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New Real-World Analysis Shows INVOKANA ® (canagliflozin) and Other SGLT2 Inhibitors Reduced the Risk of Death and Cardiovascular Events Compared to Other Diabetes Medicines
(Source: Johnson and Johnson)
Source: Johnson and Johnson - November 17, 2017 Category: Pharmaceuticals Source Type: news

INVOKANA ® (canagliflozin) Demonstrates Cardiovascular (CV) Risk Reductions in Type 2 Diabetes Patients With and Without a History of Prior CV Events
(Source: Johnson and Johnson)
Source: Johnson and Johnson - November 14, 2017 Category: Pharmaceuticals Source Type: news

INVOKANA ® (canagliflozin) Significantly Improved Renal Outcomes and Demonstrated Potential Renal Protective Effects in Patients with Type 2 Diabetes Who Have or Are at Risk for Cardiovascular Disease
Late-breaking renal data from the integrated CANVAS Program presented at the American Society of Nephrology Kidney Week 2017 Annual Meeting (Source: Johnson and Johnson)
Source: Johnson and Johnson - November 3, 2017 Category: Pharmaceuticals Source Type: news

CANVAS: Straight Talk Needed on Amputation Risk CANVAS: Straight Talk Needed on Amputation Risk
Can a meta-analysis of two different studies or data from observational studies overcome the clinical concern about the clear-cut amputation risk with canagliflozin seen in the CANVAS trial?Medscape Diabetes & Endocrinology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 16, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology Expert Column Source Type: news

Janssen submits sNDA to FDA for Invokana to reduce risk of MACE
Janssen Research and Development has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular events (MACE). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 4, 2017 Category: Pharmaceuticals Source Type: news

Janssen Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for INVOKANA ® (canagliflozin) to Reduce the Risk of Major Adverse Cardiovascular Events (MACE) Based on Landmark CANVAS Program
Filing includes data on the combined risk reduction of cardiovascular death, myocardial infarction and stroke in patients with type 2 diabetes (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 2, 2017 Category: Pharmaceuticals Source Type: news

Deals this week: Mundipharma Medical Company, Cooper Pharmal Sarl, Merck
Mundipharma Medical Company will exclusively distribute INVOKANA (canagliflozin) and VOKANAMET (canagliflozin and metformin) in the European Economic Area (EEA) and Switzerland, under an agreement signed with drug developer and manufacturer Janssen P … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 7, 2017 Category: Pharmaceuticals Source Type: news

Janssen and Mundipharma sign distribution deal for type 2 diabetes treatments
Janssen Pharmaceutica has entered an exclusive distribution agreement with Mundipharma Medical Company for Invokana (canagliflozin) and Vokanamet (a fixed-dose combination therapy of canagliflozin and metformin) to treat patients with type 2 diabetes … (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - September 4, 2017 Category: Pharmaceuticals Source Type: news

Some Physicians Switch Patients Off Invokana after FDA Warning
(MedPage Today) -- Doubled risk of amputations appears to be affecting usage (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 2, 2017 Category: Cardiology Source Type: news

Positive Cardiac Biomarker Changes Seen With Canagliflozin in T2D Positive Cardiac Biomarker Changes Seen With Canagliflozin in T2D
Canagliflozin suppressed the increase in NT-proBNP and high-sensitivity troponin in older patients with type 2 diabetes, which may help shed some light on the beneficial CV effect of SGLT2 inhibitors.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 8, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

FDA Reports Further Support for Canagliflozin-Amputation Link FDA Reports Further Support for Canagliflozin-Amputation Link
The data are still insufficient to change prescribing recommendations, but they do suggest caution in prescribing canagliflozin for people at increased amputation risk.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 4, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

CANVAS Proves CV Safety, Metabolic Value of Canagliflozin CANVAS Proves CV Safety, Metabolic Value of Canagliflozin
British diabetes expert Clifford Bailey offers his take on the CANVAS dataMedscape Diabetes & Endocrinology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 30, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology Commentary Source Type: news

CANVAS: Experts Spar on Canagliflozin Risk/Benefit in Diabetes CANVAS: Experts Spar on Canagliflozin Risk/Benefit in Diabetes
Some see the newly revealed cardiovascular benefits as rendering canagliflozin essentially"interchangeable" with empagliflozin, while others view the amputation signal as a deal breaker.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 16, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Janssen reports positive results from CANVAS programme of canagliflozin
Janssen-Cilag International has reported positive results from the CANVAS programme of INVOKANA (canagliflozin) in combination with standard-of-care to address a combined risk of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non … (Source: Drug Development Technology)
Source: Drug Development Technology - June 13, 2017 Category: Pharmaceuticals Source Type: news

ADA: Canagliflozin Cuts Heart Risk in T2D (CME/CE)
(MedPage Today) -- But CANVAS program reveals risk of amputation, fracture (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - June 13, 2017 Category: Consumer Health News Source Type: news

New diabetes pill costs just £1.30 a day
Canagliflozin, a pill taken once a day before breakfast, is designed to lower blood sugar levels and keep weight down. Experts last night said the study heralds a 'new era' in treatment. (Source: the Mail online | Health)
Source: the Mail online | Health - June 13, 2017 Category: Consumer Health News Source Type: news

INVOKANA ® (canagliflozin) Significantly Reduces the Combined Risk of Cardiovascular Death, Myocardial Infarction and Stroke in the CANVAS Program
Study results published in the New England Journal of Medicine and featured in a special symposium at the American Diabetes Association 77th Scientific Sessions (Source: Johnson and Johnson)
Source: Johnson and Johnson - June 13, 2017 Category: Pharmaceuticals Source Type: news

CANVAS: Canagliflozin Reduces CV Events, but at Cost of Amputations CANVAS: Canagliflozin Reduces CV Events, but at Cost of Amputations
Pooled data from two CANVAS trials suggest that cardioprotection is likely a class effect with SGLT2 inhibitors, but it comes at the price of toe amputations.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 12, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

J & J diabetes drug shows heart benefit in large safety study
(Reuters) - Johnson& Johnson's type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting on Monday. (Source: Reuters: Health)
Source: Reuters: Health - June 12, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

J & J Drug Prevents Heart Attacks At Cost Of Amputated Toes
In a blow to J&J, for every three heart attacks, strokes, or cardiovascular deaths prevented by Invokana, there were two amputations, 71% of them of toes or the lower foot, according to the results of the 10,142-patient study. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - June 12, 2017 Category: Pharmaceuticals Authors: Matthew Herper, Forbes Staff Tags: NYSE:JNJ NYSE:MRK NYSE:LLY Source Type: news

7 medtech stories we missed this week: May 26, 2017
[Image from unsplash.com]From Merck’s new licensing agreement to surgical study data being touted, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Merck inks exclusive licensing agreement for Alzheimer’s antibody Merck announced in a May 25 press release that it has entered an exclusive worldwide license agreement with Teijin Pharma. The licensing agreement is going to help with the development, manufacture and commercialization of an investigation preclinical antibody candidate that targets the protein tau. Merck will have exclusive worldwide rights to develop, manufa...
Source: Mass Device - May 26, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Patient Monitoring Pharma Pharmaceuticals Research & Development Surgical EarlySense Janssen Pharmaceuticals Life Spine Inc. Masimo MedTech Merck Midmark Procept BioRobotics Shenzhen Lachesis Mhealth Teijin Pharma Thermi Source Type: news

FDA Warns of Amputation Risk Linked to Newer Diabetes Drug
The FDA has called for a new boxed warning to be added to canagliflozin product labels based on a heightened risk for leg and foot amputations associated with use of the drug. (Source: AAFP News)
Source: AAFP News - May 22, 2017 Category: Primary Care Source Type: news

FDA Warning: Diabetes Drug Has Amputation Risk
Canagliflozin tied to a doubling of amputations of legs, feet, agency says (Source: WebMD Health)
Source: WebMD Health - May 17, 2017 Category: Consumer Health News Source Type: news

Diabetes Drug Gets FDA Warning Due to Amputation Risk
Canagliflozin tied to a doubling of amputations of legs, feet, agency says (Source: WebMD Health)
Source: WebMD Health - May 17, 2017 Category: Consumer Health News Source Type: news

Diabetes Drug Gets FDA Warning Due to Amputation Risk
Canagliflozin tied to a doubling of amputations of legs, feet, agency says Source: HealthDay Related MedlinePlus Pages: Diabetes Medicines, Diabetes Type 2, Limb Loss (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 17, 2017 Category: Consumer Health News Source Type: news

Diabetes Drug Gets FDA Warning Due to Amputation Risk
WEDNESDAY, May 17, 2017 -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration now says. The FDA is... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - May 17, 2017 Category: General Medicine Source Type: news

FDA Adds Boxed Warning to Canagliflozin for Increased Amputation Risk (FREE)
By Kristin J. Kelley Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM The FDA is adding new warnings — including a boxed warning — to labels for … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - May 17, 2017 Category: Primary Care Source Type: news

FDA warns of foot, leg amputations with J & J diabetes drug
(Reuters) - Johnson& Johnson is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - May 16, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA: Boxed Warning for Canagliflozin on Amputation Risk
(MedPage Today) -- Post-marketing trial data show doubled rates compared to placebo (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 16, 2017 Category: Endocrinology Source Type: news

FDA Adding Boxed Warning to Canagliflozin for Amputation Risk FDA Adding Boxed Warning to Canagliflozin for Amputation Risk
On the basis of new information from two cardiovascular outcomes trials suggesting a doubled amputation risk, the FDA will now require a boxed warning on canagliflozin's label.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 16, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA Adds Boxed Warning to Canagliflozin for Amputation Risk FDA Adds Boxed Warning to Canagliflozin for Amputation Risk
On the basis of new information from two cardiovascular outcomes trials suggesting a doubled amputation risk, the FDA will now require a boxed warning on canagliflozin's label.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 16, 2017 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
Based on new data from two large clinical trials, FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your healthcare professional if you have questions or concerns. Do not stop taking your diabete...
Source: FDA Center for Drug Evaluation and Research - What's New - May 16, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
[5-XX-2016] The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 9, 2017 Category: Drugs & Pharmacology Source Type: news

Real-World Evidence Shows Oral INVOKANA ® 300 mg Demonstrates Comparable A1C Reduction and Control to Injectable GLP-1 Receptor Agonists
Patients Taking INVOKANA ® 300 mg Were Significantly Less Likely to Discontinue the Medication or Be Prescribed a New Antihyperglycemic Agent (Source: Johnson and Johnson)
Source: Johnson and Johnson - May 6, 2017 Category: Pharmaceuticals Source Type: news

Invokamet (Canagliflozin and Metformin Hydrochloride Tablets) - 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

Invokamet XR (canagliflozin and metformin hydrochloride) - 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

Invokana (Canagliflozin Tablets) - 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

EMA: Amputation Warning With SGLT2 Inhibitors Must Be on Label EMA: Amputation Warning With SGLT2 Inhibitors Must Be on Label
Lower-limb (mostly toe) amputation risk seen in canagliflozin clinical trials, but EMA panel says all SGLT2 inhibitors should carry the label warning.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - February 10, 2017 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Randomized trial will reveal diabetes drug's effects on kidney health
(Wiley) Type 2 diabetes often causes damaging effects to the kidneys, sometimes resulting in the need for dialysis or kidney transplantation. The ongoing CANVAS-R trial is testing whether canagliflozin -- a member of a new class of diabetes treatments known as sodium glucose co-transporter 2 (SGLT2) inhibitors -- can slow kidney function decline and provide other benefits to diabetic patients. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - January 25, 2017 Category: Global & Universal Source Type: news

The Year In Review: Merck Can Look Back And Smile
Merck has had a reasonably good year. The company saw a turn-around in its business on the back of its relatively new cancer drug, Keytruda. The anti-infectives division sustained itself, with key metabolism drugs Januvia and Janumet gradually inching up. In fact, the competitive pressure from J&J ’s Invokana, which threatened [...] (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - December 13, 2016 Category: Pharmaceuticals Authors: Trefis Team, Contributor Tags: NYSE:MRK Source Type: news

Money in Medicine: The top 30 drugs associated with pharma industry payments to Oregon doctors
The top 30 drugs associated with pharmaceutical industry payments to doctors are, for the most part, not household names. The top three — Bydureon, Invokana and Toujeo — are prescribed for diabetes, testament to the prevalence of the disease. Three others on the list are prescribed for multiple sclerosis. Hysingla, a an abuse-deterrent hydrocodone pill, is also high on the list. The makers of these drugs pay doc tors in Oregon and across the nation billions of dollars for consulting fees, talks… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - November 21, 2016 Category: Pharmaceuticals Authors: Elizabeth Hayes Source Type: news

Money in Medicine: The top 30 drugs associated with pharma industry payments to Oregon doctors
The top 30 drugs associated with pharmaceutical industry payments to doctors are, for the most part, not household names. The top three — Bydureon, Invokana and Toujeo — are prescribed for diabetes, testament to the prevalence of the disease. Three others on the list are prescribed for multiple sclerosis. Hysingla, a an abuse-deterrent hydrocodone pill, is also high on the list. The makers of these drugs pay doc tors in Oregon and across the nation billions of dollars for consulting fees, talks… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - November 21, 2016 Category: Biotechnology Authors: Elizabeth Hayes Source Type: news

Invokamet XR for the Treatment of Type 2 Diabetes in Adults
Developed by Janssen Pharmaceuticals, Invokamet XR (Canagliflozin / Metformin Hydrochloride Extended Release) is indicated for the treatment of Type 2 diabetes in adults. (Source: Drug Development Technology)
Source: Drug Development Technology - November 17, 2016 Category: Pharmaceuticals Source Type: news

Invokamet XR (canagliflozin and metformin hydrochloride) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 30, 2016 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves INVOKAMET(R) XR (Canagliflozin / Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
RARITAN, N.J., Sept. 21, 2016 -- (Healthcare Sales & Marketing Network) -- Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR—a once-daily, fixed-dose combination therapy of c... Biopharmaceuticals, Endocrinology, FDA Janssen, INVOKAMET, Canagliflozin, Metformin, diabetes (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 21, 2016 Category: Pharmaceuticals Source Type: news

FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
RARITAN, N.J., September 21, 2016 – Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved Invokamet XR - a once-daily, fixed-dose combination therapy of canagliflozin and metformin... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 21, 2016 Category: Drugs & Pharmacology Source Type: news

3 Simple Ways to Manage Diabetes
Image Source With as much as three million Americans living with type 1 diabetes (T1B), and an alarming 371 million of the world's population living with the disease, finding an effective and yet simple way to manage it is a step anyone with diabetes should look to. With no current cure, diabetes easily falls among one of the world's scariest diseases. Experts have recommended maintaining a healthy living and eating habit as a way to manage the disease and/or prevent it for those who are yet to be diagnosed with it. For people who have been diagnosed with diabetes, worrying and allowing the ailment to get the better part...
Source: Healthy Living - The Huffington Post - September 2, 2016 Category: Consumer Health News Source Type: news

New oral diabetes drugs may also protect patients' kidney health
In a clinical trial of patients with type 2 diabetes, canagliflozin (a sodium-glucose cotransporter 2 inhibitor) slowed kidney function decline to a greater extent than glimepiride (a sulfonylurea), while having similar blood sugar –lowering effects, report investigators. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 19, 2016 Category: Science Source Type: news

Canagliflozin benefits cohort of type 1 diabetes patients
NEW ORLEANS – Compared with placebo, canagliflozin improved glycemic control and reduced glycemic variability over 18 weeks in adults with type 1 diabetes that had been inadequately controlled with... (Source: Clinical Endocrinology News)
Source: Clinical Endocrinology News - July 11, 2016 Category: Endocrinology Source Type: news

EMA Extends Amputation Investigation to All SGLT2 InhibitorsEMA Extends Amputation Investigation to All SGLT2 Inhibitors
In a revision of its April 2016 notice regarding canagliflozin and amputations, the EMA's Pharmacovigilance Risk Assessment Committee is now investigating all drugs in the class. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - July 8, 2016 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news