FDA accepts Intarcia ’ s NDA for diabetes drug-device combo
Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure.
The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments and other small molecules at or above human body temperatures for up to 3 years. Once the mini-pump is placed under the skin, water from extracellular fluid enters the device at 1 end, diffusing through a s...
Source: Mass Device - February 6, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Wall Street Beat Intarcia Therapeutics Source Type: news
Byetta (Exenatide Injection) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 31, 2017 Category: Drugs & Pharmacology Source Type: news
Exenatide-Pioglitazone Combo Tops Insulin in Type 2 Diabetes Exenatide-Pioglitazone Combo Tops Insulin in Type 2 Diabetes
The combination lowers HbA1c more effectively with less weight gain and hypoglycemia in type 2 diabetes patients poorly controlled on metformin plus a sulfonylurea in the Qatar study.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - January 17, 2017 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news
Oramed touts phase Ib data for type 2 diabetes capsule
Oramed Pharmaceuticals (NSDQ:ORMP) said today that it finished a phase Ib study of its oral GLP-1 analog capsule for type 2 diabetes.
Glucagon-like peptide-1 (GLP-1) is a hormone that stimulates the pancreas to secrete insulin. Exenatide, a GLP-1 analog, is available on the market as an injection for patients with type 2 diabetes. The analog stimulates insulin release at increased glucose levels and can result in reduced food intake, along with weight loss.
Get the full story at our sister site, Drug Delivery Business News.
The post Oramed touts phase Ib data for type 2 diabetes capsule appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Oramed Therapeutics Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 21, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. Zimmer Biomet readies $1B tenders for senior debt
Zimmer Biomet said today that it plans to float tender offers for some $1.1 billion worth of senior notes. The tenders are aimed at lowering the debt load it took on when Zimmer...
Source: Mass Device - November 21, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Intarcia seeks FDA nod for Medici drug delivery system
Intarcia Therapeutics said today that it submitted a New Drug Application to the FDA for its injection-free ITCA 650 candidate, the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The ITCA 650 enables subcutaneous delivery of exenatide using a match-sized osmotic pump placed under the skin in an in-office procedure.
With the NDA submission, the Boston-based company triggered a 3rd, $100 million milestone payment from the $300 million royalty financing put in place in the 2nd quarter of 2015. The milestone payment adds to the $215 million Intarcia raised in September.
Get the ful...
Source: Mass Device - November 21, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Diabetes Drug-Device Combinations Food & Drug Administration (FDA) Implants Pharmaceuticals Regulatory/Clearance Intarcia Therapeutics Source Type: news
Expensive New Diabetes Drugs Add Nothing But Cost And Complications
This is the fourth in an ongoing series of blogs exposing the rampant misuse of the medications so aggressively promoted by greedy drug companies.
I am very lucky in having the perfect partner in this truth-vs-power effort to contradict Pharma propaganda with evidence based fact.
Dick Bijl is President of the International Society of Drug Bulletins (ISDB), an impressive association of 53 national drug bulletins from all around the world, each of which publishes the best available data on the pluses and minuses of different medications.
Drug bulletins help patients and doctors see through the misleading misinformation ge...
Source: Science - The Huffington Post - November 17, 2016 Category: Science Source Type: news
Exenatide Disappoints in Cardiac Arrest Exenatide Disappoints in Cardiac Arrest
The GLP-1 analog had no effect on a marker of neurological injury, but there was a hint of a possible reduction in mortality, in a new study.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 12, 2016 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
First Data on GLP-1 Agonist/SGLT2 Inhibitor Combo in Diabetes First Data on GLP-1 Agonist/SGLT2 Inhibitor Combo in Diabetes
Exenatide once weekly combined with daily dapagliflozin improved glycemic outcomes, BP, and weight loss more than each drug alone in DURATION-8, the first trial to examine a combination of these 2 agents.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - September 20, 2016 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news
Intarcia raises another $215m to support its ITCA 650 drug pump
Intarcia Therapeutics said today it raised $215 million in a new round of financing to support the approval and launch of its ITCA 650 implantable drug pump, designed for treating type 2 diabetes, which the company has slated to launch in late 2017.
The Cambridge, Mass.-company said it expects a “larger second close with additional top-tier investors” in the 4th quarter. Intarcia is looking to raise up to $600 million by the end of the year to support the approval and launch of the device, according to a report from the Boston Business Journal.
The ITCA 650 implantable drug pump is a matchstick-sized, minia...
Source: Mass Device - September 15, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diabetes Drug Pumps Intarcia Therapeutics Source Type: news
Teva, AstraZeneca settle patent dispute over multimillion-dollar drug
Teva Pharmaceuticals USA Inc. said Thursday it has settled patent litigation with AstraZeneca Pharmaceuticals and Amylin Pharmaceuticals that involved the prescription medicine Byetta.
Byetta is an injectable drug used to improve blood sugar control in adults with type 2 diabetes. The drug generated revenues of $316 million for AstraZeneca in 2015.
Under the terms of the settlement, AstraZeneca (NYSE: AZN) granted a license to Teva (NYSE: TEVA) to manufacture and commercialize the generic version… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 23, 2016 Category: Pharmaceuticals Authors: John George Source Type: news
Subdermal mini-pump with exenatide superior to sitagliptin in reducing HbA1c
NEW ORLEANS – The second trial involving a sub-dermal matchstick-size osmotic mini-pump that releases exenatide over 6 months in people who have poorly controlled type 2 diabetes achieved superior... (Source: Clinical Endocrinology News)
Source: Clinical Endocrinology News - June 12, 2016 Category: Endocrinology Source Type: news
Intarcia raises another $75m, touts top-line safety data in pivotal trial
Intarcia Therapeutics said today that it raised another $75 million in a debt financing round and touted the top-line cardiovascular safety data from the final phase in its clinical program for its ITCA 650 implantable drug pump for Type II diabetics.
Boston-based Intarcia said it plans to begin filing for U.S. approval from the FDA during the 3rd quarter, now that the safety data is in from its 4,000-patient Freedom-CVO trial. The debt financing, a new credit facility with MidCap Financial and Silicon Valley Bank, is slated for scaling up its manufacturing for the ITCA 650, the company said.
The device is a matchstic...
Source: Mass Device - May 6, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Diabetes Food & Drug Administration (FDA) Funding Roundup Regulatory/Compliance Intarcia Therapeutics Source Type: news
Additional benefits of type 2 diabetes treatment found for non-alcoholic fatty liver disease patients
A type 2 diabetes treatment has been found to also have 'off-label' benefits for glucose control in the liver and in fatty cells known as adipose. The study shows that exenatide, a treatment that targets the pancreas to improve glucose absorption, enhances glucose uptake and reduces insulin resistance in the liver and in adipose tissue. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - April 15, 2016 Category: Science Source Type: news
Additional benefits of type 2 diabetes treatment found for non-alcoholic fatty liver disease patients
(European Association for the Study of the Liver) A type 2 diabetes treatment has been found to also have 'off-label' benefits for glucose control in the liver and in fatty cells known as adipose. Presented at The International Liver CongressTM 2016 in Barcelona, Spain, today, the study shows that exenatide, a treatment that targets the pancreas to improve glucose absorption, enhances glucose uptake and reduces insulin resistance in the liver and in adipose tissue. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - April 15, 2016 Category: Infectious Diseases Source Type: news
