Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
Dateline City:
KENILWORTH, N.J. Marketing Authorization Application to the European Medicines Agency Currently Under ReviewKENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the New Drug Application (NDA) for MK-1293, an
investigational follow-on biologic1 insulin glargine
candidate for the treatment of people with type 1 and type 2 diabetes,
which is being developed by Merck with partial funding from Samsung
Bioepis.Language:
Engl...
Source: Merck.com - Research and Development News - August 5, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK Glargine MSD Source Type: news
Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine
KENILWORTH, N.J.--(BUSINESS WIRE), August 5, 2016 --Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 5, 2016 Category: Drugs & Pharmacology Source Type: news
CVS Drops Sanofi's Diabetes Drugs for Biosimilars CVS Drops Sanofi's Diabetes Drugs for Biosimilars
U.S. pharmacy benefit manager CVS will drop Sanofi ' s main insulin drug Lantus from the list of medicines it reimburses on behalf of health insurers, dealing a blow to the French drugmaker ' s key diabetes business.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 4, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Lantus (Insulin Glargine [rDNA origin] Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - August 1, 2016 Category: Drugs & Pharmacology Source Type: news
Merck Results Underscore Need To Go Big Or Go Home In Diabetes Market
Looking at the earnings posted by Merck & amp; Co. (MRK), I could not help but compare and contrast them with what Sanofi (SNY) said this morning. Like Sanofi had with Lantus, Merck has a mega-blockbuster with Januvia. Just as Lantus was getting long in the tooth and facing patent expiration so too is Januvia. The main difference is how each company planned for life beyond their respective mega-blockbusters. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - July 29, 2016 Category: Pharmaceuticals Authors: David Kliff Source Type: news
EASD: Additional Evidence Showed ABASAGLAR (insulin glargine) Provided Safety and Efficacy Similar to Lantus
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
Eli Lilly and Company and Boehringer Ingelheim announce regulatory submission for new insulin glargine biosimilar product
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
Eli Lilly and Company and Boehringer Ingelheim announce new drug application filing in the U.S. for new insulin glargine product
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
Studies Show Investigational New Insulin Glargine Product from Lilly and Boehringer Ingelheim Similar in Safety and Efficacy to Lantus
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
CHMP Recommends Lilly and Boehringer Ingelheim ’s New Insulin Glargine Product for Approval in the European Union
(Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe
European Commission grants Lilly and Boehringer Ingelheim ' s insulin glargine product marketing authorisation in Europe (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - July 25, 2016 Category: Research Source Type: news
Five diabetes drugs in top-10 selling list; overtakes anti-infective, antibiotic meds
Insulin brand Human Mixtard, oral formulation Glycomet GP, insulin Lantus, oral formulations Galvus Met and Janumet are now in the top-selling list of drugs in the country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2016 Category: Pharmaceuticals Source Type: news
Biocon's partner firm launches diabetes product in Japan
In March this year, Biocon received approval from the Japanese health authority to sell its biosimilar product Insulin Glargine. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 15, 2016 Category: Pharmaceuticals Source Type: news
Newer insulin glargine formula curbs nocturnal hypoglycemia
NEW ORLEANS – Insulin glargine 300 U/mL provided comparable glycemic control to that seen with insulin glargine 100 U/mL and consistently reduced the risk of nocturnal hypoglycemia in patients with... (Source: Clinical Endocrinology News)
Source: Clinical Endocrinology News - July 13, 2016 Category: Endocrinology Source Type: news
Biosimilar Insulin Glargine Matches Up With Lantus in Phase III
(MedPage Today) -- Merck's copycat has similar HbA1c effect in trial (Source: MedPage Today Meeting Coverage)
Source: MedPage Today Meeting Coverage - June 14, 2016 Category: Journals (General) Source Type: news
