Navigation Links
Coherus anuncia que CHS-1420 cumple con los objetivos primarios en el ensayo clínico farmacocinética pivote
Date:8/15/2014

REDWOOD CITY, California, 15 de agosto de 2014 /PRNewswire/ -- Coherus BioSciences, Inc. ("Coherus") anunció hoy que CHS-1420, su biosimilar propuesto de adalimumab (Humira®), cumple con el objetivo primario dentro del estudio de similitud farmacocinética pivote clínica (PK) que compara CHS-1420 con Humira® en pacientes sanos. El estudio de una sola dosis y grupo paralelo cumple con el criterio para toda la similitud clínica PK en los tres objetivos PK necesarios de definición prospectiva: concentración máxima de suero (Cmax), curva de área bajo concentración de tiempo del primer al último punto evaluado (AUC0-t) y curva de área bajo concentración de tiempo del primer al último punto extrapolado para infinito (AUC0-inf), con las tres medias geométricas dentro del 90% del intervalo de confianza pasando del 80% al 125%. Ambos agentes fueron tolerados correctamente y no se produjeron descubrimientos de seguridad diferenciales observados entre los dos agentes dentro de este estudio.

Logo - http://photos.prnewswire.com/prnh/20120507/SF01448LOGO

"Un requisito global normativo esencial es la finalización de un estudio clínico que compara de forma directa el originador y nuestro candidato biosimilar creando una similitud PK", explicó Barbara Finck, doctora y responsable médico de Coherus. "Estamos encantados de haber conseguido resultados robustos que creemos representan una reducción importante en el desarrollo de riesgos dentro del programa".

"Adalimumab es una molécula muy compleja. Conseguir este logro científico valida la plataforma de desarrollo de Coherus y demuestra nuestra capacidad para avanzar dentro de los biosimilares en nuestra cartera", indicó

SOURCE Coherus BioSciences
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Coherus Announces CHS-0214 (Proposed Etanercept Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study
2. Coherus anuncia que CHS-0214 (biosimilar etanercept propuesto) supera punto final primario en decisivo estudio clínico farmacocinético
3. Coherus Biosciences als Präsentator zur J.P. Morgan Annual Healthcare Conference 2014 eingeladen
4. Coherus Biosciences Invited to Present at 2014 J.P. Morgan Annual Healthcare Conference
5. Coherus Announces Initiation Of Phase 3 Trial Of CHS-0214 (Investigational Etanercept Biosimilar) In Chronic Plaque Psoriasis (RaPsOdy)
6. Coherus anuncia início do estudo Fase 3 do CHS-0214 (Biossimilar Investigativo do Etanercept) em psoríase crônica em placas (RaPsOdy)
7. Coherus Announces CHS-1420 (Investigational Adalimumab Biosimilar) Meets Primary Endpoint In Pivotal Pharmacokinetic Clinical Study
8. L.S.E. (Barcelona) anuncia la primera financiación del antiplaquetario NmC por inversores españoles y suizos
9. RPS anuncia a Jonathan M. Fishbein, MD, como vicepresidente ejecutivo y jefe médico
10. RPS anuncia Jonathan M. Fishbein, MD como vice-presidente executivo e diretor médico
11. GenScript Anuncia Exposição Itinerante Junto com a Open Monoclonal Technology, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... , Dec. 15, 2014  The Government of Ghana ... AABB, Global Blood Fund (GBF) and Terumo BCT to respond to ... as well as provide long-term health system capacity to the citizens ... , The Ghanaian Ebola Readiness and Resilience Initiative (GERRI) is ... preparations for the possible arrival of the Ebola epidemic ...
(Date:12/14/2014)... , Dec. 14, 2014  ChartSpan, a consumer ... most downloaded iPhone and iPad medical app in ... - http://photos.prnewswire.com/prnh/20141214/164317 ChartSpan is ... ability to request, manage and send electronic healthcare records. ... entrepreneurs who grew tired of waiting for the healthcare ...
(Date:12/13/2014)... 2014 Research and ... of the  "Global Catheters Market (Product Types ... Company Profiles, Analysis, Segmentation and Forecast, 2013 ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , , ... medical grade material such as plastic, silicon ...
Breaking Medicine Technology:Government of Ghana Endorses Collaboration to Combat Ebola Epidemic 2Government of Ghana Endorses Collaboration to Combat Ebola Epidemic 3Government of Ghana Endorses Collaboration to Combat Ebola Epidemic 4Government of Ghana Endorses Collaboration to Combat Ebola Epidemic 5Government of Ghana Endorses Collaboration to Combat Ebola Epidemic 6ChartSpan Becomes The Most Downloaded Medical App in America 2ChartSpan Becomes The Most Downloaded Medical App in America 3Global Catheters Market (Product Types and Geography) - Forecast to 2020 2Global Catheters Market (Product Types and Geography) - Forecast to 2020 3
(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... MTBC also launches the PDA version of its ... MTBC, the unique revenue cycle,and practice management ... for patients with United Healthcare insurance.,MTBC believes it ... this,breakthrough with any insurer., RTA provides an ...
... very nature, skin of color is,considered sensitive skin by ... of skin problems. Acne and rosacea,can be especially problematic ... skin irritation in these patients can cause pigmentation,problems that ... skin., At the American Academy of Dermatology,s Summer ...
... Cord Blood, DETROIT, July 30 The Barbara ... multi-year grant,from the J.P. McCarthy Fund of the Community ... Stem Cell Bank. The grant, which,will be given in ... area and expand the capacity to help people in ...
... someday replace the invasive, uncomfortable endoscope now used ... esophagus. , Steven J. Ackerman of University of ... Glenn T. Furuta, his colleague at the University ... for an all-fronts attack on eosinophilic esophagitis, an ...
... Ltd. (Amex: CPD ) announced today, that ... behalf of Sun Pharmaceutical,Industries Ltd. (Sun Pharma). Sun ... Drug Administration (FDA) for its Abbreviated New Drug,Application ... Divalproex sodium delayed release tablets are indicated as ...
... FOX, ABC, NBC ... and CBS, ... the adventures of parenting, announced that "Viva la,Familia! de Todobebe" (Hooray for ... Friday night July 25th in Prime,Time delivering 3.3 million viewers 2+ and ...
Cached Medicine News:Health News:MTBC First Medical Billing Company in the U.S. To Offer Automated Real-time Adjudication of Claims 2Health News:American Academy of Dermatology: Acne and Rosacea Got You Seeing Red? Patients with Skin of Color Advised to Seek Proper Diagnosis, Treatment to Prevent Common Side Effects 2Health News:American Academy of Dermatology: Acne and Rosacea Got You Seeing Red? Patients with Skin of Color Advised to Seek Proper Diagnosis, Treatment to Prevent Common Side Effects 3Health News:American Academy of Dermatology: Acne and Rosacea Got You Seeing Red? Patients with Skin of Color Advised to Seek Proper Diagnosis, Treatment to Prevent Common Side Effects 4Health News:J.P. McCarthy Fund Grants $250,000 to Karmanos Cancer Institute 2Health News:J.P. McCarthy Fund Grants $250,000 to Karmanos Cancer Institute 3Health News:J.P. McCarthy Fund Grants $250,000 to Karmanos Cancer Institute 4Health News:String probes for devastating childhood digestive disease 2Health News:Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets 2Health News:Todobebe's New Family TV Show Debuts as #1 Show in the U.S. Among All Adults 18 to 34 2
... information to facilitate diagnostic accuracy for appropriate ... sterile, disposable device used to inject fluid ... procedures. The device will measure the pressure ... a digital format. The physician can control ...
Maxi-Therm® hyper-hypothermia water blankets from Cincinnati Sub-Zero are designed for single-patient use. These blankets are easy to clean, stain resistant and ideal for isolation cases....
The Neuro-Cool™ System provides pain relief by combining a head wrap with a cold therapy unit for effective migraine treatment....
The ImmunoWELL Borrelia M Test is an enzyme immunoassay (EIA) for the qualitative and/or semiquantitative detection of Borrelia burgdorferi,IgM antibodies in serum and is used as an aid in the diag...
Medicine Products: