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Clinical study results demonstrate the efficacy of AFRESA inhalation powder

AFRESA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

2 Oct 2009

Results from the BLOSSOM trial announced by Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported today positive, highly significant top-line results from the BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trial.

18 Sep 2009

Phase III clinical trial results of DAR-31 published

Gilead Sciences, Inc. today announced the publication of data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.

14 Sep 2009

The Kyoto Heart study shows positive effect of valsartan on cardiovascular outcome

The KYOTO HEART Study, which took place in Japan between January 2004 and January 2009, shows that the addition of valsartan to conventional antihypertensive treatment to improve blood pressure control is associated with an improved cardiovascular outcome in Japanese hypertensive patients at high risk of CVD events.

2 Sep 2009

Study reveals that valsartan prevents cardiovascular events in high-risk hypertensive Japanese patients

2 Sep 2009

FDA approves Extavia for multiple sclerosis

The US Food and Drug Administration (FDA) has approved Extavia(R) (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

17 Aug 2009

Low-income patients with obstructive sleep apnea are less likely to start CPAP therapy

A study in the April 1 issue of the journal SLEEP demonstrates that low socioeconomic status independently predicts the poor acceptance of continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea, and patients with higher incomes are more likely to begin treatment.

1 Apr 2009

FDA approves Symbyax for treatment-resistant depression

The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company has announced.

23 Mar 2009

Simplified treatment for sleep apnea

Diagnosing and treating obstructive sleep apnea may soon become much less expensive and arduous, thanks to new research showing that a simplified program using experienced nurses, home ambulatory diagnosis and auto-titrating continuous positive airway pressure (CPAP) machines to titrate CPAP pressures is not inferior to the traditional model which relies on specialist physicians and sleep studies.

8 Mar 2009

Lilly receives complete response letter for Olanzapine LAI for treatment of schizophrenia

Eli Lilly and Company has announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults.

7 Jan 2009

Halozyme Therapeutics starts phase 2 trial of insulin with rHuPH20 in type 1 diabetes

Halozyme Therapeutics, Inc. today announced it has started a Phase 2 study of proprietary recombinant human hyaluronidase enzyme (rHuPH20) co-formulations with Humulin R (regular insulin human injection) and with Humalog (insulin lispro) in Type 1 diabetic patients.

3 Nov 2008

Adalat XL Plus approved in Canada

Bayer Inc. announced that Health Canada has granted a Notice of Compliance (NOC) for Adalat XL Plus, a co-packaging of Adalat XL and Aspirin 81mg.

12 Aug 2008

FDA approves PRISTIQ for the treatment of adult patients with major depressive disorder

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the U.S. Food and Drug Administration (FDA) has approved PRISTIQ (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD).

3 Mar 2008

BioMarin Pharmaceutical announces FDA approval for Kuvan

BioMarin Pharmaceutical Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Kuvan(TM) (sapropterin dihydrochloride) Tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU).

14 Dec 2007

Positive results from trial of investigational anti-epilepsy drug Brivaracetam

UCB has announced data demonstrating that anti-epileptic drug (AED) brivaracetam, with the proposed trade name Rikelta, administered as an adjunctive treatment in adults with refractory epilepsy with partial onset seizures, significantly reduced seizure frequency and had a side-effect profile comparable to placebo.

4 Dec 2007

BioMarin files investigational NDA for PEG-PAL for the treatment of phenylketonuria

BioMarin Pharmaceutical Inc. has announced that it has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for PEG-PAL (Poly Ethylene Glycol-Phenylalanine Ammonia Lyase), formerly known as Phenylase, for the treatment of phenylketonuria (PKU).

27 Nov 2007

Seroquel XR tablets approved in Netherlands for the treatment of schizophrenia

AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved Seroquel XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.

29 Aug 2007

Nasal insufflation for sufferers of sleep apnea

Researchers at Johns Hopkins University have found that symptoms in patients with obstructive sleep apnea and hypopnea can be significantly reduced through treatment with nasal insufflation (TNI), using a nasal cannula to deliver warm, humidified air at a high flow rate.

17 Jul 2007

Solvay Pharmaceuticals submits supplemental NDA for AndroGel

Solvay Pharmaceuticals, Inc., has announced that it submitted a supplemental New Drug Application (sNDA) for AndroGel (testosterone gel) 1% CIII to the U.S. Food and Drug Administration (FDA) for treatment in male adolescents ages 13-17 years old with primary or secondary hypogonadism.

17 Jun 2007

Group based cognitive behavioural therapy helps overcome major CPAP problem

For the first time, a group based cognitive behavioural therapy (CBT) intervention has been demonstrated to markedly increase acceptance and adherence to CPAP treatment for sufferers of obstructive sleep apnea (OSA).

16 May 2007