Navigation Links
Nonclinical and Clinical Safety Assessment of Biosimilars, New Webinar Hosted by Xtalks
Date:7/15/2013

Toronto, Canada (PRWEB) July 15, 2013

The development of Biosimilars has gained momentum in recent years due to upcoming patent expiry of first generation Biologics and increasing financial pressure on health care systems. Consequently, regulatory frameworks are evolving in various countries to guide a path for Biosimilar drug development, however, the complex nature of Biopharmaceuticals makes the demonstration of Biosimilarity with regard to quality, safety and efficacy extremely challenging.

Based on the specific aspects of Biosimilar drug development and registration, the development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.

The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of Biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area.

A live Q&A with the audience will follow the main presentation. For more information, or to register for this event please go to http://xtalks.com/biosimilars-safety-assessment.ashx

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://www.xtalks.com

Contact:
Zayeeta Dasgupta, M.Sc in Life Science and Business Ma
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. PointCross Life Sciences Opens New Office in Silver Spring, Maryland for Data Standardization of Nonclinical Studies
2. ChemoCentryx Presents Positive Results for Novel CCR2 Inhibitor in Preclinical Models of Diabetic Nephropathy at the 44th Annual Meeting of the American Society of Nephrology
3. Positive Clinical Study Results for BSPs HyperQ Technology
4. DermTechs Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
5. Nile Therapeutics Announces Top-Line Results in Clinical Trial Evaluating the Subcutaneous Infusion of Cenderitide, Meets Primary Endpoint
6. AtheroNova Inc. Preclinical Study Demonstrates 95% Reduction in Arterial Plaque Formation
7. A New Type of Dendritic Cell-Based Cancer Vaccine has Received Approval for Clinical Tests and at the Same Time Secures Substantial Financing
8. Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program
9. US Oncology Research Affiliated Physician to Present Findings From Innovative Clinical Trial at 2011 CTRC-AACR San Antonio Breast Cancer Symposium
10. TetraLogic Pharmaceuticals Announces Initiation of a Phase 1/2 Clinical Trial of TL32711 in Patients with Acute Myelogenous Leukemia (AML)
11. Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony® Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 Diabetes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/16/2015)...  RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" ... with G-treeBNT (ReGenTree LLC) has retained Ora, Inc. ... the orphan disorder, neurotrophic keratopathy (NK), and a ... (DES) in the U.S.  Both trials will be ... Each of these eye disorders was being targeted ...
(Date:4/16/2015)... April 16, 2015  AnaptysBio, Inc., a leader ... antibodies, today announced the advancement of its ... IND-enabling studies. The Company,s anti-IL-36R therapeutic antibody, ... generalized pustular psoriasis (GPP), an orphan systemic ... is wholly owned within AnaptysBio,s proprietary antibody ...
(Date:4/16/2015)... Switzerland , April 16, 2015 /PRNewswire/ ... Debiopharm Group ™ , a Swiss-based global biopharmaceutical ... medical needs as well as companion diagnostics, ... investigational compounds Debio 1143 (SMAC mimetic) and Debio 1347/CH5183284 ... the 2015 Annual meeting of the American Association for Cancer Research ...
(Date:4/16/2015)... 16, 2015 Dana-Farber Cancer Institute ... and Resolution Bioscience, Inc. today announced the successful ... novel, blood-based, clinic ready, Next Generation Sequencing (NGS) ... collaboration is the first to demonstrate the successful ... fusions in blinded plasma samples and highlights the ...
Breaking Biology Technology:RegeneRx JV Retains Ora, Inc. to Conduct Phase 3 Trial for NK and Phase 2b/3 Trial for Dry Eye Syndrome in U.S. 2RegeneRx JV Retains Ora, Inc. to Conduct Phase 3 Trial for NK and Phase 2b/3 Trial for Dry Eye Syndrome in U.S. 3RegeneRx JV Retains Ora, Inc. to Conduct Phase 3 Trial for NK and Phase 2b/3 Trial for Dry Eye Syndrome in U.S. 4RegeneRx JV Retains Ora, Inc. to Conduct Phase 3 Trial for NK and Phase 2b/3 Trial for Dry Eye Syndrome in U.S. 5AnaptysBio Advances First-In-Class Anti-IL-36 Receptor Antibody Program To Treat Orphan Inflammatory Disease 2Debiopharm International SA Announces Results of 2 Key Oncology Programs at 2015 AACR Conference 2Debiopharm International SA Announces Results of 2 Key Oncology Programs at 2015 AACR Conference 3Resolution Bioscience announces successful collaboration on a novel, non-invasive, targeted NGS test for lung cancer 2Resolution Bioscience announces successful collaboration on a novel, non-invasive, targeted NGS test for lung cancer 3
... 2011 RiverVest Venture Partners®, a venture capital ... companies, today announced that John McKearn, Ph.D., has ... Dr. McKearn joined RiverVest as Venture Partner in ... pharmaceutical research and development as former president and ...
... 3, 2011 Cynosure, Inc. (NASDAQ: CYNO ) today ... Revenues for the first quarter of 2011 increased ... period of 2010.   Net loss for the first quarter of ... compared with a net loss of $2.8 million, or $0.22 per ...
... MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) today announced ... The net income for the first quarter ended ... loss of $14.1 million during the same period in 2010. ... was related primarily to the $34.2 million in collaboration revenue ...
Cached Biology Technology:John McKearn, Ph.D., Promoted to Managing Director of RiverVest Venture Partners 2Cynosure Reports Financial Results for the First Quarter of 2011 2Cynosure Reports Financial Results for the First Quarter of 2011 3Cynosure Reports Financial Results for the First Quarter of 2011 4Cynosure Reports Financial Results for the First Quarter of 2011 5Cynosure Reports Financial Results for the First Quarter of 2011 6MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 2MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 3MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 4MAP Pharmaceuticals Reports First Quarter of 2011 Financial Results 5
(Date:4/13/2015)... a leading cloud-based consumer engagement platform that provides trusted ... communities around health and wellness, announced today the launching ... The ... vehicle to receive validated health information from consumers. ... will allow higi,s trusted partners, on a user opt-in ...
(Date:4/2/2015)... , April 2, 2015 ... tests DERMALOG by far outperforms the strongest competitors, ... maintaining high accuracy, the system is capable of ... the speed proves up to be ten times ... than its runner-up performance.      (Photo: ...
(Date:4/1/2015)... , April 1, 2015   Medisafe ™, ... million users across iOS and Android ... begun integrating biofeedback into the platform to allow patients ... outcomes. For the first time, patients will be able ... a dose impacts important biometrics, such as glucose levels ...
Breaking Biology News(10 mins):higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 2DERMALOG AFIS Emerges as Performance Winner in NIST Benchmark Test 3Medisafe Announces Launch of Biometric Integration, Enabling Patients to Stay Adherent to Their Meds and See Tangible Health Results 2
... latest research discoveries on diabetes, obesity, endocrine-disrupting chemicals, adolescent health ... press conferences at ENDO 2013: The 95th Annual Meeting & ... Saturday, June 15 Adolescent Health ... used to help teens with conditions including eating disorders and ...
... 2013The Roy J. Carver Charitable Trust has awarded a ... at the University of Illinois at Urbana-Champaign. Under the ... Investigator Dr. Christopher Rao, the grant will be disbursed ... for a new research theme devoted to the new ...
... oceans absorb about 25 percent of the carbon dioxide ... they have taken up about half of the man-made ... seen with the naked eye, make this valuable service ... seawater, various species convert it to organic carbon and ...
Cached Biology News:Roy J. Carver Charitable Trust funds new research focus at Institute for Genomic Biology 2Fast-sinking jellyfish could boost the oceans' uptake of carbon dioxide 2Fast-sinking jellyfish could boost the oceans' uptake of carbon dioxide 3
... Gene Pulser Xcell microbial system, 100 ... used for electroporation of bacterial and ... main unit, PC module for exponential ... sterile cuvettes (5 each of 0.1 ...
... Array (MSTA) slides were designed to study protein ... multiple species. Tissue slices from three different ... can then be treated as a single histological ... situ hybridization. This format allows a ...
... is used to predict the ... sequence up to 3,200 bases, ... of primers and GC clamps ... gradient gel electrophoresis (DGGE), constant ...
... RNAi Services offer you a full ... studies. B-Bridges advanced design parameters, effective ... ensure that you obtain quality results ... Design Service utilizes their proprietary B-Algo ...
Biology Products: