Diabetes Contender Faces Second FDA Panel
(MedPage Today) -- An FDA advisory committee will be paying close attention to updated cardiovascular safety analyses of the investigational type 2 diabetes drug dapagliflozin (Farxiga), which has already once been denied approval by the agency. (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 11, 2013 Category: Cardiology Source Type: news
FDA staff cautious on AstraZeneca, Bristol diabetes drug
LONDON (Reuters) - U.S. Food and Drug Administration staff said on Tuesday they were wary about the benefits versus the risks of AstraZeneca and Bristol-Myers Squibb's new diabetes drug dapagliflozin. (Source: Reuters: Health)
Source: Reuters: Health - December 10, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
Dapagliflozin/Metformin Combo Nears EU Approval for DiabetesDapagliflozin/Metformin Combo Nears EU Approval for Diabetes
The first product combining metformin with an SGLT2 inhibitor, dapagliflozin, has been granted a positive opinion by the European Medicines Agency for use in type 2 diabetes. Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - November 22, 2013 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news
FDA Accepts NDA Resubmission of Diabetes Drug Dapagliflozin FDA Accepts NDA Resubmission of Diabetes Drug Dapagliflozin
Dapagliflozin now looks set to be in a race with empagliflozin to become the second SGLT-2 inhibitor to reach the US market for the treatment of adults with type 2 diabetes. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 26, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
AstraZeneca Wins U-Turn On Diabetes Drug, Meet Them At Diabetes 2013, 1-2 October, London, United Kingdom
In final draft guidance published in recent weeks, NICE has recommended dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) for some people with type 2 diabetes. The agency changed its position on the drug after requesting further information from its manufacturers. NICE said it expected to publish final guidance on Forxiga in June 2013 "We are pleased to recommend dapagliflozin for some people with type 2 diabetes. It is a serious problem in the UK and dapagliflozin provides another treatment option for some people with this condition... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 17, 2013 Category: Consumer Health News Tags: Conferences Source Type: news
AstraZeneca Wins U-Turn On Diabetes Drug�, Meet Them At Diabetes 2013, 1-2 October, London, United Kingdom
In final draft guidance published in recent weeks, NICE has recommended dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) for some people with type 2 diabetes. ��The agency changed its position on the drug after requesting further information from its manufacturers. NICE said it expected to publish final guidance on Forxiga in June 2013 "We are pleased to recommend dapagliflozin for some people with type 2 diabetes. It is a serious problem in the UK and dapagliflozin provides another treatment option for some people with this condition... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 17, 2013 Category: Consumer Health News Tags: Conferences Source Type: news
Dapagliflozin For Diabetes: No Added Benefit Proven
Manufacturer's dossier did not contain suitable data for any therapeutic indication Dapagliflozin (trade name: Forxiga) has been approved in Germany since November 2012 for the treatment of type 2 diabetes mellitus. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG) the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the current standard therapy... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 10, 2013 Category: Consumer Health News Tags: Diabetes Source Type: news
Added benefit of dapagliflozin is not proven
(Institute for Quality and Efficiency in Health Care) In an early benefit assessment IQWiG examined whether the drug dapagliflozin offers an added benefit over the current standard therapy for people with type 2 diabetes. However, no such added benefit can be derived from the dossier because the drug manufacturer did not present any suitable data for this comparison. This is the conclusion of a dossier assessment by the German IQWiG, Cologne, which was published in March 2013 and for which an English-language extract is now available. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - June 6, 2013 Category: Global & Universal Source Type: news
UK Funding for Forxiga Inches CloserUK Funding for Forxiga Inches Closer
The UK body NICE has issued draft guidance saying it will likely fund the new SGLT-2 inhibitor dapagliflozin for some patients with type 2 diabetes, in combination with metformin or insulin. WebMD Health News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 4, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
NICE publishes positive Final Appraisal Determination for dapagliflozin
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) for Bristol-Myers Squibb and AstraZeneca’s, first-in-class Type 2 diabetes medicine FORXIGA® (dapagliflozin). (Source: Pharmacy Europe)
Source: Pharmacy Europe - June 4, 2013 Category: Drugs & Pharmacology Source Type: news
What The Pfizer-Merck Diabetes Deal Teaches About Today's Pharma R&D
Earlier today, Pfizer and Merck announced a new partnership in the area of diabetes drug research. The companies will join forces to develop and commercialize ertugliflozin (PF-04971729), an oral sodium glucose cotransporter (SGLT2) inhibitor for type 2 diabetes which is about to begin phase 3 studies. SGLT2 inhibitors are a new class of antidiabetic drugs, the first of which, J&J’s Invokana (generic name: canagliflozin), was approved by the FDA on March 29th. This is a very competitive field of research as evidenced by the number of companies with compounds in late development, including Lilly/Boehringer’s em...
Source: Forbes.com Healthcare News - April 29, 2013 Category: Pharmaceuticals Authors: John LaMattina Source Type: news
NICE issues Appraisal Consultation Document on dapagliflozin for type 2 diabetes and requests more information from the manufacturer
Source: NICE
Area: News
The National Institute for Health and Clinical Excellence (NICE) has issued for consultation an Appraisal Consultation Document (ACD) on the use of dapagliflozin for type 2 diabetes.
The following preliminary recommendations have been made:
. The Committee is minded not to recommend dapagliflozin in combination therapy for treating type 2 diabetes.
. The Committee recommends that NICE requests further clarification from the manufacturers, which should be made available for the second Appraisal Committee meeting on the 5th March 2013
The consulta...
Source: NeLM - News - February 1, 2013 Category: Drugs & Pharmacology Source Type: news
Bristol-Myers Squibb Reports Fourth Quarter and Full Year 2012 Financial Results
Significant Regulatory Approvals
Gained in Fourth Quarter
Eliquis® Approved in the
U.S., Europe, Japan, Canada and South Korea to Reduce the Risk of
Stroke in Patients with Nonvalvular Atrial Fibrillation
Forxiga® Approved in Europe
for... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 24, 2013 Category: Pharmaceuticals Source Type: news
Scottish Medicines Consortium issues guidance for use of Forxiga as type two diabetes therapy
Scottish Medicines Consortium (SMC) has issued advice that enables NHS Boards to allow physicians to prescribe Forxiga (dapagliflozin) as first-in-class type 2 diabetes treatment. (Source: Drug Development Technology)
Source: Drug Development Technology - January 16, 2013 Category: Pharmaceuticals Source Type: news
SMC accepts dapagliflozin (ForxigaT) for restricted use in adults patients with type 2 diabetes mellitus
Source: Scottish Medicines Consortium (SMC)
Area: Evidence > Drug Specific Reviews
The Scottish Medicines Consortium has accepted dapagliflozin (ForxigaT) for restricted use within NHS Scotland in adults patients with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
The SMC states that dapagliflozin is restricted to use as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate g...
Source: NeLM - Drug Specific Reviews - January 15, 2013 Category: Drugs & Pharmacology Source Type: news
