FDA Staff Supports Celltrion's Biosimilar RemicadeFDA Staff Supports Celltrion's Biosimilar Remicade
U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc's biosimilar form of blockbuster arthritis drug Remicade indicated it is "highly similar" to the branded product in terms of safety, purity and potency. Reuters Health Information (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - February 8, 2016 Category: Orthopaedics Tags: Rheumatology News Source Type: news
FDA Staff Gives Infliximab Biosimilar Rave Review
(MedPage Today) -- Advisory committee to review the agent this week (Source: MedPage Today Rheumatology)
Source: MedPage Today Rheumatology - February 8, 2016 Category: Rheumatology Source Type: news
FDA staff backs biosimilar to Remicade; J&J and AbbVie fall
(Reuters) - U.S. Food and Drug Administration staff members on Friday said Celltrion Inc's biosimilar form of Johnson & Johnson's Remicade arthritis drug appeared "highly similar" to the widely used branded product. (Source: Reuters: Health)
Source: Reuters: Health - February 5, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
FDA reviewers support Celltrion's biosimilar Remicade
(Reuters) - U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc's biosimilar form of blockbuster arthritis drug Remicade indicated it is "highly similar" to the branded product in terms of safety, purity and potency. (Source: Reuters: Health)
Source: Reuters: Health - February 5, 2016 Category: Consumer Health News Tags: healthNews Source Type: news
Remicade® developer funds new super-resolution microscope at Scripps Florida
(Scripps Research Institute) The co-developer of Remicade®, one of the three top-selling drugs in the world, has donated more than $500,000 to fund what will be known as the Iris and Junming Le Foundation Super-Resolution Microscopy Facility on the Florida campus of the Scripps Research Institute. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 29, 2016 Category: Global & Universal Source Type: news
Biosimilar of Remicade Works in Ankylosing Spondylitis (CME/CE)
(MedPage Today) -- No differences in immunogenicity were observed, authors say (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - January 27, 2016 Category: Geriatrics Source Type: news
Review Shows Varying Safety of Rheum Biologics (CME/CE)
(MedPage Today) -- Results generally favor Orencia and others over Remicade in autoimmune disorders (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - December 23, 2015 Category: Geriatrics Source Type: news
Infliximab-Associated Hepatic Failure in Ulcerative ColitisInfliximab-Associated Hepatic Failure in Ulcerative Colitis
While a rare occurrence, this report calls attention to a potentially lethal adverse effect of infliximab, underscoring the need to rule out pre-existing liver disease before initiating IFX therapy. Journal of Medical Case Reports (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 11, 2015 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news
An Update on BiosimilarsAn Update on Biosimilars
Biosimilars to adalimumab, etanercept, and infliximab measure up safety and efficacy-wise for rheumatology patients inadequately responsive to methotrexate. Medscape Rheumatology (Source: Medscape Rheumatology Headlines)
Source: Medscape Rheumatology Headlines - December 9, 2015 Category: Rheumatology Tags: Rheumatology Commentary Source Type: news
Infliximab Dose Doubling in Patients With Ulcerative ColitisInfliximab Dose Doubling in Patients With Ulcerative Colitis
What does the latest research tell us about the efficacy and safety of infliximab dose doubling in ulcerative colitis patients with a loss of response to infliximab? Alimentary Pharmacology & Therapeutics (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 9, 2015 Category: Consumer Health News Tags: Gastroenterology Journal Article Source Type: news
Merck Announces Samsung Bioepis Receives Approval of RENFLEXIS™ (Infliximab), a Biosimilar of Remicade, in Korea
Dateline City:
KENILWORTH, N.J.
Samsung Bioepis’ Second Immunology Biosimilar Approved, to be Commercialized Under Partnership with Merck
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that Samsung Bioepis Co., Ltd. has received approval of
RENFLEXIS™ (infliximab), a biosimilar of the immunology medicine
Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. Merck
will commerc...
Source: Merck.com - Corporate News - December 7, 2015 Category: Pharmaceuticals Tags: Corporate News Latest News #Merck #MRK $MRK biosimilar NYSE:MRK RENFLEXIS Source Type: news
On-Demand Doses of Infliximab in Ankylosing SpondylitisOn-Demand Doses of Infliximab in Ankylosing Spondylitis
Would ankylosing spondylitis patients benefit from a treatment regimen of on-demand maintenance dosing with infliximab? Journal of Clinical Rheumatology (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - December 2, 2015 Category: Orthopaedics Tags: Rheumatology Journal Article Source Type: news
EPIRUS Biopharmaceuticals Provides Clinical Program Update on BOW015 (Infliximab Biosimilar)
(Source: Medical News (via PRIMEZONE))
Source: Medical News (via PRIMEZONE) - November 16, 2015 Category: Pharmaceuticals Source Type: news
Merck Announces Samsung Bioepis Will Present New Biosimilars Data at the 2015 ACR/ARHP Annual Meeting
Dateline City:
KENILWORTH, N.J.
One-Year Phase 3 Data for Investigational Biosimilar Candidates SB4, Enbrel (Etanercept) and SB2, Remicade (Infliximab) to be Presented for the First Time
New Pivotal 24-Week Phase 3 Data for SB5, an Investigational Biosimilar of Humira (Adalimumab), to be Reported in Late-Breaking Presentation
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that Sam...
Source: Merck.com - Research and Development News - November 5, 2015 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news
Remicade price reduction in UK
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - November 1, 2015 Category: Drugs & Pharmacology Source Type: news
