion transporter (OAT4) a uric acid transporter
involved in diuretic-induced hyperuricemia. In addition, in patients,
lesinurad does not inhibit OAT1 and OAT3, which are drug transporters in
the kidney associated with drug-drug interactions.
If approved, lesinurad in combination with an XOI would provide a dual
mechanism of action to increase excretion and decrease production of
uric acid enabling more patients with inadequately controlled gout to
achieve target treatment goals.
About Hyperuricemia and Gout
Gout is a serious, chronic, progressive, and debilitating form of
inflammatory arthritis. Currently, there are more than 8.3 million
patients suffering from gout in the US. The underlying cause of gout is
hyperuricemia (elevated serum uric acid (sUA)), which leads to the
deposition of crystals primarily in the joints and in other tissues.
This can result in recurrent attacks of inflammatory arthritis and, if
left uncontrolled, could lead to chronic, progressive arthritis, and
tophus (visible deposits of urate crystals) formation.
The goal of sUA lowering treatment is to reduce sUA levels tothe target
level of <6.0 mg/dL as recommended by the American College of
Rheumatology (ACR). To improve signs and symptoms such as tophaceous
gout, the ACR guidelines state that achieving and maintaining sUA levels
<5.0 mg/dL may be required.
Among patients treated in clinical trials, less than 50% of patients on
allopurinol 300 mg reached serum uric acid (sUA) target levels <6.0
mg/dL. This suggests approximately two million gout patients in the US
on urate lowering therapy remain inadequately controlled. For patients
who cannot reach target on an XOI alone, the current ACR guidelines
recommend adding an agent that increases uric acid excretion.
About Ardea Biosciences
Ardea Biosciences, Inc. was acquired by AstraZeneca in June 2012. It is
located in San Diego, California and is a member of the AstraZeneca
Group. Ardea is leading the development of AstraZeneca’s gout portfolio,
including lesinurad and RDEA3170. RDEA3170 is a potent selective uric
acid reabsorption inhibitor (SURI), also intended for use as a
combination urate lowering therapy with xanthine oxidase inhibitors
(XOIs). RDEA3170 is our lead investigational urate lowering therapy
(ULT) in Asia and is currently entering a Phase IIb trial in the US.
About AstraZeneca
AstraZeneca (NYSE: AZN) is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the treatment
of cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates in
over 100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit: .astrazeneca-us.com.
3176137 10/15
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ELLENTON, Fl orida--(BUSINESS WIRE)--A fam ilia Feld, propriet aria da Feld Entertainment, Inc. Buy Cellcept (Mycophenolate Mofetil) with no Rx – empresa
matriz do Ringling Bros. About Temovate (Clobetasol) without Rx and Barnum & Bailey®
e do Ringling Bros. About Exelon (Rivastigmine Tartrate) Center for Elephant Conservation®
–, anunciou ontem um novo esforco de financiamento com o Intermountain
Primary Children’s Hospital (PCH), com oncologistas do Departamento de
Pediatria da Universidade de Utah e com o Dr. Genpril with free Rx Joshua Schiffman do
Huntsman Cancer Institute. Buy Evecare () without prescription O compromisso de captac~ao de recursos vem na
sequ^encia de novas descobertas de uma pesquisa sobre c^ancer publicada
pelo Dr. Buy Erectile Dysfunction online Schiffman no Journal of American Medical Association (JAMA), o
peri odico cient ifico da Associac~ao M edica Americana.
A Feld Entertainment lancou hoje um pacote de v ideo de acompanhamento
que descreve a pesquisa. http://webmd-review.blogspot.com O v ideo pode ser visto aqui.
Dr. Schiffman e a equipe do Primary Children’s Hospital, do Departamento
de Pediatria e do Huntsman Cancer Institute – todos situados em Salt
Lake City, Utah – est~ao estudando por que h a uma incid^encia t~ao baixa de
c^ancer em elefantes, o que torna poss ivel essa resist^encia `a doenca
entre elefantes e n~ao em seres humanos, e como isso pode se
correlacionar com novos tratamentos de c^ancer pedi atrico.
Mais de 16 mil criancas e adolescentes s~ao diagnosticados com c^ancer
todos os anos nos Estados Unidos, enquanto entre elefantes, praticamente
n~ao h a incid^encia da doenca ao longo de toda a vida do animal. Dr.
Schiffman; Dr. Dennis Schmitt, chefe de Servicos Veterin arios e diretor
de Pesquisa do Ringling Bros. and Barnum & Bailey; e Dr.
Wendy Kiso, cientista de Pesquisa e Conservac~ao do Ringling Bros.
Center for Elephant Conservation; entre outros colaboradores
cientistas em suas equipes, confirmaram recentemente que os elefantes
raramente desenvolvem c^ancer, com uma taxa de mortalidade inferior a 5%.
Para efeito de comparac~ao, a mesma taxa entre humanos e de 25%. Ao
estudarem o genoma dos elefantes, eles descreveram que esses animais
possuem 40 c opias de um gene supressor de tumor chamado TP53,
enquanto os seres humanos t^em somente duas c opias.
Trabalhando com o Jardim Zool ogico Hogle de Utah e o Ringling Bros.
Center for Elephant Conservation, Dr. Schiffman e seus colegas
estudaram a reac~ao do sangue de elefantes a agentes de danificac~ao de
DNA e descobriram que a c elula do animal sofre morte celular mais
rapidamente quando comparada com as celulas humanas. Dr. Schiffman
acredita que pode ser por isso que os elefantes desenvolvem menos c^ancer
do que os seres humanos. As descobertas completas do estudo foram
publicadas na nova edic~ao do Journal
of American Medical Association.
A aplicac~ao de pesquisa translacional sobre o c^ancer – as descobertas
provenientes da ci^encia b asica que melhoram a sa ude e o bem-estar
humanos aperfeicoando pr aticas m edicas e de enfermagem, e criando
resultados de sa ude significativos – poderia pavimentar o caminho rumo a
uma fronteira inteiramente nova para a pesquisa e o tratamento do
c^ancer, da mesa do laborat orio ao leito do paciente.
A fam ilia Feld est a formando o Ringling Bros. Children’s Fund™
como um elemento de sua filantropia cont inua atrav es da Feld Family
Foundation para apoiar iniciativas beneficentes para as criancas. Como
parte da parceria com o Primary Children’s Hospital, o Departamento de
Pediatria e Dr. Schiffman, o Ringling Bros. Children’s Fund e
o Ringling Bros. and Barnum & Bailey ir~ao doar mais de
US$ 1 milh~ao em apoio `a pesquisa sobre o c^ancer e ao atendimento de
criancas.
Nas pr oximas 50 cidades visitadas pelo Ringling Bros. and Barnum
& Bailey , a Ringling Bros. ir a doar US$ 10 mil a um
hospital infantil ou centro de tratamento local, e o Ringling
Bros. Children’s Fund ir a equiparar cada doac~ao com uma doac~ao
adicional de US$ 10 mil `a Primary Children’s Hospital Foundation em
apoio a seu Programa de Pesquisa sobre o C^ancer Pedi atrico. Esse
programa, que ajudou a apoiar a pesquisa com elefantes, concentra-se em
novas abordagens de prevenc~ao e diagn ostico, e na melhoria do valor do
tratamento contra o c^ancer pedi atrico.
Informac~oes adicionais sobre o Ringling Bros. and Barnum & Bailey
e o Ringling Bros. Center for Elephant Conservation, a parceria e
tamb em sobre como as fam ilias podem fazer doac~oes `a pesquisa podem ser
encontradas na internet em .ringling.com
e .ringlingelephantcenter.com.
NOTA DO EDITOR: Informac~oes
complementares para apoiar a reportagem est~ao anexas e podem ser
encontradas tamb em aqui.
Sobre a Feld Entertainment
A Feld Entertainment e a l ider mundial em turn^es de produc~ao e
apresentac~ao ao vivo, dedicadas a experi^encias de entretenimento
familiar que eleva o esp irito humano e cria mem orias inesquec iveis, com
30 milh~oes de espectadores em suas apresentac~oes a cada ano. As
produc~oes da Feld Entertainment j a estiveram at e hoje em mais de
75 pa ises e nos seis continentes e incluem Ringling Bros. and
Barnum & Bailey®, Monster Jam®,
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Ice apresentada por Stonyfield YoKids Organic Yogurt, Disney Live!
Apresentada por Stonyfield YoKids Organic Yogurt e Marvel Universe LIVE!
Mais informac~oes sobre a Feld Entertainment podem ser encontradas em .feldentertainment.com.
Mais informac~oes sobre o Ringling Bros. Center for Elephant
Conservation est~ao dispon iveis em .ringlingelephantcenter.com.
Sobre o Primary Children’s Hospital
O Primary Children s Hospital e o unico hospital infantil de servicos
integrais para Utah, Idaho, Wyoming, Nevada e Montana, prestando
atendimento a criancas com as mais complexas les~oes e enfermidades,
incluindo as que necessitam de transplante de corac~ao, f igado, rim e
medula ossea. O Primary Children’s e o unico Centro de Trauma Pedi atrico
de N ivel 1 na regi~ao Intermountain West. O hospital e de propriedade da
Intermountain Healthcare, um sistema de assist^encia `a sa ude sem fins
lucrativos, e e afiliado `a Escola de Medicina da Universidade de Utah,
que re une pesquisa, treinamento e tratamento de excel^encia para oferecer
a melhor assist^encia `a sa ude para as criancas. As doac~oes s~ao
administradas pela Primary Children’s Hospital Foundation, uma
instituic~ao beneficente incorporada separadamente sob o c odigo IRS
501(c)(3). A fundac~ao apoia as metas do hospital de oferecer assist^encia
pedi atrica do mais alto n ivel em uma atmosfera de amor e cuidado.
Sobre o Departamento de Pediatria da Universidade de Utah
O Departamento de Pediatria e o segundo maior departamento da Escola de
Medicina da Universidade de Utah e um dos maiores departamentos
pedi atricos dos EUA. Ele possui mais de 270 membros docentes, com uma
distribuic~ao equitativa entre homens e mulheres, e tem o maior n umero de
docentes titulares mulheres da Escola de Medicina. O departamento e
composto de 22 divis~oes m edicas e programas, que operam em conjunto com
quatro iniciativas principais: educac~ao, pesquisa, cl inica e acad^emica.
Suas divis~oes fornecem um conjunto completo de especialidades e
subespecialidades de servicos pedi atricos para criancas de toda a regi~ao
de Intermountain West.
Sobre o Huntsman Cancer Institute da Universidade de Utah
O Huntsman Cancer Institute (HCI) e um dos maiores centros de pesquisa
acad^emica e tratamento de c^ancer do mundo. O HCI gerencia o Banco
de Dados da Populac~ao de Utah , a maior base de dados gen etica do
mundo, com mais de 16 milh~oes de registros vinculados a genealogias,
registros de sa ude e estat isticas vitais. Utilizando esses dados, os
pesquisadores do HCI j a identificaram v arios genes causadores de c^ancer,
incluindo aqueles respons aveis por melanoma, c^ancer de colo do utero,
c^ancer de mama e paraganglioma. O instituto e membro da National
Comprehensive Cancer Network (uma alianca composta de 26 centros de
c^ancer l ideres mundiais) e e um National
Cancer Institute-Designated Comprehensive Cancer Center. O HCI trata
pacientes com todas as formas de c^ancer e opera diversas cl inicas de
alto risco dedicadas ao c^anceres de pele, mama, colo do utero e
p^ancreas. O Centro de Aprendizagem sobre o C^ancer do HCI, voltado `a
formac~ao de pacientes e do p ublico em geral, cont em um dos maiores
acervos de publicac~oes sobre c^ancer dos EUA. O nome do instituto e uma
homenagem a Jon
M. Huntsman, um filantropo, industrial e sobrevivente do c^ancer de
Utah.
O texto no idioma original deste an uncio e a vers~ao oficial autorizada.
As traduc~oes s~ao fornecidas apenas como uma facilidade e devem se
referir ao texto no idioma original, que e a unica vers~ao do texto que
tem efeito legal.
05 October 2015
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26 September 2015
KENILWORTH, N.J.--(BUSINESS WIRE)--MSD, known as Merck (NYSE:MRK) in the United States and Canada, today
announced the first-time presentation of findings investigating the use
of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1
therapy, as a monotherapy in patients with advanced unresectable
nasopharyngeal carcinoma (NPC) – a type of head and neck cancer – whose
tumors express PD-L1 (>=1% of cells in tumor nests or PD-L1+ bands in
stroma). Actoplus Met (Metformin And Pioglitazone) with no prescription Data were from a Phase 1b study (KEYNOTE-028) and showed an
overall response rate (ORR) (confirmed and unconfirmed) of 22.2 percent
(95% CI, 8.6-42.3) in evaluable patients (n=27) who were treated with
KEYTRUDA. Zocor (Simvastatin) with free prescription Results were presented in an oral session by Dr. Cialis Strong Pack-30 () without prescription Chiun Hsu,
National Taiwan University Hospital, at the European Cancer Congress
(ECC) in Vienna (Abstract #2801).
“Advanced nasopharyngeal carcinoma is a severe form of head and neck
cancer often associated with a poor prognosis,” said Dr. About Fluoromethalone without Rx Hsu. Kamagra Effervescent (Sildenafil Citrate) “These
data presented at ECC represent the potential for new approaches to
treat this type of cancer, for which there are currently limited
treatment options, and further support the need for additional research
into how KEYTRUDA may work for certain types of head and neck cancer.”
MSD has initiated a comprehensive clinical development program
evaluating KEYTRUDA in head and neck cancer across multiple lines of
therapy as monotherapy and in combination with chemotherapy as well as
other agents. Buy Cold Formulas online In KEYNOTE-028, KEYTRUDA is being evaluated in patients
with advanced unresectable NPC that is not responding to current therapy
or for which current therapy is not appropriate. http://webmd-consult.blogspot.com This is the second
study to show early activity of KEYTRUDA in patients with head and neck
cancer and the first study of an anti-PD-1 therapy to demonstrate
clinical activity in patients with recurrent or metastatic NPC. For more
information about our oncology clinical trials, visit .keynoteclinicaltrials.com.
“The findings emerging from this trial again demonstrate that KEYTRUDA
is active across a broad range of cancers, including those that are
difficult to treat with standard treatments,” said Dr. Roger Dansey,
senior vice president and therapeutic area head, oncology late-stage
development, Merck Research Laboratories. “Based on these and other
results to date, we are continuing to advance a comprehensive head and
neck clinical program for KEYTRUDA, and we remain focused on realizing
its full potential to address the unmet treatment needs for patients
with difficult-to-treat cancers such as nasopharyngeal carcinoma.”
Additional Nasopharyngeal Carcinoma Results from KEYNOTE-028
KEYNOTE-028 is an ongoing multi-cohort, non-randomized Phase 1b basket
trial (a trial design that allows for the study of multiple
sub-populations of different tumor or histological types within one
study) evaluating the safety, tolerability, and anti-tumor activity of
KEYTRUDA monotherapy (10 mg/kg dosed every two weeks) in more than 450
patients across 20 different types of cancer. The study was designed to
evaluate patients with advanced solid tumors that express PD-L1 and
which have not responded to current therapy or for which current therapy
is not appropriate.
These early findings from 27 heavily pre-treated patients with advanced
NPC demonstrated an ORR of 22.2 percent (n=6/27) (per RECIST v1.1),
including six partial responses (95% CI, 8.6-42.3). Additionally, 55.6
percent of patients had stable disease (n=15/27) (95% CI, 35.3-74.5),
the disease control rate (DCR) was 77.8 percent (n=21/27) (95% CI,
57.7-91.4), and tumor shrinkage was achieved in 67 percent of patients.
The 6-month progression-free survival (PFS) rate was 49.7 percent and
the 12-month PFS rate was 28.9 percent. The median follow-up duration
for evaluable patients was 12.9 months (range, 2.2-15.0) and the median
response duration was 10.8 months (range, 4.8- 10.8).
Adverse events were generally consistent with previously reported safety
data for KEYTRUDA. Grade 3-5 investigator-assessed, treatment-related
adverse events were hepatitis (n=2), pneumonitis (n=2), anemia (n=1),
facial pain (n=1), increased blood creatine phosphokinase (n=1),
proteinuria (n=1), and sepsis (n=1). Immune-mediated adverse events were
hypothyroidism (n=5), hepatitis (n=4), and pneumonitis (n=3). There was
one treatment-related death due to bacterial sepsis.
About PD-L1 and PD-L1 Expression
PD-L1, also called programmed death-ligand 1, is a protein expressed on
many types of cells, including some cancer cells. Under normal
conditions, the interaction of PD-L1 with another protein, called
programmed death receptor-1 (PD-1), serves as an important immune system
checkpoint, keeping the immune system in balance and preventing the body
from attacking its own cells when inflammation or an infection is
present. When cancerous tumors express PD-L1, however, they are able to
escape detection and destruction by cytotoxic T-cells – a type of
cancer-killing immune cell – allowing the tumor to survive and grow.
Tumor PD-L1 expression has been observed at varying levels across many
tumor types, including breast, lung, bladder cancer, and nasopharyngeal
carcinoma. High levels of PD-L1 expression, called overexpression, are
under investigation for potential use as a way to help identify patients
with an enhanced likelihood to respond to certain immune-based treatment
approaches.
About Nasopharyngeal Cancer
Nasopharyngeal cancer (NPC) is a type of head and neck cancer that
starts in the epithelial cells that line the surface of the nasopharynx,
the upper part of the throat behind the nose and near the base of skull.1
There are three types of NPC, based on how the cancer cells look under
the microscope: keratinizing squamous cell carcinoma, non-keratinizing
differentiated carcinoma, and undifferentiated carcinoma.1
Leading risk factors for NPC include Chinese or Asian ancestry, being
exposed to the Epstein-Barr virus, and drinking large amounts of alcohol.2
In most parts of the world (including the United States), there is less
than one case of NPC for every 100,000 people each year.3 In
2015, about 3,200 cases of NPC are expected to occur in the United
States.3
About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction
between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1
receptor and blocking the interaction with the receptor ligands,
KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune
response, including the anti-tumor immune response.
KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma and disease progression following ipilimumab and, if
BRAF V600 mutation positive, a BRAF inhibitor. This indication is
approved under accelerated approval based on tumor response rate and
durability of response. An improvement in survival or disease-related
symptoms has not yet been established. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials.
The KEYTRUDA clinical development program has rapidly expanded to
encompass more than 30 tumor types in more than 130 clinical trials, of
which more than 70 trials combine KEYTRUDA with other cancer treatments.
Registration-enabling trials of KEYTRUDA monotherapy are currently
enrolling patients in melanoma, NSCLC, head and neck cancer, bladder
cancer, gastric cancer, colorectal cancer, and Hodgkin Lymphoma, with
further trials in planning for other cancers.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or
3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving
KEYTRUDA. Monitor patients for signs and symptoms of pneumonitis.
Evaluate suspected pneumonitis with radiographic imaging. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA
for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4
pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of 411
patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving KEYTRUDA. Monitor patients for signs
and symptoms of colitis. Administer corticosteroids for Grade 2 or
greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently
discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411
patients, including a Grade 4 case in 1 (0.2%) patient, receiving
KEYTRUDA. Monitor patients for changes in liver function. Administer
corticosteroids for Grade 2 or greater hepatitis and, based on severity
of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2
case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving
KEYTRUDA. Monitor patients for signs and symptoms of hypophysitis
(including hypopituitarism and adrenal insufficiency). Administer
corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA
for Grade 2; withhold or discontinue for Grade 3; and permanently
discontinue KEYTRUDA for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2
or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving
KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients,
including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA.
Thyroid disorders can occur at any time during treatment. Monitor
patients for changes in thyroid function (at the start of treatment,
periodically during treatment, and as indicated based on clinical
evaluation) and for clinical signs and symptoms of thyroid disorders.
Administer corticosteroids for Grade 3 or greater hyperthyroidism.
Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for
Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with
replacement therapy without treatment interruption and without
corticosteroids.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred
in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and
other signs and symptoms of diabetes. Administer insulin for type 1
diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until
metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade
2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis
with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients
for changes in renal function. Administer corticosteroids for Grade 2 or
greater nephritis. Withhold KEYTRUDA for Grade 2; permanently
discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can occur.
The following clinically significant immune-mediated adverse reactions
occurred in patients treated with KEYTRUDA: exfoliative dermatitis,
uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial
seizures arising in a patient with inflammatory foci in brain
parenchyma, severe dermatitis including bullous pemphigoid, myasthenic
syndrome, optic neuritis, and rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on the
severity of the adverse reaction, withhold KEYTRUDA and administer
corticosteroids. Upon improvement of the adverse reaction to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at least
1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or
less. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
Infusion-related reactions, including severe and life-threatening
reactions, have occurred in patients receiving KEYTRUDA. Monitor
patients for signs and symptoms of infusion-related reactions including
rigors, chills, wheezing, pruritus, flushing, rashC hypotension,
hypoxemia, and fever. For severe or life-threatening reactions, stop
infusion and permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA may cause fetal harm when
administered to a pregnant woman. If used during pregnancy, or if the
patient becomes pregnant during treatment, apprise the patient of the
potential hazard to a fetus. Advise females of reproductive potential to
use highly effective contraception during treatment and for 4 months
after the last dose of KEYTRUDA.
KEYTRUDA was discontinued for adverse reactions in 9% of 411 patients.
Adverse reactions, reported in at least two patients, that led to
discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain.
Serious adverse reactions occurred in 36% of patients. The most frequent
serious adverse reactions, reported in 2% or more of patients, were
renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in at least 20% of patients)
were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash
(29%), decreased appetite (26%), constipation (21%), arthralgia (20%),
and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression or unacceptable toxicity. No formal pharmacokinetic drug
interaction studies have been conducted with KEYTRUDA. It is not known
whether KEYTRUDA is excreted in human milk. Because many drugs are
excreted in human milk, instruct women to discontinue nursing during
treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not
been established in pediatric patients.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology
medicines to help people with cancer worldwide. At MSD Oncology, helping
people fight cancer is our passion and supporting accessibility to our
cancer medicines is our commitment. Our focus is on pursuing research in
immuno-oncology and we are accelerating every step in the journey – from
lab to clinic – to potentially bring new hope to people with cancer. For
more information about our oncology clinical trials, visit .merck.com/clinicaltrials.
About MSD
Today’s MSD is a global healthcare leader working to help the world be
well. MSD is a tradename of Merck & Co., Inc., with headquarters in
Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines,
biologic therapies and animal health products, we work with customers
and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general
industry conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and healthcare legislation in the
United States and internationally; global trends toward healthcare cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of the company’s s
patents and other protections for innovative products; and the exposure
to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2014 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (.sec.gov).
References
1.
.cancer.org/cancer/nasopharyngealcancer/detailedguide/nasopharyngeal-cancer-what-is-nasopharyngeal-cancer
2.
.cancer.gov/types/head-and-neck/patient/nasopharyngeal-treatment-pdq
3.
.cancer.org/cancer/nasopharyngealcancer/detailedguide/nasopharyngeal-cancer-key-statistics
02 September 2015
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/xffzmh/drug_delivery_in)
has announced the addition of Jain PharmaBiotech s new report "Drug
Delivery in Central Nervous System Diseases - Technologies, Markets and
Companies" to their offering.
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drugs at the discovery stage to avoid development of drugs that fail to
reach their target site of action in the CNS.
Many of the new developments in the treatment of neurological disorders
will be biological therapies and these will require innovative methods
for delivery. About Estrace without Rx Cell, gene and antisense therapies are not only innovative
treatments for CNS disorders but also involve sophisticated delivery
methods. About Pamelor (Nortriptyline) RNA interference (RNAi) as a form of antisense therapy is also
described.
The role of drug delivery is depicted in the background of various
therapies for neurological diseases including drugs in development and
the role of special delivery preparations. Buy Body Lotion online Pain is included as it is
considered to be a neurological disorder. http://anti-infectives-opinion.blogspot.com A special chapter is devoted
to drug delivery for brain tumors. Cell and gene therapies will play an
important role in the treatment of neurological disorders in the future.
The method of delivery of a drug to the CNS has an impact on the drug s
commercial potential. The market for CNS drug delivery technologies is
directly linked to the CNS drug market. Values are calculated for the
total CNS market and the share of drug delivery technologies. Starting
with the market values for the year 2014, projections are made to the
years 2019 and 2024. The markets values are tabulated according to
therapeutic areas, technologies and geographical areas. Unmet needs for
further development in CNS drug delivery technologies are identified
according to the important methods of delivery of therapeutic substances
to the CNS. Finally suggestions are made for strategies to expand CNS
delivery markets. Besides development of new products, these include
application of innovative methods of delivery to older drugs to improve
their action and extend their patent life.
Profiles of 76 companies involved in drug delivery for CNS disorders are
presented along with their technologies, products and 80 collaborations.
These include pharmaceutical companies that develop CNS drugs and
biotechnology companies that provide technologies for drug delivery. A
number of cell and gene therapy companies with products in development
for CNS disorders are included. References contains over 420
publications that are cited in the report. The report is supplemented
with 51 tables and 12 figures.
Key Topics Covered:
Executive Summary
1. Basics of Drug Delivery to the Central Nervous System
2. Blood Brain Barrier
3. Methods of Drug Delivery to the CNS
4. Delivery of Cell, Gene and Antisense Therapies to the CNS
5. Drug Delivery for Treatment of Neurological Disorders
6. Drug delivery for brain tumors
7. Markets for Drug Delivery in CNS Disorders
8. Companies
9. References
For more information visit .researchandmarkets.com/research/xffzmh/drug_delivery_in
Source: Jain PharmaBiotech
28 August 2015
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/k7pp7t/analysis_of_the)
has announced the addition of the "Analysis
of the Immunochemistry Market in Malaysia" report to their
offering.
The Malaysian immunochemistry market is dominated by Roche, Siemens, and
Beckman Coulter. Buy Singulair (Montelukast) with no Rx Other participants are Becton Dickenson, Abbott,
Sysmex, and some Chinese companies. About Dilantin (Phenytoin) with free Rx The demand for immunochemistry tests
in tertiary care hospitals is high. Buy Minomycin (Minocycline) with free prescription Automated equipment is preferred but
some tier I and II hospitals operate on semi-automated chemistry
analyzers. Enalapril Public hospitals procure equipment using tenders, while
reagents are purchased in batches 2-3 times a year. Prometrium (Progesterone) The demand for
immunochemistry tests will grow, as communicable disease testing has
increased and preventive tests are common.
Key Topics Covered:
1. Buy Back Pain Relief online Executive Summary
- Scope and Segmentation
2. http://allergy-opinion.blogspot.com Key Trends
- Key Companies to Watch - Roche
- Key Companies to Watch - Axon Scientific
- Key Companies to Watch - BP Healthcare
- Key Companies to Watch - Snibe
3. Overview of the Malaysian Healthcare Market
- Overview of Healthcare Expenditure in Malaysia
- Overview of Population Forecast in Malaysia
- Growing Demand for and Affordability of Quality Healthcare Services
- Growth in Malaysian Hospitals
- Parallel Public and Private Healthcare Sectors in Malaysia
- Classification of Healthcare Services (HCS) in Malaysia
- Access to Public Secondary and Tertiary Service Care
- Principal Cause of Death in Public Hospitals
- Principal Cause of Death in Private Hospitals
4. Overview of the Malaysian Hospital Market and Trends in the
Immunochemistry Testing Market
- Malaysian Hospitals - Market Overview
- Category High Public Hospitals (>650 Beds per Hospital) - Key States
- Category Medium Public Hospitals (150-650 Beds) - Key States
- Category Low Public Hospitals (< 150 Beds) - Key States
- Malaysian IVD Market - Market Segmentation
- Customer Segmentation in the Malaysian Immunochemistry Market
- Segmentation of Key Immunochemistry Tests in Public Hospitals - Type
of Tests
- Top 3 Immunochemistry Tests in Demand in Malaysian Hospitals
- Usage Pattern of Immunochemistry Equipment
- In spite of prices of Healthcare services will get impacted due to
GST, the volume of test is unlikely to be effected
- Demand for Automated Immunochemistry Equipment Versus Conventional End
User s Perspective
- Procurement Process of Immunochemistry Equipment in Public Hospitals
- Procurement Process of Immunochemistry Equipment in Private Hospitals
and Diagnostic Laboratories
5. Competitor Playbook
- Overview of Key Competitors in the Immunochemistry Market in Malaysia
- Revenue Forecast
- Demand for Immunochemistry Equipment in Malaysia - A Distributor s
Perspective
- Top 3 Competitors - Manufacturers
- Segment Analysis of Competitors in the Immunochemistry Market
- Key Distributors in the Malaysian Immunochemistry Market
6. Opportunities, Drivers, and Restraints in the Malaysian
Immunochemistry Market
- Opportunity for Automated Equipment Manufacturers
- New Public Hospitals in Malaysia
- New Private Hospitals in Malaysia
- Key Market Drivers
- Key Market Restraints
7. Future Trends in the Malaysian Immunochemistry Market
For more information visit .researchandmarkets.com/research/k7pp7t/analysis_of_the
19 August 2015
Global Sports Medicine Market (by Segment) and Company Analysis to 2020
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/rwd7br/global_sports)
has announced the addition of the "Global
Sports Medicine Market (By Segment) and Company Analysis to 2020"
report to their offering.
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year and has a rosy future ahead. About Revia (Naltrexone) without Rx Sports medicine focuses on helping
people improve their athletic performance, recover from injury and
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people as well as athletes. About Tinidazole () with free Rx The major driving factors for the sports
medicine market are the aging population, increasing participation in
sports activities, technological advancements in the field of sports
medicine, rising awareness among athletes regarding physical and health
fitness and the increased incidence of sport related injuries to the
athletes and the long recovery periods involved as a cause of the
injury. About Elavil The lack of favorable reimbursement policies to the sport
related injuries and the high cost of sports medicine has been a major
challenge faced by the sports medicine market.
Global Sports Medicine Market Segment Wise Analysis: In the Global
sports medicine, Shoulder injuries accounts for the maximum share of the
market. Buy Retrovir (Zidovudine) The Knee injuries is the second leading segment in 2014 being
followed by Mechanical Resection. Buy Appetite Suppressant online Access stands at the fourth spot while
RF Resection is holding the fifth spot in the global sports medicine
market.
Global Sports Medicine Revenue Company Wise Analysis: Arthrex is the
global leader in the sports medicine market with Smith & Nephew in the
second position. http://asthmareview.wordpress.com DePuy Synthes Mitek holds the third spot in the global
sports medicine market. Stryker is the fourth leading player in global
sports medicine market in 2014. ConMed Linvatec and Biomet are competing
closely with each other in order to grab maximum share of the pie.
The Sports Medicine Market covered in the report is analyzed from 2
viewpoints follows:
1. Joint Repair - 3 Segments Covered
1. Hip
2. Knee
3. Shoulder
2. Arthroscopic Enabling Technologies - 5 Segments Covered
1. Video
2. Access
3. RF Resection
4. Mechanical Resection
5. Others
The 8 Companies analyzed in the reports are:
1. Arthrex
2. Arthrocare
3. Biomet (Acquired by Zimmer)
4. DePuy Mitek
5. ConMed Linvatec
6. Smith & Nephew
7. Stryker
8. Others
Key Topics Covered:
1. Executive Summary
2. Global Sports Medicine Market & Forecast (2012 - 2020)
3. Global Sports Medicine Market Share & Forecast - Segment Wise (2012 -
2020)
4. Global Sports Medicine Market Share & Forecast - Company Wise (2012 -
2020)
5. Global Sports Medicine Market & Forecast - Segment Wise (2012 - 2020)
6. Global Sports Medicine Revenue & Forecast - Company Wise (2012 - 2020)
7. Global Sports Medicine Market - Major Deals
8. Global Sports Medicine Market - Driving Factors
9. Global Sports Medicine Market - Challenges
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17 August 2015
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/qn2tn9/investigation)
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incidence of liver disease. Buy Norlutate (Norethindrone Acetate) with free prescription Viral hepatitis, fatty liver, alcoholic
liver disease, medicamentous liver lesion and liver cancer have posed a
severe threat to the Chinese people s health. Buy Janumet (Sitagliptin Metformin) with no prescription In recent years, drugs for
liver disease that rank second to proton pump inhibitor in drugs for the
digestive system have gradually become a variety with large sales value
which occupies 30% of the total sales value of all ten categories of
drugs for digestive system.
Among all the drugs for liver disease, polyene phosphatidyl choline is
the natural diglyceride of cholinephosphoric acid and unsaturated fatty
acids which can protect hepatocyte from lesion, alleviate inflammation
reaction and improve the detoxification of the liver. Ovral (Ethinyl estradiol / Norgestrel) with free Rx And it is used for
the treatment of hepatitis (acute and chronic), hepatic cirrhosis and
poisoning with certain efficacy in the clinic. Buy Dothiepin with free prescription First developed by
Sanofi, polyene phosphatidyl choline has been marketed under the trade
name of Essentiale Forte.
Some local enterprises are already capable of producing polyene
phosphatidyl choline APIs and injections. Sustiva (Efavirenz) with no Rx For example, Sichuan Haisco
Pharmaceutical Co., Ltd and Chengdu Tiantaishan Pharmaceutical Co., Ltd
have been approved to produce polyene phosphatidyl choline under the
trade name of Yibisheng. Buy Weight Gainers online Imported drugs mainly come from Sanofi
(Beijing), Shenzhen Sanofi Pasteur Biological Products Co., Ltd,
Sanofi-Aventis Ukraine LLc and A.Nattermann & Cie.GmbH.
The growth of polyene phosphatidyl choline has accelerated since 2006,
making it occupy an important proportion of the adjuvant drugs for liver
disease. http://medicalhelper.wordpress.com According to this survey, the sales value of polyene
phosphatidyl choline in sample hospitals rose from less than CNY 60
million in 2005 to over CNY 400 million in 2014 and CAGR during this
period reached 25%.
With the lifestyle changes brought about by economic development, the
incidence of liver disease in China has kept increasing. Therefore, the
market size of polyene phosphatidyl choline is expected to continue to
grow in the next few years in China.
Key Topics Covered:
1 Related Concepts of Polyene Phosphatidyl Choline
2 Market Profile of Polyene Phosphatidyl Choline in China
3 Survey on Sales Status of Polyene Phosphatidyl Choline in China,
2010-2014
4 Survey on Market Share of Major Manufacturers of Polyene Phosphatidyl
Choline in China, 2010-2014
5 Survey on Dosage Forms of Polyene Phosphatidyl Choline in China,
2010-2014
6 Reference Price of Polyene Phosphatidyl Choline in Chinese Hospitals
in 2014
7 Major Manufacturers of Polyene Phosphatidyl Choline in Chinese Market,
2010-2014
8 Market Outlook of Polyene Phosphatidyl Choline in China, 2015-2019
Companies Mentioned
- Shenzhen Sanofi Pasteur Biological Products Co., Ltd
- Hangzhou Sanofi-Synthelabo Minsheng Pharmaceutical Co., Ltd
- Chengdu Tiantaishan Pharmaceutical Co., Ltd
- Aventis Pharma S.p.A.
For more information visit .researchandmarkets.com/research/qn2tn9/investigation
27 July 2015
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/p8l4hh/global_colorectal)
has announced the addition of the "Global
Colorectal Cancer Drugs Market 2015-2019" report to their
offering.
The global colorectal cancer drugs market to grow at a CAGR of 3.62%
over the period 2014-2019.
Biologics are rapidly becoming the treatment of choice for colorectal
cancer. Buy Mobic (Meloxicam) without Rx Biologics are targeted therapy, which act only on the malignant
cells and do not attack the healthy cells. Buy Levaquin (Levofloxacin) with free prescription The major biologics used for
treating colorectal cancer include Erbitux (cetuximab), Zaltrap
(ziv-Aflibercept), Avastin (bevacizumab), and Vectibix (panitumumab). About Female Viagra (Sildenafil Citrate) with free prescription
These biologics together accounted for the major share of the market,
and the same trend is expected to continue during the forecast period.
According to the report, colorectal cancers cannot be cured by the
currently available therapeutic options. About Ditropan In addition, if it has not
metastasized, surgery would be the only option. About Thorazine (Chlorpromazine) without Rx The chances of cancer
recurring near the place of origin are high. Buy Vitamin B2 - Riboflavin online The currently available
branded and generic drugs are indicated only for off-label treatment
use. http://medical-reviews.blogspot.com However, these drugs have many side effects. Hyperbilirubinemia,
gastrointestinal perforation, coagulopathy, cardiotoxicity, hemorrhage,
hepatotoxicity, neutropenia, proteinuria, thrombocytopenia, ischemia,
soft tissue toxicity, pulmonary fibrosis, and increased mortality are
some of the significant adverse side effects. Thus, a drug maker has
opportunities to exploit and seek a favorable position in the market by
addressing these issues.
Further, the report states that many branded drugs available in the
market have lost their patents or are expected to lose it during the
forecast period.
This report covers the present scenario and the growth prospects of the
global colorectal cancer drugs market for the period 2015-2019. To
calculate the market size, the report considers revenue generated from
sales of various drugs used in the treatment of colorectal cancer.
Based on the type of molecule, the market is grouped into two
categories:
- Biologics
- Small molecules
Based on the route of administration, the market is grouped into two
categories:
- Oral
- Parenteral
Key Vendors
- Amgen
- Bayer
- Bristol-Myers Squibb
- F. Hoffmann-La Roche
- Merck Serono
Other Prominent Vendors
- Accord Healthcare
- Advenchen Laboratories
- Aeterna Zentaris
- AstraZeneca
- Bavarian Nordic
- Biothera
- Boehringer Ingelheim
- Daiichi Sankyo
- Debiopharm
- Eisai
- Eli Lilly
- Immodulon Therapeutics
- Mologen
- Mylan
- Nektar Therapeutics
- Oncothyreon
- Otsuka Pharmaceutical
- Precision Biologics
- Sun Pharmaceutical
- Symphogen
- Taiho
- Takeda
- Teva
- ThromboGenics
- Xbiotech
- Yakult Honsha
For more information visit .researchandmarkets.com/research/p8l4hh/global_colorectal
16 July 2015
Takeda pr'esente un dossier d'autorisation de mise sur le march'e pour l'ixazomib en vue du traitement des patients atteints de my'elome multiple r'ecurrent ou r'efractaire aux m'edicaments
CAMBRIDGE, Massachusetts et OSAKA, Japon--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (Bourse de Tokyo : 4502) a annonc e
aujourd hui qu elle avait pr esent e `a la Food and Drug Administration
(FDA) des Etats-Unis un dossier d autorisation de mise sur le march e
pour l ixazomib, un inhibiteur oral exp erimental du prot easome, en vue
du traitement des patients atteints de my elome multiple r ecurrent ou
r efractaire aux m edicaments.
Le dossier d autorisation de mise sur le march e se fonde sur l etude
clinique de phase III TOURMALINE-MM1, un essai clinique international,
randomis e, `a double insu, contr^ol e par placebo, men e aupr`es de 722
patients dans le but d evaluer la sup eriorit e de l ixazomib en
association avec le l enalidomide et la dexam ethasone sur un placebo en
association avec le l enalidomide et la dexam ethasone chez des patients
adultes atteints de my elome multiple r ecurrent et/ou r efractaire. About Indocin Sr (Indomethacin) without Rx Durant
l essai clinique, les patients poursuivent leur traitement et les
r esultats `a long terme sont evalu es.
« L etude TOURMALINE-MM1 est la premi`ere d une s erie de cinq essais
cliniques de phase III faisant partie de notre programme sur l ixazomib,
lequel a pour but d evaluer si un traitement prolong e par un inhibiteur
du prot easome, par voie orale, am eliore les r esultats cliniques des
patients atteints de my elome multiple ou d amylose A, a d eclar e Andrew
Plump, M.D., Ph. About Nizoral Cream (Ketoconazole) with free prescription D., m edecin-chef et conseiller scientifique en chef de
Takeda. About Viagra Soft (Sildenafil Citrate) with free Rx Cette pr esentation t emoigne de l engagement continu de Takeda `a
innover au service des patients atteints de my elome multiple. About Detrol with free prescription Nous
remercions les patients et leur famille de la confiance qu ils accordent
`a Takeda et `a l ixazomib en participant au programme TOURMALINE. Vitamin B12 (Methylcobalamin) with no Rx »
« La continuit e du traitement chez les patients atteints de my elome
multiple est maintenant accept ee comme norme de traitement etant donn e
l am elioration des r esultats `a long terme, a fait remarqu e Paul
Richardson, M.D., directeur du programme clinique et directeur de la
recherche, Jerome Lipper Multiple Myeloma Center, m edecin au Dana-Farber
Cancer Institute. Buy Stevia online L inhibition du prot easome est devenue une composante
essentielle du traitement, mais les approches intraveineuses et
sous-cutan ees posent des probl`emes d ordre logistique aux patients, en
particulier en l absence d option orale efficace. http://webmdhelper.wordpress.com S il est approuv e,
l ixazomib devrait repr esenter une avanc ee significative pour nos
patients, etant donn e son efficacit e et la commodit e d une
administration orale hebdomadaire. »
Il s agit de la premi`ere pr esentation r eglementaire concernant
l ixazomib. D autres dossiers seront d epos es en Europe et dans d autres
pays plus tard cette ann ee.
`A propos du my elome multipleLe my elome multiple est un
cancer du sang qui se d eclare dans la moelle osseuse. La maladie se
caract erise par la prolif eration de cellules plasmatiques anormales.
Parce les cellules plasmatiques circulent largement dans le corps, elles
peuvent affecter de nombreux os et entra^iner des fractures par
tassement, des l esions osseuses lytiques et de la douleur. Le my elome
multiple peut entra^iner nombre de graves probl`emes de sant e touchant les
os, le syst`eme immunitaire, les reins et le nombre de globules rouges
dans le sang, les sympt^omes les plus courants etant notamment des
douleurs aux os et de la fatigue, un signe d an emie. Le my elome multiple
est une forme de cancer relativement rare. Chaque ann ee, environ 20 000
nouveaux cas sont d eclar es aux Etats-Unis et il y a 114 000 nouveaux cas
`a l echelle mondiale.
`A propos de l ixazomibL’ixazomib (MLN9708) est un
inhibiteur oral exp erimental du prot easome `a l etude dans le traitement
du my elome multiple, de l’amylose AL et d autres affections malignes.
L’ixazomib a recu la d esignation de m edicament orphelin pour le my elome
multiple aux Etats-Unis et en Europe en 2011, et pour l’amylose AL aux
Etats-Unis et en Europe en 2012. En 2014, la Food and Drug
Administration (FDA) des Etats-Unis a accord e `a l’ixazomib la
d esignation « th erapie r evolutionnaire » pour les patients atteints
d amylose AL r ecurrente ou r efractaire. Il s’agit egalement du premier
inhibiteur oral du prot easome `a faire l objet d essais cliniques de
phase III.
Le programme de d eveloppement clinique de l ixazomib souligne
l engagement constant de Takeda `a mettre au point des m edicaments
novateurs au profit des personnes souffrant de my elome multiple dans le
monde entier et des professionnels de la sant e qui participent `a leur
traitement. Cinq essais mondiaux de phase III sont en cours :
TOURMALINE-MM1, qui etudie l’ixazomib comparativement au placebo en
association avec le l enalidomide et la dexam ethasone pour le my elome
multiple r ecurrent et/ou r efractaire
TOURMALINE-MM2, qui etudie l’ixazomib comparativement au placebo en
association avec le l enalidomide et la dexam ethasone chez des patients
atteints d un my elome multiple nouvellement diagnostiqu e
TOURMALINE-MM3, qui etudie l’ixazomib comparativement au placebo comme
traitement d entretien chez des patients atteints d un my elome
multiple nouvellement diagnostiqu e apr`es un premier traitement et une
greffe de cellules souches autologue
TOURMALINE-MM4, qui etudie l’ixazomib comparativement au placebo comme
traitement d entretien chez des patients atteints d un my elome
multiple nouvellement diagnostiqu e qui n ont pas subi de greffe de
cellules souches autologue
TOURMALINE-AL1, qui etudie l’ixazomib en association avec la
dexam ethasone comparativement `a une s election de sch emas
th erapeutiques au choix du m edecin chez des patients ayant une amylose
AL r ecurrente ou r efractaire
Pour en apprendre plus sur les etudes de phase III en cours, visitez le
site .clinicaltrials.gov.
`A propos de Takeda OncologyTakeda Oncology est une unit e
commerciale d envergure mondiale de Millennium Pharmaceuticals inc., une
filiale en propri et e exclusive de Takeda Pharmaceutical Company Limited.
Takeda aspire `a gu erir le cancer en mettant au point de nouveaux
m edicaments afin de r epondre aux besoins uniques et pressants des
personnes atteintes d un cancer, de leurs proches et des fournisseurs de
soins de sant e dans le monde entier. Takeda arrive au 11e
rang mondial des soci et es pharmaceutiques sp ecialis ees en oncologie.
Elle compte un portefeuille de m edicaments aptes `a modifier les
paradigmes de traitement et plusieurs produits exp erimentaux qui ont le
potentiel d am eliorer consid erablement les r esultats des patients
atteints de diff erents cancers. En alliant le pouvoir de la recherche
scientifique `a l esprit d entreprise et aux vastes ressources d une
soci et e pharmaceutique mondiale, Takeda Oncology trouve des facons
nouvelles et novatrices d am eliorer le traitement du cancer. Pour
obtenir de plus amples renseignements sur Takeda Oncology, consultez son
site Web `a l adresse .takedaoncology.com.
`A propos de TakedaTakeda est une soci et e pharmaceutique
d envergure mondiale ax ee sur la recherche. Son si`ege social est situ e `a
Osaka, au Japon. La plus grande soci et e pharmaceutique au Japon et un
des leaders mondiaux dans son secteur, Takeda concentre ses efforts sur
l am elioration de la sant e des patients `a travers le monde au moyen
d innovations m edicales de premier plan. Pour de plus amples
renseignements sur Takeda, consultez le site Web de la soci et e `a
l adresse .takeda.com.
Le texte du communiqu e issu d’une traduction ne doit d’aucune mani`ere
^etre consid er e comme officiel. La seule version du communiqu e qui fasse
foi est celle du communiqu e dans sa langue d’origine. La traduction
devra toujours ^etre confront ee au texte source, qui fera jurisprudence.
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