Timely Access: The Waiting Game
Innovation in pharma is in itself a complex and drawn-out process – where inspiration and perspiration merge over years to produce a novel compound or molecule that will benefit human health. Yet while this process has been increasingly streamlined as science and technology progresses, drug approval processes remain a painstaking process that can significantly delay access to groundbreaking and effective therapies. Despite the central role of industry in healthcare delivery, outcomes and development, innovation in the form of lifesaving or life-prolonging medicines is now being scuppered by lengthy gaps between marke...
Source: EyeForPharma - February 25, 2016 Category: Pharmaceuticals Authors: Danielle Barron Source Type: news

SGLT2 inhibitors and diabetic ketoacidosis
The European Medicines Agency (EMA) urges healthcare professionals to be aware of signs of diabetic ketoacidosis (DKA) in people with type 2 diabetes who are taking SGLT2 inhibitors. Diabetes.co.uk (Source: Society for Endocrinology)
Source: Society for Endocrinology - February 23, 2016 Category: Endocrinology Source Type: news

EMA on Lowering Risk of Diabetic Ketoacidosis With SGLT2 InhibitorsEMA on Lowering Risk of Diabetic Ketoacidosis With SGLT2 Inhibitors
The EMA completes review of risk of diabetic ketoacidosis with the use of SGLT2 inhibitors in type 2 diabetes and urges medics to look out for atypical presentation with only mildly elevated glucose levels. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - February 12, 2016 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Safety of Empagliflozin in Drug Naive T2D PatientsSafety of Empagliflozin in Drug Naive T2D Patients
Could this SGLT2 inhibitor help to successfully manage type 2 diabetes in previously untreated patients -- without increasing cardiometabolic risk? Cardiovascular Diabetology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 10, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

CV Risk Reduction Claim for Empagliflozin Filed With US FDACV Risk Reduction Claim for Empagliflozin Filed With US FDA
The companies marketing the SGLT2 inhibitor empagliflozin for type 2 diabetes have filed an sNDA for a cardiovascular risk reduction claim with the US FDA, based on the data from the EMPA-REG trial. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 25, 2016 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

FDA Warns of Ketoacidosis, UTIs With SGLT2 Inhibitors
Manufacturers of sodium-glucose cotransporter-2 inhibitors are being required to add label warnings about the risks of ketoacidosis and urinary tract infections associated with their use. (Source: AAFP News)
Source: AAFP News - December 8, 2015 Category: Primary Care Source Type: news

Safety Warnings Added to Newer Diabetes Drugs (FREE)
By Kristin J. Kelley Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH The labels of sodium-glucose co-transporter 2 (SGLT2) inhibitors — drugs used to treat type 2 diabetes — will be updated to warn of the risks for ketoacidosis … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - December 7, 2015 Category: Primary Care Source Type: news

FDA Adds Warnings to SGLT2 InhibitorsFDA Adds Warnings to SGLT2 Inhibitors
The FDA has updated warnings in the labels for SGLT2 inhibitors to include the risks for ketoacidosis and severe urinary tract infections. News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 4, 2015 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections
Labeling changes describe risks of ketoacidosis, urosepsis and pyelonephritis. (Source: FDA MedWatch)
Source: FDA MedWatch - December 4, 2015 Category: American Health Source Type: news

FDA Adds New Warnings on SGLT2 Inhibitors
(MedPage Today) -- Calls attention to ketoacidosis, UTI risks (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 4, 2015 Category: Cardiology Source Type: news

Empagliflozin's CV Gains Explored in Diabetics With, Without HFEmpagliflozin's CV Gains Explored in Diabetics With, Without HF
Given the specter of associated heart failure with some antidiabetic medications, deeper analysis of the recently reported EMPA-REG OUTCOME trial of the SGLT2 inhibitor may reassure. Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 17, 2015 Category: Cardiology Tags: Cardiology News Source Type: news

Empagliflozin's CV Gains Seen in Diabetics With, Without HFEmpagliflozin's CV Gains Seen in Diabetics With, Without HF
Given the specter of associated heart failure with some antidiabetic medications, deeper analysis of the recently reported EMPA-REG OUTCOME trial of the SGLT2 inhibitor may reassure. Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - November 16, 2015 Category: Cardiology Tags: Cardiology News Source Type: news

Minimizing DKA Risk With SGLT2 Inhibitors in Type 1 DiabetesMinimizing DKA Risk With SGLT2 Inhibitors in Type 1 Diabetes
Could dose titration and ketone monitoring make drugs designed for type 2 diabetes safe in type 1 diabetes? Medscape Diabetes & Endocrinology (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - October 28, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology Commentary Source Type: news

SGLT2-Inhibitor Benefit Outweighs Ketoacidosis Risk, Says AACESGLT2-Inhibitor Benefit Outweighs Ketoacidosis Risk, Says AACE
Regulators in the US and Europe issued warnings earlier this year that the drugs may cause diabetic ketoacidosis, but in a 2-day conference, medical societies chose not to change their guidelines. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - October 28, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

SGLT2 Inhibitors in the Early Treatment of Type 2 DiabetesSGLT2 Inhibitors in the Early Treatment of Type 2 Diabetes
While SGLT2 inhibitors have been targeted at patients with long-standing type 2 diabetes, could they also offer significant benefit in early management? International Journal of Clinical Practice (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 15, 2015 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

First Data on SGLT2 Inhibitor Canagliflozin in Type 1 DiabetesFirst Data on SGLT2 Inhibitor Canagliflozin in Type 1 Diabetes
In a phase 2 study in type 1 diabetes, canagliflozin improved glycemic control without causing weight gain, but the risk for diabetic ketoacidosis was slightly elevated. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - September 22, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Invokana May Increase Bone Fracture Risk: FDA
(MedPage Today) -- Follows evidence linking the SGLT2 inhibitor to fractures (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - September 10, 2015 Category: Cardiology Source Type: news

Diabetic Ketoacidosis With SGLT2 Inhibitors Is ManageableDiabetic Ketoacidosis With SGLT2 Inhibitors Is Manageable
Two diabetes clinical trialists argue that SGLT2 inhibitors are still safe and effective despite the diabetic ketoacidosis risk, including in patients with type 1 diabetes. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - September 7, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

CardioBrief: At Last, a Positive Diabetes Drug Outcomes Trial?
(MedPage Today) -- Study of SGLT2 inhibitor empagliflozin may be the first to show cardiovascular benefit (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - August 21, 2015 Category: Neurology Source Type: news

The 2013 Merck-Pfizer Diabetes Deal Now Looks Very Savvy
The Jardiance results will certainly cause physicians to consider prescribing SGLT2 inhibitors over other classes of drugs. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - August 20, 2015 Category: Pharmaceuticals Authors: John LaMattina Source Type: news

Beware of skin complications of newer antidiabetic agents
VANCOUVER, B.C. – Each of the newer classes of antidiabetic medications – the DPP-IV inhibitors, GLP-1 agonists, and SGLT2 inhibitors – has its own characteristic cutaneous side effects, Dr. Justin Endo said at the World Congress of Dermatology. These drugs aren’t first-line agents for patients... (Source: Skin and Allergy News)
Source: Skin and Allergy News - August 11, 2015 Category: Dermatology Source Type: news

Safety review launched into diabetic drugs
GPs warned to monitor patients taking SGLT2 inhibitors Related items from OnMedicaDiabetes drugs not linked to bladder cancerLong-acting GLP-1 agonists for type 2 diabetesDiabetes drug could protect against Parkinson’s diseaseYellow Card scheme goes mobile with first app (Source: OnMedica Latest News)
Source: OnMedica Latest News - July 24, 2015 Category: UK Health Source Type: news

UCLA researchers identify new mechanism that delivers glucose to cancer cells
UCLA scientists have identified a new mechanism that delivers a key substance that fuels the growth of pancreatic and prostate cancer cells, a finding that offers new hope in the fight against two of the deadliest forms of the disease. Cancer cells require high amounts of the sugar glucose to survive and grow, and long-standing research has established passive glucose transporters, known as GLUTS, as the primary method the body uses to deliver glucose to tumors. UCLA Ernest Wright But the results of a three-year study by UCLA researchers, demonstrated that pancreatic and prostate cancer cells also utilize glucose from so...
Source: UCLA Newsroom: Health Sciences - July 14, 2015 Category: Universities & Medical Training Source Type: news

Canada Reviews Diabetic Ketoacidosis Risk With SGLT2 InhibitorsCanada Reviews Diabetic Ketoacidosis Risk With SGLT2 Inhibitors
Canada has become the latest country to investigate the association between SGLT2-inhibitor use in diabetes patients and the risk of euglycemic ketoacidosis. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - June 30, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

'Understand This Warning': SGLT2s and Ketoacidosis'Understand This Warning': SGLT2s and Ketoacidosis
Dr Anne Peters describes case examples of euglycemic ketoacidosis linked to SGLT2 inhibitors used to treat type 2 diabetes. Medscape Diabetes & Endocrinology (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - June 22, 2015 Category: Drugs & Pharmacology Tags: Diabetes & Endocrinology Commentary Source Type: news

After DKA Warning, Avoid SGLT2-Inhibitor Use in Type 1 DiabetesAfter DKA Warning, Avoid SGLT2-Inhibitor Use in Type 1 Diabetes
A case series finds 13 episodes of euglycemic diabetic ketoacidosis associated with SGLT2-inhibitor use in both types of diabetes; the authors advise avoiding these agents in those with type 1 diabetes. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - June 20, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

EMA to Review Diabetic Ketoacidosis Risk With SGLT2 InhibitorsEMA to Review Diabetic Ketoacidosis Risk With SGLT2 Inhibitors
The European Medicines Agency reports 101 cases of diabetic ketoacidosis associated with use of SGLT2 inhibitors for treatment of type 2 diabetes, begins review to see if any change to use required. News Alerts (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - June 12, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

FDA Safety Warning For Invokana, Other SGLT2 Inhibitor Type 2 Diabetes...
The new Invokana website was launched to provide the public with updated information on the potential association between the use of SGLT2 inhibitors like Invokana and diabetic ketoacidosis.(PRWeb June 11, 2015)Read the full story at http://www.prweb.com/releases/invokana-ketoacidosis/invokana-lawsuit/prweb12783059.htm (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - June 12, 2015 Category: Pharmaceuticals Source Type: news

Type II diabetes: Synjardy® approved in the EU
Synjardy® has been granted marketing authorisation by the European Commission for the treatment of adults with type II diabetes (T2D) in the European Union (EU). Synjardy® is a new single-pill combination therapy from the Boehringer Ingelheim and Eli Lilly and Company diabetes alliance. (Source: Pharmacy Europe)
Source: Pharmacy Europe - May 29, 2015 Category: Drugs & Pharmacology Authors: Annabel De Coster Tags: *** Editor's Pick Clinical trials Practical therapeutics Diabetes blood glucose-lowering drugs empagliflozin glycaemic control Jardiance Latest News metformin odium glucose cotransporter 2 SGLT2 synjardy T2D Source Type: news

FDA's New Diabetes Drug Warning Includes Meds from J&J, AstraZeneca, Lilly
The U.S. FDA has warned that sodium-glucose cotransporter-2 (SGLT2) inhibitors -- a class of type 2 diabetes drugs -- can lead to ketoacidosis. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - May 19, 2015 Category: Pharmaceuticals Source Type: news

FDA Issues Warning for Type 2 Diabetes Drugs
SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis (Source: WebMD Health)
Source: WebMD Health - May 18, 2015 Category: Consumer Health News Source Type: news

FDA Issues Warning for Type 2 Diabetes Drugs
SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis Source: HealthDay Related MedlinePlus Pages: Diabetes Complications, Diabetes Medicines, Diabetes Type 2 (Source: MedlinePlus Health News)
Source: MedlinePlus Health News - May 18, 2015 Category: Consumer Health News Source Type: news

SGLT2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: FDASGLT2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: FDA
Reports of ketoacidosis requiring hospitalization in patients with type 2 diabetes taking sodium-glucose cotransporter-2 inhibitors prompts FDA drug safety communication. News Alerts (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - May 16, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns
(MedPage Today) -- FDA targets SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - May 16, 2015 Category: Cardiology Source Type: news

SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 (Source: FDA MedWatch)
Source: FDA MedWatch - May 15, 2015 Category: American Health Source Type: news

Dapagliflozin in Patients With Type 2 Diabetes MellitusDapagliflozin in Patients With Type 2 Diabetes Mellitus
Where does this SGLT2 inhibitor fit in type 2 diabetes therapy? Therapeutic Advances in Endocrinology and Metabolism (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 10, 2015 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

First Pill Combining New Diabetes Drugs OK'd
(MedPage Today) -- The FDA has approved a single pill containing SGLT2 and DPP-4 inhibitors. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 3, 2015 Category: Cardiology Source Type: news

FDA Approves Novel Combination Pill for Type 2 DiabetesFDA Approves Novel Combination Pill for Type 2 Diabetes
The FDA has approved the first oral glucose-lowering drug that combines an SGLT2 inhibitor with a DPP-4 inhibitor. FDA Approvals (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - February 3, 2015 Category: Endocrinology Tags: Diabetes & Endocrinology News Alert Source Type: news

Look into SGLT2 Fracture Risk, Researchers Urge
(MedPage Today) -- Post menopausal women may need close follow. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 18, 2014 Category: Cardiology Source Type: news

New Diabetes Meds: The Year in Review (CME/CE)
(MedPage Today) -- 2014 was the year of the SGLT2 inhibitors in diabetes management. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 11, 2014 Category: Cardiology Source Type: news

Top medicine articles for November 2014
A collection of some interesting medical articles published recently:'To Burn Off Calories in This Soda, Walk 5 Miles' - new label http://buff.ly/1vzbCKHTwo new medications for IPF: Pirfenidone (Esbriet) affects scarring, Nintedanib (Ofev) is a kinase inhibitor http://buff.ly/1psam6m80% of people have at least 1 distressing symptom in a given month, yet fewer than 1 in 4 persons sees a doctor. At least one third of common symptoms do not have a clear-cut, disease-based explanation. History and physical examination alone contribute 73% to 94% of the diagnostic information. The patient's history alone yields 75% of the diagn...
Source: Clinical Cases and Images - November 17, 2014 Category: Journals (General) Tags: Health News of the Day Source Type: news

Another Pipeline Diabetes Drug Looks Beneficial
(MedPage Today) -- The investigational SGLT2 inhibitor remogliflozin showed benefits for glucose lowering in type 2 diabetes. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - November 5, 2014 Category: Cardiology Source Type: news

U.S. FDA Approves Once-Daily XIGDUO(TM) XR Tablets for Adults with Type 2 Diabetes
First U.S. approval for once-daily tablet combining SGLT2 inhibitor and metformin HCl extended-release WILMINGTON, Del.--(Healthcare Sales & Marketing Network)--AstraZeneca (AZN) today announced that the U.S. Food and Drug Administration has approved on... Biopharmaceuticals, Endocrinology, FDAAstraZeneca, XIGDUO XR, dapagliflozin, metformin, diabetes (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 30, 2014 Category: Pharmaceuticals Source Type: news

Pilot Study Explores Dapagliflozin Use in Type 1 DiabetesPilot Study Explores Dapagliflozin Use in Type 1 Diabetes
Already approved for use in type 2 diabetes, the SGLT2 inhibitor dapagliflozin is tested in a pilot trial in patients with type 1 diabetes along with insulin therapy. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - October 8, 2014 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Multiple Benefits With New Diabetes Drugs
VIENNA (MedPage Today) -- The newest class of diabetes medications, the SGLT2 inhibitors, were good at controlling HbA1c and offered additional benefits of weight loss and greater reductions in blood pressure, researchers said here. (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - September 18, 2014 Category: Primary Care Source Type: news

Empagliflozin Useful Second-Line for Diabetes vs GlimepirideEmpagliflozin Useful Second-Line for Diabetes vs Glimepiride
The SGLT2 inhibitor empagliflozin provided favorable results at 2 years compared with the sulfonylurea glimepiride when used as second-line therapy after metformin in diabetes. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - September 17, 2014 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Cardiovascular Outcome Trial of EmpagliflozinCardiovascular Outcome Trial of Empagliflozin
Is this SGLT2 inhibitor safe in patients at high risk for heart disease? This trial will find out. Cardiovascular Diabetology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 25, 2014 Category: Consumer Health News Tags: Diabetes & Endocrinology Journal Article Source Type: news

Canagliflozin/Metformin Combo Finally Approved in USCanagliflozin/Metformin Combo Finally Approved in US
First approval of an SGLT2 inhibitor/metformin combination in the US is Janssen's canagliflozin. FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 11, 2014 Category: Consumer Health News Tags: Diabetes & Endocrinology News Alert Source Type: news

Diabetes: Drug duo helps best, study finds
Metformin and SGLT2 inhibitors together reduce the blood sugar levels of diabetics considerably more effectively than either drug alone. Scientists report that this is due to a synergetic mechanism. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - August 4, 2014 Category: Science Source Type: news

Diabetes: A duo helps better
(Helmholtz Zentrum München - German Research Center for Environmental Health) Metformin and SGLT2 inhibitors together reduce the blood sugar levels considerably more effectively than either drug alone. Scientists from the Helmholtz Zentrum München, partner in the German Center for Diabetes Research, report in the journal 'Diabetes' that this is due to a synergetic mechanism. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 4, 2014 Category: Global & Universal Source Type: news