FDA clears Sanofi's follow-on diabetes biologic of Lilly's Humalog
(Reuters) - The U.S. Food and Drug Administration said on Monday it approved Sanofi SA's Admelog as the first follow-on biologic version of Eli Lilly and Co's fast-acting insulin, Humalog. (Source: Reuters: Health)
Source: Reuters: Health - December 11, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA approves Admelog, the first short-acting " follow-on " insulin product to treat diabetes
The FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 11, 2017 Category: American Health Source Type: news
New Diabetes Drug, Admelog (Insulin Lispro), Gets FDA OK Under'Abbreviated' Pathway
MONDAY, Dec. 11, 2017 -- Admelog (insulin lispro), a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat people with either type of diabetes, for patients aged three years and older.
It ' s the first drug... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 11, 2017 Category: General Medicine Source Type: news
Eli Lilly ’ s Humalog Junior KwikPen diabetes drug-device combo launches in U.S.
Eli Lilly‘s (NYSE:LLY) Humalog Junior KwikPen insulin lispro injection is available in the U.S. by prescription for people with diabetes, the company said today.
The drug-device combination product is designed as a pre-filled, disposable half-unit insulin pen.
Get the full story at our sister site, Drug Delivery Business News.
The post Eli Lilly’s Humalog Junior KwikPen diabetes drug-device combo launches in U.S. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - October 4, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat Eli Lilly & Co. Source Type: news
Sanofi wins tentative FDA nod for Admelog insulin lispro injection
Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection.
The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, Sanofi said.
Get the full story at our sister site, Drug Delivery Business News.
The post Sanofi wins tentative FDA nod for Admelog insulin lispro injection appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - September 1, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Sanofi-Aventis Source Type: news
Sanofi Receives Tentative FDA Approval of Admelog (insulin lispro injection) 100 units/mL
BRIDGEWATER, N.J., Sept. 1, 2017 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog ® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2017 Category: Drugs & Pharmacology Source Type: news
Biosimilar insulin lispro shown not inferior to Humalog ® in efficacy or safety
(Mary Ann Liebert, Inc./Genetic Engineering News) A study comparing the safety and efficacy of SAR342434, a biosimilar (follow-on form) of insulin lispro-Humalog ® , found it to be comparable to that of the brand name drug in patients also using insulin glargine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 9, 2017 Category: International Medicine & Public Health Source Type: news
Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device
Eli Lilly (NYSE:LLY) said today that the FDA approved its Humalog Junior KwikPen for the treatment of diabetes.
The device is a pre-filled pen with half-unit dosing capabilities, which Eli Lilly said gives patients access to finer dose adjustment.
Get the full story at our sister site, Drug Delivery Business News.
The post Lilly wins FDA nod for Humalog pre-filled Junior KwikPen device appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - June 14, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Eli Lilly & Co. Source Type: news
European Medicines Agency Backs Biosimilar Insulin Lispro European Medicines Agency Backs Biosimilar Insulin Lispro
The positive opinion is for a biosimilar of bolus insulin for use at mealtimes and in insulin pumps.International Approvals (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - May 22, 2017 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news
Sanofi ’s insulin lispro receives CHMP positive opinion to treat diabetes
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Sanofi's insulin lispro. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news
Sanofi ’ s insulin biosimilar wins EMA committee recommendation
Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval.
Insulin lispro Sanofi is a biosimilar of insulin lispro, a fast-acting insulin analog made using recombinant DNA technology. Sanofi’s biosimilar has the exact same amino acid sequence as its reference product. The positive opinion from CHMP is Sanofi’s 1st major regulatory win for a biosimilar diabetes treatment.
Get the full story at our sister site, Drug Delivery Business News.
The post Sanofi’s insulin biosimilar wins EMA committee recommen...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Wall Street Beat Sanofi-Aventis Source Type: news
Sanofi Receives CHMP Recommendation for Approval of Insulin Lispro Biosimilar
Positive opinion based on a clinical development program involving over 1,000 people with type 1 or type 2 diabetes
Paris, France - May 19, 2017 - Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medi... Biopharmaceuticals, Regulatory Sanofi, Insulin lispro, Biosimilar (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 19, 2017 Category: Pharmaceuticals Source Type: news
Eli Lilly ’ s diabetes drugs boost Q1 revenue, earnings
Shares in Eli Lilly (NYSE:LLY) fell slightly today as the company met expectations on Wall Street with its 1st quarter financial results.
The company has faced its share of issues in the last year – Lilly took a $150 million hit in November after its Alzheimer’s drug failed in a clinical trial and this month, the FDA rejected its rheumatoid arthritis drug. But the company’s diabetes therapies, such as Trulicity and Humalog, helped to propel the company to an adjusted quarterly profit that beat expectations on The Street.
“We are encouraged by another solid performance from Lilly’s overall di...
Source: Mass Device - April 25, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes MassDevice Earnings Roundup Pharmaceuticals Wall Street Beat Eli Lilly & Co. Source Type: news
Humalog Mix 50-50 (Insulin Lispro) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 17, 2017 Category: Drugs & Pharmacology Source Type: news
Eli Lilly gets FDA clearance for insulin dose calculator app
Indianapolis-based pharma company Eli Lilly recently recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly ' s rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. (Source: mobihealthnews)
Source: mobihealthnews - January 19, 2017 Category: Information Technology Source Type: news
