Archive for March, 2014

NICE seeks views on how it assesses drugs and other technologies for the NHS

Posted on March 31st, 2014 by Valorem Life Sciences

The National Institute for Health and Care Excellence has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS.

NICE assesses the clinical and cost effectiveness of new technologies to help ensure that patients have access to effective treatments and the NHS makes the best use of its resources.

The new proposals include ways to take into account more systematically and explicitly the severity of a disease, as well as the effect that diseases and conditions have on our capacity to engage in society.

The chief executive of NICE, Sir Andrew Dillon, explained:

“These proposed changes to the way we value new treatments will add further clarity to our recommendations and enable our independent advisory committees to explore more fully the potential these treatments have to improve outcomes for patients.”

Source: Pharmiweb

Ipsen SA announces positive results from phase IIa clinical study of Dysport

Posted on March 18th, 2014 by Valorem Life Sciences

Ipsen SA:Positive results from phase IIa clinical trial assessing Dyspor in treatment of Neurogenic Detrusor Overactivity (NDO) in patients with urinary incontinence not adequately managed by anticholinergics. Results show that treatment with Dysport was associated with mean reduction from baseline of urinary incontinence episodes greater than 75 pct, 12 weeks after the injection, regardless of how drug is administered. These results were achieved with single dose of Dysport 750 Units injected in either 15 or 30 sites in detrusor muscle. Efficacy was confirmed by improvement in urodynamic parameters and quality of life. Safety profile observed in study is consistent with safety profile expected in this indication.

Source: Reuters

FDA approves AZ’s Bydureon® Pen for type 2 diabetes

Posted on March 3rd, 2014 by Valorem Life Sciences

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the BYDUREON® Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. BYDUREON should not be used for treatment of patients with type 1 diabetes or diabetic ketoacidosis. BYDUREON is not recommended as first-line therapy for patients who have inadequate glycaemic control on diet and exercise. BYDUREON is not a substitute for insulin. The concurrent use of BYDUREON with insulin has not been studied and is not recommended.

BYDUREON is the first and only once-weekly medicine for adults with type 2 diabetes. The BYDUREON Pen is a pre-filled, single-use pen injector, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The BYDUREON Pen contains the same formulation and dose as the original BYDUREON single-dose tray, providing the same continuous release of exenatide.

“We’re pleased to receive approval for the BYDUREON Pen, which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a pre-filled device,” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca. “We are committed to addressing the needs of adults with type 2 diabetes, including ongoing research to develop new treatments and methods of delivery.”

Source: Pharmiweb