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Sunday, December 6, 2015
bluebird bio Presents Pre-Clinical and Manufacturing Data from CAR T Oncology Programs at ASH Annual Meeting
ORLANDO, Fla.--(BUSINESS WIRE)--bluebird bio, Inc. Kemadrin (Procyclidine) with free Rx (NASDAQ:BLUE), a clinical-stage company committed to
developing potentially transformative gene therapies for severe genetic
diseases and T cell-based immunotherapies for cancer, announced that
pre-clinical data from its anti-BCMA oncology program were presented by
bluebird bio scientists at the 57th American Society of
Hematology Annual Meeting.
“We believe the unique science and translational gene therapy platforms
we have built differentiate bluebird bio in the oncology field and have
the potential to yield important new therapies for patients living with
cancer. Myambutol (Ethambutol) with free Rx Our three oncology posters at ASH this year, covering critical
basic research, translational and manufacturing aspects of our T cell
oncology pipeline, demonstrate the strength of our T cell immunotherapy
translational science,” said Rob Ross, M.D., head of oncology, bluebird
bio. About Coumadin (Warfarin) with no prescription “We are also excited to see the first anti-BCMA clinical data from
Dr. Intagra with free prescription Jim Kochenderfer of the National Cancer Institute, which was
highlighted in yesterday’s press release from ASH. About Cardura (Doxazosin mesylate) We believe these data
provide excellent proof of concept for bb2121 and are pleased that Jim
will serve as one of the principal investigators for our Phase 1 study
of bb2121.”
Abstract #1893: Manufacturing an Enhanced CAR T Cell Product by
Inhibition of the PI3K/Akt Pathway During T Cell Expansion Results in
Improved In Vivo Efficacy of Anti-BCMA CAR T Cells
Overview and results, presented by Molly Perkins, D.Phil., bluebird bio,
include:
bluebird bio explored the potential for culture modifications to
improve the therapeutic potential of CAR T cells without adding
complexity to manufacturing. Buy Hoodia Diet Pills online The company tested this hypothesis using
CAR T cells specific to B cell maturation antigen (BCMA) manufactured
using standard IL-2 culture with an inhibitor of PI3K added to the
media, or with IL-7 and IL-15, in place of IL-2.
In an in vivo aggressive lymphoma model, mice treated with
anti-BCMA CAR T cells cultured only with IL-2 experienced no effect on
tumor growth and succumbed to the tumors within two weeks after
treatment; anti-BCMA CAR T cells grown in IL-7 and IL-15 also did not
affect tumor growth. http://medical-reviews.blogspot.com In contrast, mice treated with anti-BCMA CAR T
cells cultured with IL-2 and an inhibitor of PI3K experienced complete
and long-term tumor regression.
In an in vivo multiple myeloma model, mice received a single
administration of anti-BCMA CAR T cells cultured under various
conditions; all treatment groups demonstrated tumor regression
regardless of culture conditions. In a model of tumor relapse, two
weeks after tumor clearance, surviving mice were re-challenged with
the same multiple myeloma tumors on the opposite flank; only animals
that had been treated with anti-BCMA CAR T cells cultured with the
PI3K inhibitor were able to resist subsequent tumor challenge.
These data suggest that inhibition of PI3K during ex vivo
expansion may generate a superior anti-BCMA CAR T cell product for
clinical use; this approach could potentially apply to the manufacture
of CAR T cell therapies against other oncology targets.
Abstract #3094: A Novel and Highly Potent CAR T Cell Drug Product for
Treatment of BCMA-Expressing Hematological Malignancies
Overview and results, presented by Alena Chekmasova, Ph.D., bluebird
bio, include:
bluebird bio has developed a CAR targeting BCMA (bb2121) that consists
of an extracellular single chain variable fragment scFv antigen
recognition domain derived from antibodies to BCMA linked to CD137
(4-1BB) co-stimulatory and CD3zeta chain signaling domains.
Based on receptor density quantification, bb2121 can recognize tumor
cells expressing less than 1,000 BCMA molecules per cell.
In a preclinical BCMA+ multiple myeloma xenograft model, a single IV
administration of bb2121 anti-BCMA CAR T cells resulted in rapid and
sustained elimination of the tumors with 100 percent survival, while a
month-long course of anti-myeloma therapy Velcade® (bortezomib)
only delayed tumor growth.
Using flow cytometry and immunohistochemistry, bb2121 T cells were
shown to rapidly target and infiltrate tumors, and T cell expansion
was correlated with tumor regression.
bb2121 anti-BCMA CAR T cells also induced xenograft regression and
enhanced survival in a preclinical model of advanced Burkitt’s
lymphoma.
Taken together, these studies support the potential clinical
application of bb2121 for the treatment of patients with tumors
expressing BCMA.
Abstract #3243: Characterization of Lentiviral Vector Derived
Anti-BCMA CAR T Cells Reveals Key Parameters for Robust Manufacturing of
Cell-Based Gene Therapies for Multiple Myeloma
Overview and results, presented by Graham W.J. Lilley, M.Sc., bluebird
bio, include:
Successful personalized medicine will require robust and reproducible
drug product manufacturing. A series of experiments were conducted to
determine whether variations in anti-BCMA CAR surface expression
resulted in changes in the activity of CAR T cells.
T cells transduced with varying amounts of virus to yield different
amounts of CAR surface expression were diluted with donor-matched
untransduced cells to achieve a uniform population of T cells
containing 26 ± 4 percent anti-BCMA CAR T cells. When exposed to
tumor, these CAR T cell populations exhibited no difference in
cytotoxicity against BCMA-expressing cells.
All T cell productions easily achieved a level of anti-BCMA CAR
expression that resulted in potent anti-BCMA activity, thus potency of
the final drug product was shown to be independent of total anti-BCMA
CAR expression on the cell surface.
These data show that the bluebird bio T cell manufacturing process has
the potential to overcome significant challenges associated with
personalized medicine by reducing the effects of variability while
maintaining potency in autologous cellular drug product manufacturing.
Investor Webcast Information
bluebird bio will host an investor event that will be webcast live at
8:30 p.m. ET today, December 6, 2015, to discuss the ASH data and
provide a brief overview of the science and clinical development plans
surrounding the gene therapy, genome editing and immunotherapy programs.
The live webcast can be accessed under "Calendar of Events" in the
Investors and Media section of the company s website at .bluebirdbio.com.
The webcast will be available for replay for 30 days on the company
website. Alternatively, investors may listen to the call by
dialing (844) 825-4408 from locations in the United States or (315)
625-3227 from outside the United States. Please refer to conference ID
number 71438159.
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise
and gene editing capabilities, bluebird bio has built an integrated
product platform with broad potential application to severe genetic
diseases and cancer. bluebird bio’s gene therapy clinical programs
include its Lenti-D™ product candidate, currently in a
Phase 2/3 study, called the Starbeam Study, for the treatment of
childhood cerebral adrenoleukodystrophy, and its LentiGlobin® BB305
product candidate, currently in three clinical studies for the treatment
of beta-thalassemia major and severe sickle cell disease. bluebird bio’s
oncology pipeline is built upon the company’s leadership in lentiviral
gene delivery and T cell engineering, with a focus on developing novel T
cell-based immunotherapies, including chimeric antigen receptor (CAR T)
and T cell receptor (TCR) therapies. bluebird bio’s lead oncology
program, bb2121, is an anti-BCMA CAR T program partnered with Celgene
and focused on hematologic malignancies. bluebird bio also has discovery
research programs utilizing megaTALs/homing endonuclease gene editing
technologies with the potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge, Massachusetts, Seattle,
Washington, and Paris, France.
LentiGlobin and Lenti-D are trademarks of bluebird bio, Inc.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995, including
statements regarding the clinical potential and manufacturing of the
Company’s anti-BCMA oncology program, including its bb2121 product
candidate. Any forward-looking statements are based on management’s
current expectations of future events and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include, but
are not limited to, the risk that the preclinical efficacy and
safety data for our bb2121 product candidate will not be observed in our
planned clinical studies, the risk of cessation or delay of any of the
ongoing or planned clinical studies and/or our development of our
product candidates, the risk of a delay in the enrollment of patients in
our clinical studies, the risk that our collaboration with Celgene
Corporation will not continue or will not be successful, and the risk
that any one or more of our product candidates will not be successfully
developed and commercialized. For a discussion of other risks and
uncertainties, and other important factors, any of which could cause our
actual results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in our most recent
quarterly report on Form 10-Q, as well as discussions of potential
risks, uncertainties, and other important factors in our subsequent
filings with the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and bluebird bio
undertakes no duty to update this information unless required by law.
Monday, November 2, 2015
Veeva Preferred Partner Paragon To Address IDMP Preparations at 2015 Veeva R&D Global Summit
Saturday, October 24, 2015
Antares Vision Introduces Its New Corporate Campus to Customers, Suppliers, Employee Families, and the Public October 20-25, 2015
TRAVAGLIATO, Italy & MT. Detrol La (Tolterodine) with free prescription LAUREL, N.J.--(BUSINESS WIRE)--Antares
Vision, a leading supplier of inspection and track and trace systems
for the pharmaceutical industry, began today a six-day series of events
in celebrating the completion of its new corporate campus in
Travagliato. Buy Rhinocort (Budesonide) with free Rx Activities include technical meetings with supply chain
partners and leading global pharmaceutical companies that are members of
the company’s users group, technology demonstrations, family and general
public open houses, and the unveiling of original contemporary artwork
commissioned for the new corporate campus. About Periactin (Cyproheptadine) without prescription The company’s North American
headquaters is in Mt. Haldol without prescription Laurel, New Jersey.
The new Antares Vision campus in Travagliato, which is about 50 miles
(82 kilometers) northeast of Milan, triples the space formerly available
to the company and will initially accommodate more than 150 staffers. Buy Diabecon () with free prescription
The campus includes a new 29,000-square-foot (2,700-square-meter)
three-story headquarters facility, a new 6,500-square-foot
(600-square-meter) customer and employee training center with technology
demonstration areas, and a renovated 19,000-square-foot
(1800-square-meter) state-of-the-art manufacturing and global
distribution center.
“2015 has been momentous for our eight-year-old company,” said Emidio
Zorzella, Antares Vision CEO. Buy Foot Care online “We were named one of the top businesses
in Europe with special mention of our global growth strategy. http://medical-questions-answers.blogspot.com Many of
the world’s top 20 pharmaceutical companies became members of our new
users group. We saw the installation of our 100th track and
trace system and our 500th serialization line, and now we are
dedicating a stunningly beautiful corporate campus in Northern Italy. We
have a team of people that simply cannot be beat in terms of
pharmaceutical inspection and track and trace technology expertise and
dedication to customer service.”
Partner and customer conferences to discuss future innovationsFour
days (October 20-23) of the six-day celebration focus on upcoming
technology developments for pharmaceutical track and trace and the
market and regulatory trends helping to shape those developments. During
these four days, Antares Vision will host key members of its supply
chain, including manufacturers’ representatives, system integrators, and
original equipment manufacturers (OEMs) at these meetings.
Following the sales channel meetings, the company will convene the first
gathering of its users group at the new campus. The users group includes
representatives of many of the top 20 pharmaceutical companies in the
world and discusses best practices. In addition to Antares Vision talks
and technology demonstrations, there will be presentations by: Jean Marc
Bob ee, Director, Industrial Anti-Counterfeiting Strategy at Sanofi; Ian
Personage, Director, Global Serialization Services at PCI, the largest
co-packer in the world; Marcelo Liebhardt, Director of Economic Affairs
of the Interfarma, the Brazilian association of the Pharma Industry; and
Luis Cassapula and Am`erico Souza, Serialization Project Manager and IT
Lead respectively at Brazilian Ach e. After the user group event, there
will be an open houses and product demonstrations for selected customers
and sales channel representatives.
Family, members of the public, and contemporary artOn
Saturday, October 24, the company will open its doors to employee
families and will feature product demonstrations as well as building
tours and refreshments. On Sunday, the public will have the opportunity
to become acquainted with pharmaceutical inspection and tracking and
tracing systems. The public will also have the opportunity of seeing for
the first time a collection of contemporary works by noted Italian
artist Davide Mancini Zanchi. The contemporary pieces, which will be on
permanent display, are based on actual pharmaceutical plant images taken
with Antares Vision machine vision systems. Zanchi’s interpretations of
these images are digitally printed on metal photo panels.
Technology leaders at pharmaceutical companies large and small should
visit .antaresvision.com
to learn more about the company’s extensive line of products and systems
and its passion to help customers succeed in serialization and track and
trace. A complete list of the company’s international offices, including
sales partners, is available on the website.
About Antares VisionAntares Vision transforms knowledge and
technology into solutions and best practices for the pharmaceutical
industry and therefore, ultimately, for patients and for all of us.
Customer satisfaction, a global approach to in-line and off-line quality
control, creative use of the most innovative technologies in order to
supply reliable, long-lasting and user friendly solutions: these are the
distinguishing features of Antares Vision’s industry leading technology
and dedication to customer support and service. Antares Vision Corporate
headquarters is in Travagliato, Brescia, Italy.
Monday, October 5, 2015
La Administraci'on de Medicamentos y Alimentos de EEUU aprueba nuevo tratamiento combinado de Letairis® con Tadalafil de Gilead para la hipertensi'on arterial pulmonar (grupo 1 de la OMS)
FOSTER CITY, California--(BUSINESS WIRE)--Gilead Sciences, Inc. Buy Avodart (Dutasteride) with no Rx (Nasdaq:GILD) ha anunciado hoy que la
Administraci on de Medicamentos y Alimentos de EEUU (FDA) ha aprobado el
uso de Letairis® (ambrisent an) en combinaci on con tadalafil
para el tratamiento de la hipertensi on arterial pulmonar (HAP) (grupo 1
de la OMS) para reducir el riesgo de progresi on de la enfermedad y la
hospitalizaci on por empeoramiento de HAP, y para mejorar la capacidad de
ejercicio. Viagra Gold (Sildenafil Citrate + L-Arginine + Giseng + Vitamin B6 + Folic Acid) Letairis es un antagonista receptor de la endotelina que fue
aprobado por primera vez en 2007 en EEUU, como monoterapia para HAP para
mejorar la capacidad de ejercicio y retraso del empeoramiento cl inico. Buy Betapace (Sotalol) with free prescription
Tadalafil es un inhibidor de PDE5 que fue inicialmente aprobado para HAP
en EEUU en 2009 para mejorar la capacidad de ejercicio.
“Las pruebas a favor del uso de ambrisent an y tadalafil en HAP han sido
s olidamente demostradas. Frontier without prescription No obstante, queda una pregunta pendiente, la
de saber si la combinaci on de estos dos medicamentos como terapia
inicial podr ia retrasar la progresi on de la enfermedad a largo plazo
para los pacientes que acaban de iniciar un tratamiento contra HAP”,
comenta Ronald J. Buy Glucotrol (Glipizide) without Rx Oudiz, MD, Profesor de Medicina de la David Geffen
School of Medicine de UCLA y Director del Liu Center for Pulmonary
Hypertension, Los Angeles Biomedical Research Institute en Harbor-UCLA
Medical Center. Buy DHEA online “Bas andonos en los datos que respaldan la aprobaci on de
hoy, ya sabemos que los pacientes que reciben ambrisent an y tadalafil
como terapia inicial son menos propensos a registrar una progresi on de
la enfermedad o de ser hospitalizados, y presentan una mejora en la
capacidad de ejercicio que los pacientes que reciben unicamente
cualquiera de estos tratamientos eficaces. http://doctor-consult.blogspot.com Por lo tanto, esta
combinaci on representa una nueva estrategia de tratamiento para los
pacientes que viven con esta enfermedad potencialmente mortal y
debilitante”.
El nuevo etiquetado est a respaldado por datos del estudio AMBITION (un
estudio aleatorio, de doble anonimato y multic entrico de la terapia de
combinaci on de primera l inea con AMBrIsent an y Tadalafil
en pacientes con HipertensION arterial pulmonar). En
AMBITION, 605 pacientes con HAP de clase funcional II o III de la OMS
fueron asignados de forma aleatoria (2:1:1) para recibir una sola dosis
diaria de Letairis m as tadalafil (n=302) o de Letairis (n=152) o
tadalafil (n=151) de forma independiente. El tratamiento fue iniciado
con Letairis 5 mg y tadalafil 20 mg. Si se toleraba, se aument o la dosis
de tadalafil a 40 mg a las cuatro semanas y de Letairis a 10 mg a las
ocho semanas. El criterio principal de valoraci on fue el tiempo hasta el
primer fallecimiento, hospitalizaci on por empeoramiento de HAP, el
descenso superior al 15% con respecto a la distancia de seis minutos de
caminata (6MWD) combinado con s intomas de clase funcional III o IV de la
OMS sostenidos durante 14 d ias (empeoramiento cl inico a corto plazo) o
reducci on en 6MWD sostenida durante 14 d ias combinada con s intomas de
clase funcional III o IV de la OMS sostenidos durante 6 meses (respuesta
cl inica inadecuada a largo plazo).
En el estudio, la terapia de combinaci on con Letairis y tadalafil
demostr o una superioridad en la reducci on del riesgo del criterio de
valoraci on principal compuesto en un 49% y 45%, respectivamente, con
respecto a la monoterapia con Letairis (cociente de riesgo= 0,51; 95%
IC: 0,35, 0,73; p=0,0002) o tadalafil (cociente de riesgo = 0,55; 95%
IC: 0,37, 0,81; p=0,002). En general, el 20% de los pacientes que
recibieron la terapia combinada registraron un caso de criterio de
valoraci on principal en comparaci on con el 35% y el 30%,
respectivamente, en pacientes que recibieron Letairis o tadalafil.
La terapia de combinaci on tambi en demostr o una reducci on del riesgo de
hospitalizaci on por empeoramiento de HAP del 67% y del 56%,
respectivamente, en comparaci on con Letairis (cociente de riesgo = 0,33;
95% IC: 0,19, 0,55) o tadalafil (cociente de riesgo = 0,44; 95% IC:
0,25, 0,79). En general, el 8% de los pacientes que recibieron la
terapia combinada fueron hospitalizados por empeoramiento de HAP en
comparaci on con el 22% y el 15%, respectivamente, en pacientes que
recibieron Letairis o tadalafil.
Los pacientes que recibieron Letairis m as tadalafil tambi en
experimentaron mejoras estad isticamente significativas con respecto a la
l inea de base en 6MWD frente a la monoterapia individual, con una
diferencia media de 24 metros y 20 metros, respectivamente, con respecto
a Letairis (95% IC: 11, 37; p=0,0004) o tadalafil (95% IC: 8, 32;
p=0,0016) en la semana 24.
Cuando Letairis se utiliza en combinaci on con tadalafil, las reacciones
adversas m as frecuentes ( >5% que cualquiera de las monoterapias) fueron
edema perif erico (Combinaci on: 45%; Letairis: 38 %; tadalafil: 28 %),
dolor de cabeza (Combinaci on: 41%; Letairis: 34%; tadalafil: 35%),
congesti on nasal (Combinaci on: 19%; Letairis: 16%; tadalafil: 11%), tos
(Combinaci on: 18%; Letairis: 13%; tadalafil: 16%), anemia (Combinaci on:
15%; Letairis: 7%; tadalafil: 11%), dispepsia (Combinaci on: 11%;
Letairis: 3 %; tadalafil: 12 %) y bronquitis (Combinaci on: 10%;
Letairis: 4%; tadalafil: 9%). Letairis cuenta con una etiqueta deADVERTENCIA
ESPECIAL y un programa asociado de estrategia de mitigaci on y
evaluaci on del riesgo (REMS) en relaci on con el riesgo de toxicidad
embrionaria y fetal; v ease m as abajo la informaci on de seguridad
importante de EEUU para Letairis.
Los datos de AMBITION han sido publicados en The New England
Journal of Medicine y Letairis m as tadalafil fue la unica
opci on recomendada de tratamiento de combinaci on inicial para HAP en las
“2015 European Society of Cardiology / European Respiratory Society
Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension”
(Directrices de la sociedad respiratoria europea/sociedad de cardiolog ia
europea 2015 para el diagn ostico de la hipertensi on pulmonar) publicadas
en el European Heart Journal de agosto, 2015.
AMBITION ha sido copatrocinado por Gilead y GlaxoSmithKline (GSK). Eli
Lilly and Company tambi en han proporcionado financiaci on y el suministro
del f armaco tadalafil para el ensayo. Gilead comercializa ambrisent an
bajo el nombre comercial de Letairis en EEUU y GSK comercializa
ambrisent an bajo el nombre comercial de Volibris® en
territorios fuera de EEUU.
Acerca de la hipertensi on arterial pulmonar
(grupo 1 de la OMS)
La HAP es una enfermedad debilitante caracterizada por la constricci on
de los vasos sangu ineos en los pulmones, que provoca alta presi on
arterial pulmonar. Estas altas presiones dificultan al coraz on bombear
sangre a trav es de los pulmones para que se oxigene. Los pacientes con
HAP padecen dificultades respiratorias ya que el coraz on se esfuerza por
bombear contra estas altas presiones, lo que provoca que, finalmente,
los pacientes fallezcan por insuficiencia card iaca. La HAP puede
producirse sin causa subyacente conocida o puede ser causada a partir de
enfermedades como la enfermedad del tejido conjuntivo, anomal ias
card iacas cong enitas, cirrosis del h igado e infecci on de VIH.
Acerca de Letairis
Letairis est a indicado para el tratamiento de la hipertensi on arterial
pulmonar (HAP) (grupo 1 de la OMS) para mejorar la capacidad de
ejercicio y retrasar el empeoramiento cl inico; y en combinaci on con
tadalafil para reducir el riesgo de la progresi on de la enfermedad y la
hospitalizaci on por empeoramiento de HAP, y para mejorar la capacidad de
ejercicio. Los estudios que establecen la eficacia incluyen sobre todo a
pacientes con s intomas de clase funcional II-III de la OMS y etiolog ias
de HAP idiop atica o hereditaria (60%) o HAP relacionada con enfermedades
del tejido conjuntivo (34%).
Informaci on importante de seguridad para
Letairis en EEUU.
ADVERTENCIA ESPECIAL: TOXICIDAD EMBRIONARIA Y FETAL
No administre Letairis a embarazadas porque podr ia provocar da~nos
en el feto. Es muy probable que Letairis provoque graves anomal ias
cong enitas si es administrado a embarazadas, ya que se ha observado
este efecto consistentemente en animales.
Debe descartarse la posibilidad de embarazo antes de iniciar el
tratamiento con Letairis. Las mujeres en edad f ertil deben emplear
m etodos anticonceptivos aceptables durante el tratamiento con
Letairis, y durante un mes despu es del tratamiento. Han de realizarse
pruebas de embarazo mensuales durante el tratamiento y durante un mes
tras la interrupci on del tratamiento.
Debido al riesgo de anomal ias cong enitas causadas por toxicidad
embrionaria y fetal, las mujeres solo pueden tomar Letairis bajo el
control de un programa restringido denominado programa Letairis REMS.
Contraindicaciones
Embarazo: Letairis podr ia provocar da~nos en el feto.
Fibrosis pulmonar idiop atica (FPI), incluidos los
pacientes con FPI e hipertensi on pulmonar (grupo 3 de la OMS).
Advertencias y precauciones
Toxicidad embrionaria y fetal y requisitos del programa Letairis
REMS:
Los m edicos que extiendan su receta deben tener la certificaci on
del programa por haberse inscrito y completado la formaci on.
Todas las pacientes mujeres, independientemente de su potencial
reproductivo, pueden inscribirse en el programa Letairis REMS
Los pacientes varones no se inscriben en el programa
Las farmacias deben tener la certificaci on del programa y pueden
administrar a las pacientes mujeres que est an autorizadas a
recibir Letairis
M as informaci on disponible en .letairisrems.com o
1-866-664-5327.
Edema perif erico: el edema perif erico es conocido por ser un efecto de
clase de los antagonistas de los receptores de la endotelina, y es
tambi en una consecuencia cl inica de HAP y de empeoramiento de HAP.
Conviene evaluar primero a los pacientes que desarrollen retenciones
de fluidos cl inicamente significativos para determinar la causa y la
posible necesidad de un tratamiento con edema o interrumpir Letairis.
En estudios cl inicos, el edema perif erico fue m as frecuente con
Letairis que con placebo (la gravedad de la mayor ia de los edemas fue
de leve a moderado); y con Letairis m as tadalafil que con cualquiera
de los f armacos solos. Existen informes posteriores a la
comercializaci on que se~nalan retenci on de fluidos producida unas
semanas despu es de empezar a tomar Letairis, que requiri o intervenci on
con un tratamiento diur etico o, en algunos casos, con la
hospitalizaci on, para descompensar la insuficiencia card iaca.
Edema pulmonar con enfermedad venooclusiva (PVOD): Conviene
evaluar PVOD en los pacientes que desarrollan edema pulmonar agudo
durante el inicio del tratamiento con Letairis, e interrumpir el
tratamiento con Letairis si se confirmara.
Se ha observado una disminuci on del n umero de espermatozoides en
pacientes que toman antagonistas de los receptores de endotelina y en
estudios de fertilidad animal con ambrisent an. Es preciso orientar a
los pacientes sobre los posibles efectos sobre la fertilidad.
Cambios hematol ogicos: Medir la hemoglobina antes de iniciar
tratamiento con Letairis, en el primer mes, y de forma peri odica
despu es. El inicio del tratamiento con Letairis no se recomienda a
aquellos pacientes con anemia cl inicamente significativa. Evaluar la
interrupci on de Letairis si se producen descensos cl inicamente
significativos en la hemoglobina y si se han excluido otras causas. Se
han observado descensos en la hemoglobina y hematrocritos en las
primeras semanas de iniciar tratamiento con Letairis, que podr ia
mantenerse durante el tratamiento. Existen informes posteriores a la
comercializaci on que se~nalan casos de anemia que requirieron
transfusiones.
Rcciones adversas
La reacciones adversas m as frecuentes cuando se utiliza como
monoterapia en comparaci on con placebo fueron el edema
perif erico (17% frente al 11%), la congesti on nasal (6% frente al 2%),
sinusitis (3% frente al 0%) y rubor (4% frente al 1%).
Las reacciones adversas m as frecuentes en combinaci on con tadalafil en
comparaci on con la monoterapia de Letairis o tadalafil fueron edema
perif erico (45% frente al 38% o 28%), dolor de cabeza (41% frente al
34% o 35%), congesti on nasal (19% frente al 16% o 11%), tos (18%
frente al 13% o 16%), anemia (15% frente al 7% o 11%), dispepsia (11%
frente al 3% o 12%) y bronquitis (10% frente al 4% o 9%).
Interacciones con otros f armacos
La ciclosporina multiplica por dos la exposici on a
ambrisent an; limitar Letairis a 5 mg una vez al d ia
Uso en poblaciones espec ificas
Lactancia: elegir Letairis o lactancia.
Insuficiencia hep atica: Letairis no se recomienda a los
pacientes con insuficiencia hep atica moderada o grave. Investigar a
fondo la causa de la lesi on hep atica en pacientes que desarrollen
insuficiencia hep atica; interrumpir Letairis si las aminotransferasas
del h igado son >5x ULN o si las elevaciones est an acompa~nadas de
bilirubina >2x ULN, o de s intomas de disfunci on hep atica y se excluyen
otras causas.
Dosis y administraci on
Dosis para adultos: iniciar el tratamiento con Letairis con 5
mg una vez al d ia, y con o sin tadalafil 20 mg una vez al d ia. En
intervalos de 4 semanas, evaluar si se aumenta la dosis de Letairis a
10 mg o de tadalafil a 40 mg. No triture, mastique o rompa los
comprimidos.
Pruebas de embarazo: iniciar el tratamiento con Letairis en
mujeres en edad f ertil solo despu es de obtener una prueba de embarazo
negativa. Han de realizarse pruebas de embarazo mensuales durante el
tratamiento.
Acerca de Gilead Sciences
Gilead Sciences es una empresa biofarmac eutica centrada en el
descubrimiento, desarrollo y comercializaci on de productos terap euticos
innovadores en areas con necesidades m edicas no cubiertas. La misi on de
Gilead es avanzar en la atenci on a pacientes que padecen enfermedades
potencialmente letales en todo el mundo. Gilead cuenta con operaciones
en m as de 30 pa ises de todo el mundo, con sede central en Foster City,
California.
Afirmaciones referidas al futuro
Esta nota de prensa incluye afirmaciones referidas al futuro, al amparo
de lo previsto en la Ley de Reforma de Valores Privados de 1995, que
est an sujetos a riesgos e incertidumbres y otros factores, incluida la
posibilidad de que los m edicos no vean el beneficio de la terapia
combinada con Letairis y tadalafil. Estos riesgos, incertidumbres y
otros factores, pueden causar que los resultados actuales difieran de
forma material de aquellos referidos en las afirmaciones referidas al
futuro. Se advierte al lector que no conf ie en estas afirmaciones
referidas al futuro. Estos y otros riesgos se describen en detalle en el
informe anual de Gilead en el Formulario 10-Q para el trimestre cerrado
el 30 de junio, 2015, como se ha presentado ante la Comisi on de Valores
y Bolsa de EE.UU. (SEC en sus siglas en ingl es). Todas las afirmaciones
referidas al futuro se basan en la informaci on disponible actualmente
para Gilead, y Gilead no asume obligaci on alguna de actualizar ninguna
de estas afirmaciones referidas al futuro.
Toda la informaci on sobre la prescripci on en EEUU, incluida la ADVERTENCIA
ESPECIAL para Letairis, est a disponible en .gilead.com.
Letairis y Volibris son marcas comerciales registradas de Gilead
Sciences, Inc. o una de sus compa~n ias relacionadas.
M as informaci on sobre Gilead Sciences, en el sitio Web de la empresa
en .gilead.com,
siga a Gilead en Twitter (@GileadSciences)
o llame al Departamento de Relaciones P ublicas de Gilead en
1-800-GILEAD-5 o 1-650-574-3000.
El comunicado en el idioma original, es la versi on oficial y autorizada
del mismo. La traducci on es solamente un medio de ayuda y deber a
ser comparada con el texto en idioma original, que es la unica versi on
del texto que tendr a validez legal.
Friday, September 11, 2015
Trevena, Inc. Announces Pricing of Underwritten Offering of Common Stock
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Trevena, Inc. About Zetia (Ezetimibe) (NASDAQ: TRVN), a clinical stage pharmaceutical company,
today announced the pricing of an underwritten offering of 6,500,000
shares of its common stock, offered at a price to the public of $9.75
per share. Betapace (Sotalol) without Rx All of the shares of common stock to be sold in the offering
are to be sold by Trevena, Inc. Frumil (Amiloride) with no Rx Trevena, Inc. Fcn with no Rx has granted the
underwriters a 30-day option to purchase up to an additional 975,000
shares of common stock. Buy Menosan () with free prescription The offering is expected to close on or about
September 16, 2015, subject to customary closing conditions. Buy Carnosine online Jefferies
LLC, Cowen and Company, LLC and Barclays Capital Inc. http://webmd-review.blogspot.com are acting as
joint book-runners for the offering. JMP Securities LLC and Needham &
Company, LLC are acting as co-managers for the offering.
The gross offering size will be approximately $63.4 million, before
deducting customary underwriting discounts and commissions and offering
expenses.
Trevena, Inc. intends to use the net proceeds from the underwritten
offering, together with its existing cash and investments: to complete
Phase 3 development, submit a new drug application, and begin launch
preparations for TRV130; to complete its Phase 2b BLAST-AHF study for
TRV027; to complete initial Phase 1 studies for TRV250; to continue drug
discovery in new therapy areas; and for working capital and general
corporate purposes.
The securities described above are being offered pursuant to a shelf
registration statement (File No. 333-203230) that was filed with the
United States Securities and Exchange Commission (“SEC”) on April 3,
2015 and that was declared effective by the SEC on April 14, 2015. The
securities described above have not been qualified under any state blue
sky laws. This press release shall not constitute an offer to sell or
the solicitation of an offer to buy these securities, nor shall there be
any sale of these securities in any state or other jurisdiction in which
such offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
state or other jurisdiction. The offering can be made only by means of a
written prospectus and prospectus supplement that form a part of the
registration statement. A preliminary prospectus supplement and
accompanying prospectus relating to the offering have been filed with
the SEC and are available on the SEC’s website at .sec.gov.
A final prospectus supplement will be filed with the SEC. Copies of the
final prospectus supplement and the accompanying prospectus, when
available, may also be obtained by request at Jefferies LLC, Attention:
Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor,
New York, NY 10022, telephone: (877) 821-7388, e-mail: Prospectus_Department@Jefferies.com;
at Cowen and Company, LLC, c/o Broadridge Financial Services, Attention:
Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717,
Attn: Prospectus Department, telephone: (631) 274-2806; and at Barclays
Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island
Avenue, Edgewood, NY 11717, telephone: 888-603-5847, email: Barclaysprospectus@broadridge.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans
and prospects for Trevena, Inc., including statements about Trevena’s
anticipated public offering, anticipated use of proceeds and plans and
prospects for Trevena and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,” “could,”
“should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: the uncertainties related to
market conditions and the completion of the public offering on the
anticipated terms or at all, uncertainties inherent in the initiation of
future clinical trials and such other factors as are set forth in the
risk factors detailed in Trevena’s Annual Report on Form 10-K filed with
the SEC on March 18, 2015 and the preliminary prospectus supplement
filed with the SEC on September 10, 2015 under the heading “Risk
Factors.” In addition, the forward-looking statements included in this
press release represent Trevena’s views as of the date hereof. Trevena
anticipates that subsequent events and developments will cause Trevena’s
views to change. However, while Trevena may elect to update these
forward-looking statements at some point in the future, Trevena
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing Trevena’s views as
of any date subsequent to the date hereof.
Wednesday, September 2, 2015
Seasonal Allergic Rhinitis Pipeline Review 2015 - 9 Companies & 10 Drug Profiles
. Buy Bones online Suminat (Sumatriptan) with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/tmjv2f/seasonal_allergic)
has announced the addition of the "Seasonal
Allergic Rhinitis - Pipeline Review, H2 2015" report to their
offering.
This report provides comprehensive information on the therapeutic
development for Seasonal Allergic Rhinitis, complete with comparative
analysis at various stages, therapeutics assessment by drug target,
mechanism of action (MoA), route of administration (RoA) and molecule
type, along with latest updates, and featured news and press releases. http://pharmaceutical-journal.blogspot.com About Estriol About Vantin (Cefpodoxime) with no prescription
It also reviews key players involved in the therapeutic development for
Seasonal Allergic Rhinitis and special features on late-stage and
discontinued projects.
The report enhances decision making capabilities and help to create
effective counter strategies to gain competitive advantage. Buy Orlistat (Orlistat) with free Rx Buy Ciloxan (Ciprofloxacin) with free Rx It
strengthens R&D pipelines by identifying new targets and MOAs to produce
first-in-class and best-in-class products.
Companies Involved in Therapeutics Development
Adamis Pharmaceuticals Corporation
FAES Farma SA
GlaxoSmithKline Plc
Glenmark Pharmaceuticals Ltd.
Merck & Co., Inc.
Mitsubishi Tanabe Pharma Corporation
Ono Pharmaceutical Co., Ltd.
Shionogi & Co., Ltd.
VentiRx Pharmaceuticals, Inc.
Drug Profiles
(azelastine hydrochloride + mometasone furoate)
APC-3000
bepotastine besylate
bilastine
desloratadine
GSP-301
levocabastine hydrochloride
ONO-4053
S-555739
VTX-1463
For more information visit .researchandmarkets.com/research/tmjv2f/seasonal_allergic
Friday, August 28, 2015
Global mTORC-1 Inhibitors Pipeline Insights Review 2015
. Procardia (Nifedipine) with no Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/r87kfx/mtorc1)
has announced the addition of the "mTORC-1
Inhibitors -Pipeline Insights" report to their offering.
mTORC-1 Inhibitors Pipeline Insights provides the in-depth analysis of
the pipeline assets across the mTORC-1 Inhibitors. Buy Basil online About Stalevo (Carbidopa Levodopa Entacapone) The main objective of
this report to track competitor pipeline molecules, related research
activities, technology, collaborations, in-licensing and out-licensing
deals. http://webmd-consult.blogspot.com Dexone (Dexamethasone) The mTORC-1 Inhibitors Report helps to identify emerging players
with potentially strong product information and create effective
counter-strategies to gain competitive advantage.
mTORC-1 Inhibitors Pipeline Insights Report covers the mTORC-1
Inhibitors pipeline molecules at various stages of development like
Pre-registration phase, clinical phases (Phase III, Phase II & Phase I),
pre-clinical and discovery phases. Buy Zithromax (Azithromycin) with no prescription The Report also provides mTORC-1
Inhibitors related therapeutic assessments by molecule type, route of
administration, monotherapy and combination products. Endace The Report also
highlights the discontinued and inactive projects in pipeline for
mTORC-1 Inhibitors.
Scope
- The report provides a mTORC-1 Inhibitors Landscape across the globe
- The report provides drug profiles which includes product description,
MOA, licensors & collaborators, technology, development partner and
chemical information
- Coverage of the mTORC-1 Inhibitors pipeline on the basis of target,
MOA, route of administration, technology involved and molecule type
- The report reviews key players involved in the therapeutics
development for mTORC-1 Inhibitors and also provide company profiling
- Pipeline products coverage based on various stages of development from
NDA filings to discovery.
- Provides pipeline assessment by monotherapy and combination therapy
products, stage of development and molecule type
For more information visit .researchandmarkets.com/research/r87kfx/mtorc1
Wednesday, August 19, 2015
Global Pseudomonas Infections Pipeline Insights Review 2015
. Reminyl (Galantamine) without Rx DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/9c46dx/pseudomonas)
has announced the addition of the "Pseudomonas
Infections-Pipeline Insights" report to their offering.
This Pseudomonas Infections-Pipeline Insights, 2014, report provides
comprehensive insights about pipeline drugs across this indication. Buy Arthritis - Muscle Pain Relief online Buy Robaxin (Methocarbamol) without prescription A
key objective of the report is to establish the understanding for all
the pipeline drugs that fall under Pseudomonas Infections. http://medicalquestionanswers.wordpress.com About Effexor Xr (Venlafaxine) with no Rx This report
provides information on the therapeutic development based on the
Pseudomonas Infections dealing with all the pipeline drugs, comparative
analysis at various stages covering Filed, Phase III, Phase II, Phase I,
IND filed, Preclinical, Discovery and unknown stages, therapeutics
assessment by monotherapy and combination products and molecule type
drug information. Augmentin (Amoxicillin / Clavulanate ) with free Rx The report also covers the companies information
involved in the therapeutic development of the products. Buy Elixophyllin without prescription It also has
highlighted the discontinued and dormant products.
Scope
- The report provides a snapshot of the global therapeutic landscape of
Pseudomonas Infections
- The report provides pipeline products under drug profile section which
includes product description, MOA, licensors & collaborators,
development partner and chemical information
- Coverage of the Pseudomonas Infections pipeline on the basis of
target, MOA, route of administration, technology involved and molecule
type
- The report reviews key players involved in the therapeutics
development for Pseudomonas Infections and also provide company profiling
- The report also gives the information of dormant and discontinued
pipeline projects
- Pipeline products coverage based on various stages of development
ranging from preregistration till discovery and undisclosed stages
- Provides pipeline assessment by monotherapy and combination therapy
products, stage of development and molecule type
For more information visit .researchandmarkets.com/research/9c46dx/pseudomonas
Monday, August 17, 2015
Pivotal Phase II Study Showed Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Lung Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that in the large pivotal Phase II study, BIRCH, the
investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1)
met its primary endpoint and shrank tumors (objective response rate;
ORR) in people with locally advanced or metastatic non-small cell lung
cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death
Ligand-1). Buy Ocuflox (Ofloxacin) The study showed the amount of PD-L1 expressed by a person’s
cancer correlated with their response to the medicine. Buy Indocin Sr (Indomethacin) with no Rx Adverse events
were consistent with what has been previously observed for atezolizumab.
“We are encouraged by the number of people who responded to atezolizumab
and maintained their response during the study, which is particularly
meaningful for people who had received several prior treatments,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. About Female Cialis (Tadalafil) without Rx “We plan to present results at an upcoming medical meeting
and will discuss these data as well as results from our other lung
cancer studies with health authorities to bring this medicine to
patients as quickly as possible.’’
Earlier this year, the FDA granted atezolizumab a Breakthrough Therapy
Designation for the treatment of people whose NSCLC expresses PD-L1 and
who progressed during or after standard treatments (e.g., platinum-based
chemotherapy and appropriate targeted therapy for EGFR mutation-positive
or ALK-positive disease). About Doxepin with no prescription This designation is designed to expedite the
development and review of medicines intended to treat serious diseases. Super Kamagra (Sildenafil with Dapoxetine) with free Rx
We have seven Phase III studies evaluating atezolizumab alone or in
combination with other medicines as a potential new treatment for people
with early and advanced stages of lung cancer.
About the BIRCH Study
BIRCH is an open-label, multicenter, single-arm Phase II study that
evaluated the safety and efficacy of atezolizumab in 667 people with
locally advanced or metastatic NSCLC whose disease expressed PD-L1. Buy Weightlifting Gloves online
PD-L1 expression was assessed on both tumor cells (TC) and
tumor-infiltrating immune cells (IC) with an investigational
immunohistochemistry test (IHC) being developed by Roche Diagnostics. http://web-md.blogspot.com
Eligibility criteria included people whose tumors were determined to
express PD-L1 with an IHC score of TC2/3 or IC2/3. People in the study
received a 1200-milligram intravenous dose of atezolizumab every three
weeks. The primary endpoint of the study was ORR. Secondary endpoints
included duration of response (DoR), overall survival (OS),
progression-free survival (PFS) and safety. Results from BIRCH will be
presented at an upcoming medical meeting.
About Lung Cancer
According to the American Cancer Society, it is estimated that more than
221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC
accounts for 85 percent of all lung cancers. It is estimated that
approximately 60 percent of lung cancer diagnoses in the United States
are made when the disease is in the advanced stages.
About atezolizumab
Atezolizumab (also known as MPDL3280A; anti-PDL1) is an investigational
monoclonal antibody designed to interfere with a protein called PD-L1.
Atezolizumab is designed to target PD-L1 expressed on tumor cells and
tumor-infiltrating immune cells, preventing it from binding to PD-1 and
B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may
enable the activation of T cells.
All studies of atezolizumab include the evaluation of an investigational
IHC test that uses the antibody SP142 to measure PD-L1 expression on
both tumor cells and infiltrating immune cells. The goal of PD-L1 as a
biomarker is to identify those people most likely to benefit when
treated with atezolizumab alone, and to determine which people may
benefit most from a combination of atezolizumab and another medicine.
There are 11 ongoing or planned Phase III studies of atezolizumab across
certain kinds of lung, kidney, breast and bladder cancer.
About Genentech in Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the
goal to redefine treatment in oncology. Today, we’re investing more than
ever to bring personalized cancer immunotherapy (PCI) to people with
cancer. The goal of PCI is to provide each person with a treatment
tailored to harness his or her own immune system to fight cancer.
Genentech is studying more than 20 investigational medicines, seven of
which are in clinical trials. In every study we are evaluating
biomarkers to identify which people may be appropriate candidates for
our medicines. For more information visit .gene.com/immunotherapy.
About Genentech
Founded more than 35 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious or life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit .gene.com.
Monday, July 27, 2015
Edgemont Capital Partners Completes Sale of SCYNEXIS Contract Research and Development Business to Avista Pharma Solutions, an Ampersand Capital Partners Portfolio Company
NEW YORK & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Today Edgemont Capital Partners, a leading independent investment
banking firm providing merger and acquisition advisory services to
healthcare companies, announced that it acted as exclusive financial
advisor to SCYNEXIS, Inc. Buy Myambutol (Ethambutol) without Rx in the sale of its contract research and
development services business to Avista Pharma Solutions. Lamisil Cream (Terbinafine) without Rx The deal was
announced on July 23.
SCYNEXIS, a pharmaceutical company committed to the discovery,
development and commercialization of novel anti-infectives to address
significant unmet therapeutic needs, divested its contract research and
development business to focus on development of its lead compound
SCY-078. Buy Provera (Medroxyprogesterone Acetate) with no prescription The contract research and development business includes a novel
screening platform and technology utilized by leading animal health
companies, as well as Good Manufacturing Practices Active Pharmaceutical
Ingredient (GMP API) process chemistry and analytical service offerings
for biotech and pharmaceutical companies. About Divina with free Rx The transaction was led by
David Blume, Managing Director and Head of the firm’s Pharmaceutical
Services Group, Reid Petersen and Anish Dalsania.
“We are pleased to be part of this ‘win-win’ transaction which will
allow SCYNEXIS to focus on development of its lead asset SCY-078 and
provide a strong platform for this exceptional contract research,
development and manufacturing business to capitalize on the strong
market demand given the robust market conditions for outsourced
pharmaceutical services,” said Blume.
“Edgemont was instrumental to us achieving our goals in this
transaction, providing valuable advice and flawless execution. Terramycin (Oxytetracycline) without Rx We are
grateful for their efforts,” commented Dr. Buy Vitamin D online Marco Taglietti, CEO of
SCYNEXIS.
As part of the transaction, Avista will occupy SCYNEXIS’ former research
and GMP manufacturing facility in Durham, North Carolina and hire
substantially all employees associated with the contract services
research and development business. http://cholesterolreviews.wordpress.com Avista is a contract
development and manufacturing organization (CDMO) formed through the
recent, strategic carve-outs of the CMC business of Array BioPharma,
Inc. and contract services business of SCYNEXIS. Avista’s CEO is Patrick
Walsh. Avista is a business unit of Accuratus Lab Services, Inc.
(Accuratus). Accuratus is a portfolio company of Ampersand Capital
Partners.
About Edgemont Capital Partners
Edgemont Capital Partners, LP (.edgemontcapital.com)
is an independent investment banking firm founded in 2001 providing
merger and acquisition and financing advisory services to healthcare
companies. The firm’s deep healthcare industry knowledge and extensive
transaction expertise allows it to address healthcare companies
strategic (M&A) and financing needs with great success. The firm’s
principals have closed over 100 transactions, representing more than $30
billion in value.
For more information on Edgemont Capital Partners’ expertise in
pharmaceutical services and other healthcare sectors contact David Blume
at +1 (212) 867-8937 and visit .edgemontcapital.com.
Investment banking services are provided by Edgemont Capital Partners,
LP, a registered broker-dealer and member firm of FINRA and SIPC.
Thursday, July 16, 2015
Provectus Biopharmaceuticals, Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-Think Pharmaceutical Co., Ltd Continue Search for Agreement on PV-10 Use in China
KNOXVILLE, Tenn.--(BUSINESS WIRE)--Provectus Biopharmaceuticals, Inc. Buy Janumet (Sitagliptin Metformin) with free Rx (NYSE MKT: PVCT, .pvct.com),
a clinical-stage oncology and dermatology biopharmaceutical company
(“Provectus” or the “Company”), announced that it continues to work with
Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm
A-Think Pharmaceutical Co., Ltd to reach an agreement on PV-10 use in
China.
Discussions continue with the frame of reference established in the
original Memorandum of Understanding, or MOU, signed last year and
extended since the passing of the original deadline. About Nexium (Esomeprazole) without Rx The original MOU
was signed in August 2014, and, since then, the parties have sought to
enter into a definitive licensing agreement, subject to additional
negotiation, due diligence, and any required regulatory and corporate
approvals.
Since the signing of the MOU, management of Provectus and senior
personnel at Sinopharm-CSIPI and Sinopharm A-THINK have held numerous
conference calls, have met face-to-face in both China and the US, and
Chinese scientists on staff at Sinopharm have discussed in person PV-10
and its clinical results with the lead investigators at St. Buy Zenegra (Sildenafil Citrate) without prescription Luke s
University Hospital and Health Network and Moffitt Cancer Center.
Dr. Buy Dexona with no prescription Zhidan Jia , Chief Executive Officer of Sinopharm A-THINK, stated,
"We continue to work closely with Provectus to arrive at an agreement
which defines the terms of our collaboration in bringing PV-10 to the
Chinese Market. Buy Vibramycin (Doxycycline) with no prescription We hope to come to terms in the near future.”
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing oncology
and dermatology therapies. Buy Styling Gel - Mousse online PV-10, its novel investigational drug for
cancer, is designed for injection into solid tumors (intralesional
administration), thereby reducing potential for systemic side effects. http://allergy-opinion.blogspot.com
Its oncology focus is on melanoma, breast cancer and cancers of the
liver. The Company has received orphan drug designations from the FDA
for its melanoma and hepatocellular carcinoma indications. PH-10, its
topical investigational drug for dermatology, is undergoing clinical
testing for psoriasis and atopic dermatitis. Provectus has completed
phase 2 trials of PV-10 as a therapy for metastatic melanoma, and of
PH-10 as a topical treatment for atopic dermatitis and psoriasis.
Information about these and the Company’s other clinical trials,
including its current phase 3 study in melanoma, can be found at the NIH
registry, .clinicaltrials.gov.
For additional information about Provectus, please visit the Company’s
website at .pvct.com
or contact Porter, LeVay & Rose, Inc.
FORWARD-LOOKING STATEMENTS: This release contains "forward-looking
statements" as defined under U.S. federal securities laws. These
statements reflect management s current knowledge, assumptions, beliefs,
estimates, and expectations and express management s current views of
future performance, results, and trends and may be identified by their
use of terms such as "anticipate," "believe," "could," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "will," and
other similar terms. Forward-looking statements are subject to a number
of risks and uncertainties that could cause our actual results to
materially differ from those described in the forward-looking
statements. Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date hereof, and we
undertake no obligation to update such statements after this date.
Risks and uncertainties that could cause our actual results to
materially differ from those described in forward-looking statements
include those discussed in our filings with the Securities and Exchange
Commission (including those described in Item 1A of our Annual Report on
Form 10-K for the year ended December 31, 2014) and the following:
our determination, based on guidance from the FDA, whether to proceed
with or without a partner with the fully enrolled phase 3 trial of
PV-10 to treat locally advanced cutaneous melanoma and the costs
associated with such a trial if it is necessary to complete (versus
interim data alone);
our determination whether to license PV-10, our melanoma drug product
candidate, and other solid tumors such as cancers of the liver, if
such licensure is appropriate considering the timing and structure of
such a license, or to commercialize PV-10 on our own to treat melanoma
and other solid tumors such as cancers of the liver;
our ability to license our dermatology drug product candidate, PH-10,
on the basis of our phase 2 atopic dermatitis and psoriasis results,
which are in the process of being further developed in conjunction
with mechanism of action studies; and
our ability to raise additional capital if we determine to
commercialize PV-10 and/or PH-10 on our own, although our expectation
is to be acquired by a prospective pharmaceutical or biotech concern
prior to commercialization.
Wednesday, July 15, 2015
2015 European Markets for Hyaluronic Acid Viscosupplementation - Analysis & Forecasts 2011-2021
DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/v8bcrd/europe_markets)
has announced the addition of the "Europe
Markets for Hyaluronic Acid Viscosupplementation 2011-2021"
report to their offering.
Hyaluronic acid (HA) is an anionic, nonsulfated glycosaminoglycan that
is naturally present in the human body. Grifulvin (Griseofulvin) with no Rx It is mainly concentrated in
fluids in the joints. Buy Oxytrol (Oxybutynin) with free Rx Its function is to provide cushioning for joints.
Individuals who suffer from osteoarthritis are deficient in these
fluids. Levitra (Vardenafil) without Rx One of the treatment options for these patients is HA
viscosupplementation injections.
Much like the BGS market, the HA market has been experiencing price
erosion due to an increase in competition, especially in the German
market; the price for a five-injection product in Germany had been
reduced to a mere 60 for all five syringes. Dermovate with no Rx ASPs for all three cycle
products are expected to decline mildly over the forecast period.
Key Topics Covered:
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1.1 Research Scope
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2.1 Introduction
2.2 Germany
2.3 France
2.4 United Kingdom
2.5 Italy
2.6 Spain
2.7 Benelux
2.8 Scandinavia
2.9 Austria
2.10 Switzerland
2.11 Portugal
3. http://asthmareview.wordpress.com Hyaluronic Acid Viscosupplementation Market
3.1 Introduction
3.2 Market Overview
3.3 Market Analysis And Forecast
3.3.1 Total Hyaluronic Acid Viscosupplementation Market
3.3.2 Single-Injection Market
3.3.3 Three-Injection Market
3.3.4 Five-Injection Market
3.4 Drivers And Limiters
3.4.1 Market Drivers
3.4.2 Market Limiters
3.5 Competitive Analysis
Companies Mentioned
- Croma-Pharma
- Fidia
- Laboratoire Genevrier
- Meda Pharma
- Recordati
- Sanofi
- Seikagaku
- Smith & Nephew
- TRB Chemedica
- Tedec Meiji
For more information visit .researchandmarkets.com/research/v8bcrd/europe_markets
Tuesday, July 14, 2015
Moderate Psoriasis - Pipeline Insights 2015
. Anacin (Aspirin/Caffeine) with free prescription DUBLIN--(BUSINESS WIRE)--Research and Markets (.researchandmarkets.com/research/w49rlw/moderate)
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Moderate Psoriasis Pipeline Insights provides the in-depth analysis of
the pipeline assets across the Moderate Psoriasis. Buy Protein Foods online Deltasone (Prednisolone) without Rx The main objective of
this report to track competitor pipeline molecules, related research
activities, technology, collaborations, in-licensing and out-licensing
deals. http://medicalhelper.wordpress.com Savella (Milnacipran) with no Rx The Moderate Psoriasis Report helps to identify emerging players
with potentially strong product information and create effective
counter-strategies to gain competitive advantage.
Moderate Psoriasis Pipeline Insights Report covers the Moderate
Psoriasis pipeline molecules at various stages of development like
Pre-registration phase, clinical phases (Phase III, Phase II & Phase I),
pre-clinical and discovery phases. Buy Baclofen () The Report also provides Moderate
Psoriasis related therapeutic assessments by molecule type, route of
administration, monotherapy and combination products. About Cytotam without prescription The Report also
highlights the discontinued and inactive projects in pipeline for
Moderate Psoriasis.
Scope
- The report provides a Moderate Psoriasis Landscape across the globe
- The report provides drug profiles which includes product description,
MOA, licensors & collaborators, technology, development partner and
chemical information
- Coverage of the Moderate Psoriasis pipeline on the basis of target,
MOA, route of administration, technology involved and molecule type
- The report reviews key players involved in the therapeutics
development for Moderate Psoriasis and also provide company profiling
- Pipeline products coverage based on various stages of development from
NDA filings to discovery.
- Provides pipeline assessment by monotherapy and combination therapy
products, stage of development and molecule type
For more information visit .researchandmarkets.com/research/w49rlw/moderate
Monday, July 13, 2015
CDC Americans not eating enough fruits and vegetables
A new report reveals that Americans are not meeting national recommendations for
consumption of fruits and vegetables.
Eating more fruits and vegetables reduces risk of heart disease, stroke and some cancers.
The Centers for Disease Control and Prevention (CDC) analysis concludes that only
13.1% of American adults eat enough fruits and only 8.9% eat enough vegetables.
The analysis uses the most recent national survey of median daily frequency of fruit and
vegetable intake and shows that states varied widely in their consumption.
California ranks highest in consumption of both fruits (17.7% of adults) and
vegetables (13%), while at the bottom of the list are Tennessee for fruit consumption (7.5%)
and Mississippi for vegetable consumption (5.5%).
Eating more fruits and vegetables increases intake of essential nutrients and reduces the
risk for heart disease, stroke and some cancers. Deltasone (Prednisolone) without Rx Fruits and vegetables also help manage body
weight when eaten instead of more energy-dense foods, note the report authors, Dr. Savella (Milnacipran) with no Rx Latetia
V. Buy Baclofen () Moore, of the CDC, and Dr. About Cytotam without prescription Frances E. Anacin (Aspirin/Caffeine) with free prescription Thompson, of the National Cancer Institute.
For their analysis, the authors used data for 2013 from the Behavioral Risk Factor
Surveillance System (BRFSS). Buy Protein Foods online The BRFSS - which in 2013 covered 373,580 respondents - is an
ongoing, state-based telephone survey of US adults that collects data on a number of health-related areas, including food and disease.
The survey asks people questions about the types of fruits and vegetables they eat and how
frequently they eat them. http://medicalhelper.wordpress.com The categories include: 100% fruit juice, whole fruit, dried beans,
dark green vegetables, orange vegetable and other vegetables.
The authors compared the responses to the nationally recommended guidelines which state that
adults who engage in less than 30 minutes of moderate physical activity daily should consume
1.5-2.0 cup equivalents of fruit and 2-3 cups of vegetables daily. (Adults who are more
physically active may be able to consume more to match their increased calorie needs.)
Substantial new efforts are needed
Because of changes to how the survey was done and the types of questions it asks, it is
not possible to compare the results with those of previous years, say the report authors.
They note that during 2007-10, half of the US population consumed under 1 cup of fruits
and under 1.5 cups of vegetables a day: 76% did not meet recommendations for fruit intake,
and 87% did not meet vegetable intake recommendations.
The impression is that Americans appear to be stuck at a low level of fruit and vegetable
consumption as the report concludes:
"Substantial new efforts are needed to build consumer demand for fruits and
vegetables through competitive pricing, placement and promotion in child care, schools,
grocery stores, communities and worksites."
The American Heart Association
include the following among their tips for increasing daily intake of fruits and
vegetables:
Fill at least half your plate with fruits and vegetables
All produce counts: canned, dried, fresh and frozen
Compare food labels on canned, dried and frozen fruits and vegetables and choose the
lowest sodium and added sugar content
Add a fruit or vegetable salad to lunch or dinner
Eat raw vegetable sticks instead of chips
Carry dried fruit, such as raisins, dates or dried apricots for snacks
Add chopped vegetables like onions, garlic and celery when preparing soup, stew, beans,
rice and sauces
Medical News Today recently reported on a study from the CDC published in the journal
Circulation that finds sugary drink consumption
may be responsible for more than 184,000 adult deaths worldwide each year. The study defines
sugary drinks as sugar-sweetened sodas, sports and energy drinks, fruit drinks (but not 100%
fruit juices), sweetened ice teas and homemade sugary drinks.
Written by Catharine Paddock PhD
Sunday, July 12, 2015
New chemotherapy light technique discovered
Researchers have successfully pioneered a new technique that utilizes light to active chemotherapy drugs in specific cells, increasing the effectiveness of cancer therapies. About Colofac (Mebeverine) with free Rx The team describes its findings in the journal Cell.
Cancer cells can now be specifically targeted by light. Strattera (Atomoxetine) with free Rx Image credit: Malgorzata Borowiak, LMU Munich
The research co-authored by Oliver Thorn-Seshold, PhD, and Prof. About Cystone () Dirk Trauner, both from the Ludwig-Maximilians-Universitat, Munich, Germany. Cyclandelate without prescription They sought to solve the problem of the severe side effects experienced by some users of widely prescribed chemotherapeutic drugs.
There are currently over 100 types of cancer currently identified, each classified by the cell that is affected. Ashwafera () with free Rx Different types of cancer very rarely behave similarly, hence the huge challenge facing patients and health care professionals to identify the best treatment. Buy PMS online
Traditionally, chemotherapy drugs do not specifically target cancer cells, and so intersect with the function of normal cells, causing severe side effects such as heart and nerve damage. http://medical-reviews.blogspot.com Due to this risk, the treatment can only be administered in relatively low doses and does not provide the best therapeutic benefit.
To overcome this challenge, scientists developed a method for optically controlling microtubule inhibitor drugs that are currently in clinical trials. Inhibitors interfere with the function of microtubules, components of the cell s skeleton that play a key role in cell proliferation, migration and survival.
Researchers identified a fixed structural element required for a drug s biological activity and replaced this element with a flexible hinge that can swing open or shut in response to blue light.
Prof. Trauner describes the advantage of the technique:
"The upshot is that our compounds retain the powerful anticancer effects of existing microtubule inhibitors but add the bonus of tissue-specific localization."
The modified compounds, called "photostatins," are effective at inhibiting the proliferation and survival of cells targeted by light, but neighboring cells are unaffected. This technique can be used numerous times, making it suitable for long-term applications in both the clinic and lab.
The new development also opens the door for further research because the technique targets a critical microtubule subunit located in the cells of all plants and animals. This method may be adapted to study or treat a broad range of organisms or processes, or even potentially a broad range of diseases in humans.
Truly therapeutic
Dr. Thorn-Seshold hopes the elimination of the unwanted side effects ensures "the new compounds will be able to be used in medicine at dosages that are truly therapeutic in tumors, thus achieving a much more effective therapy than currently possible."
In future clinical settings, scientists hope the technique can treat a range of conditions. Eye cancer patients can be treated wearing blue-tinted glasses and skin cancer with a bandage that delivers light. An implantable network of tiny LEDs that blink every few minutes to maintain the chemotherapeutic effect can be used for internal tumors.
Dr. Thorn-Seshold hopes the results will be an important step in the development of cancer treatment, he said:
"The field of photopharmacology is very young, so it may take some time for the pharmaceutical industry to recognize the value of compounds. Yet if our ongoing studies are successful, we will have a convincing proposition for further preclinical development, and we are committed to getting as far into real therapy as we can."
Written by Peter Lam
Saturday, July 11, 2015
Tours of Iraq and Afghanistan highlight those soldiers at highest suicide risk
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Researchers have analyzed data from 9,791 Army personnel who attempted suicide during the wars in Afghanistan and Iraq, identifying risk factors for enlisted soldiers and officers.
Officer ranks in the Army were at much lower risk for suicide than regular enlisted soldiers.
According to the study in JAMA Psychiatry, from 2004 through 2009, the Army experienced the longest sustained increase in suicide rates relative to the other US military branches (Navy, Marines and Air Force). Atrovent (Ipratropium Bromide) without Rx Nonfatal attempts rose sharply in line with an increase in fatal attempts.
Dr. Viagra Super Active (Sildenafil Citrate) with no prescription Robert Ursano, of the Uniformed Services University of the Health Sciences in Bethesda, MD, and coauthors identified risk factors among the data. Buy Serevent (Salmeterol) Enlisted soldiers had higher odds for a suicide attempt if they were:
Female
Had entered the Army at age 25 years or older
Were currently 29 years old or younger
Had not completed high school
Were in their first 4 years of service
Had a mental health diagnosis during the previous month.
The research finds that female enlisted soldiers are more than twice as likely as male enlisted soldiers to attempt suicide in spite of accounting for only 13.7% of the active-duty regular Army - so may be considered for risk assessment interventions, say the authors.
The researchers estimates showed that soldiers were more likely to get into a suicidal state than their managing officers.
Enlisted women had nearly 13 times the risk of female officers for a suicide attempt; and enlisted soldiers who entered the Army at 25 years or older had more than 16 times the risk of officers in the same age group.
The authors conclude:
"Enlisted soldiers in their first tour of duty account for most medically documented suicide attempts. About Colazal without Rx Risk is particularly high among soldiers with a recent mental health diagnosis.
A concentration of risk strategy that incorporates factors such as sex, rank, age, length of service, deployment status and mental health diagnosis into targeted prevention programs may have the greatest effect on population health within the US Army."
Dr. About Cephalexin (Cephalexin) with no Rx Ursano and team used data on documented suicide attempts in active-duty US Army members during the wars in Afghanistan and Iraq from the Army Study to Assess Risk and Resilience in Service members (Army STARRS).
Higher ranks at lower risk
While enlisted soldiers constituted 83.5% of active-duty regular Army soldiers, they accounted for almost all cases of suicide attempt (98.6%, or 9,650 cases).
This equated to an overall rate of 377 per 100,000 person-years during the study period.
Officer ranks (both commissioned and warrant) accounted for 16.5% of the regular Army but only 1.4% of suicide attempts (141 cases), equating to an overall rate of 27.9 per 100,000 person-years.
The peak time for suicide risk in enlisted soldiers was the second month of duty, after which the risk fell as length of service increased. Buy Natural Household Cleaners online
The groups showing lower likelihood of a suicide attempt were:
Black, Hispanic or Asian race or ethnicity
Currently deployed enlisted soldiers (as compared with other enlisted soldiers).
The study authors make this recommendation:
"Future studies should examine suicide attempt risk in the context of other military characteristics (for example, military occupational specialty, number of previous deployments, history of promotion and demotion) and mental health indicators (for example, number and types of psychiatric diagnoses, treatment history)."
Written by Markus MacGill
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