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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

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 EM...
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 ov...
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

Eli Lilly, Express Scripts offer insulin discount program
Eli Lilly (NYSE:LLY) said it is teaming up with pharmacy benefit manager Express Scripts (NSDQ:ESRX) to offer discounts on the US pharma giant’s insulin products for uninsured patients and people with high-deductible insurance plans. The program will begin January 1, 2017 and will cover Lilly’s insulins Humalog, Humulin, and the biologic Basaglar. Lilly said it anticipates the program will provide some patients with a discount as high as 40%. Insulin drugmakers have been criticized this year for their drug pricing strategies. Sen. Bernie Sanders (I-Vermont) took to Twitter last month and wrote th...
Source: Mass Device - December 14, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Pharmaceuticals Wall Street Beat CVS Health Eli Lilly & Co. Express Scripts Novo Nordisk Source Type: news

Companion Medical wins FDA nod for InPen insulin pen
Companion Medical said today it won FDA 510(k) approval for its wireless-enabled InPen insulin pen and mobile application. The InPen is designed to connect to smartphones via bluetooth and send data back, including insulin dosage and timing, the company said. The app allows patients to track and calculate doses, and set alarms for future doses. “FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care. The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increas...
Source: Mass Device - July 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Diabetes Food & Drug Administration (FDA) Regulatory/Compliance Companion Medical Source Type: news

Mannkind taps medtech reps after Sanofi deal fails
Mannkind chief commercial officer Michael Castagna is trying to resuscitate the inhaled insulin maker after its co-marketing agreement with Sanofi (NYSE:SNY) was cancelled at the beginning of the year due to disappointing sales. He’s fielding a team of about 70 people to sell the company’s Afrezza insulin inhaler, with about ⅓ coming from the medical device industry. “We are looking to build a high energy nimble company that reflects the speed of the medical device industry, articulation of the science from biotech and a relentless focus on helping patients suffering from diabetes,” Castagna told ...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Varun Saxena Tags: Business/Financial News Diabetes Drug-Device Combinations Mannkind Corp. Sanofi-Aventis newtag Source Type: news

Humalog (Insulin Lispro (Human Analog)) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 17, 2016 Category: Drugs & Pharmacology Source Type: news

Insulet deals Neighborhood Diabetes biz to Liberty Med for $5m
Insulet (NSDQ:PODD) said today it’s selling its Neighborhood Diabetes supplies biz to mail order medical supply company Liberty Medical for $5 million in cash, $58 million less than the company paid for it in 2011. The Billerica, Mass.-based company said it expects the sale to close sometime in the 1st quarter, and said it expects the sale to improve the company’s gross margins annually by low-to-mid single digits. When Insulet picked up Neighborhood Diabetes for $63 million in June 2011, the purchase tripled Insulet’s customer base, according to the company. Insulet CFO Brian Roberts told MassD...
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diabetes Mergers & Acquisitions Insulet Corp. Source Type: news

MassDevice.com +3 | The top 3 medtech stories for January 12, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.   3. Insulet inks deal for Lilly’s Humalog concentrated insulin Insulet said yesterday that it inked a deal with Eli Lilly to develop a version of its flagship OmniPod device that uses a concentrated insulin made by the pharma giant. Lilly’s Humalog U200, which delivers 200 units of ins...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Insulet inks deal for Lilly’s Humalog concentrated insulin
Insulet (NSDQ:PODD) said yesterday that it inked a deal with Eli Lilly (NYSE:LLY) to develop a version of its flagship OmniPod device that uses a concentrated insulin made by the pharma giant. Lilly’s Humalog U200, which delivers 200 units of insulin per milliliter, is for patients who need higher doses of insuling to control their diabetes, Billerica, Mass.-based Insulet said. The deal calls for the companies to evaluate the use of Humalog U200 in the OmniPod insulin delivery system. “We are thrilled to partner with Lilly to develop the first insulin pump specifically designed for Humalog U200 i...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Diabetes Pharmaceuticals Eli Lilly & Co. Insulet Corp. Source Type: news

Adocia and Lilly begin Phase Ib trial of BioChaperone Lispro to treat type 2 diabetes
Adocia and Eli Lilly have started a Phase Ib clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly for the treatment of patients with type 2 diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - September 30, 2015 Category: Pharmaceuticals Source Type: news

Bigfoot acquires Asante assets, inks deal with Dexcom
Bigfoot Biomedical is making strides towards its goal of a bionic pancreas after inking a deal with Dexcom Inc. (NSDQ:DXCM), maker of continuous glucose monitors, and acquiring the assets of shuttered insulin pump maker Asante. Bigfoot also said it will be relocating to Milpitas, Calif., where Asante was headquartered. The deal signed with Dexcom is slated to allow Bigfoot to integrate data from Dexcom’s continuous glucose monitoring systems into its insulin delivery system, it said last week. The deal makes sense, as the “homebrew artificial pancreas” system created by Bigfoot co-founder B...
Source: Mass Device - June 9, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diabetes Mergers & Acquisitions mHealth (Mobile Health) Asante Solutions Bigfoot Biomedical DexCom Inc. newtag Source Type: news

Biodel Reports Positive Top-Line Results From Clinical Study Of Ultra-Rapid-Acting Insulin Analog Candidates
Biodel Inc. (Nasdaq:BIOD) today announced positive top-line results from a Phase 1 clinical trial of two ultra-rapid-acting insulin analog-based formulations, BIOD-238 and BIOD-250, conducted to evaluate the pharmacokinetic and injection site toleration profiles relative to Humalog®, a rapid-acting insulin analog. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - January 25, 2013 Category: Pharmaceuticals Source Type: news