ADHD :: Daytrana, methylphenidate transdermal system provides individualized ADHD symptom management

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced that its Attention Deficit Hyperactivity Disorder (ADHD) patch, DAYTRANA tm (methylphenidate transdermal system), has significant efficacy in reducing the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours. The ability to remove the patch earlier than the recommended nine-hour wear time allows physicians the opportunity to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping. These phase IIIb clinical trial results were reported today at a major scientific and educational meeting of child and adolescent psychiatrists in San Diego, Calif.

ADHD :: Lisdexamfetamine dimesylate in ADHD phase 3 data presented

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that their investigational ADHD treatment, lisdexamfetamine dimesylate (also known as NRP104 or LDX), yielded a 60 percent improvement in the primary rating scale scores for symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 12 years who received six months of treatment in an open-label phase III study. Results also demonstrated that at 6 months, 95 percent of children taking lisdexamfetamine dimesylate (NRP104/LDX) produced a “much improved” or “very much improved” rating on the Clinical Global Impressions ? Improvement score. These results were presented last weekend at a national meeting of child and adolescent psychiatrists.

Osteosarcoma :: IDM Pharma’s Junovan, mifamurtide in the treatment of osteosarcoma

IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted an electronic New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Junovan(TM) (mifamurtide for injection), requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple agent chemotherapy.

Ulcerative Colitis :: Adherence to ulcerative colitis medications is not affected by drug formulation or dosing regimen

Poor adherence to medication is a recognized medical problem, costing an estimated $100 billion a year in the United States.(i) New data show that while there is a steady decline in adherence to medications for ulcerative colitis (UC), drug formulation and the number of pills taken each day do not affect long-term adherence. The data were presented today at the annual scientific meeting of the American College of Gastroenterology by University of Chicago researcher Sunanda Kane, M.D.

Crohn’s Disease :: Promising results in tough-to-treat crohn’s disease patients

Abbott announced results from a study showing HUMIRA? (adalimumab) induced significantly higher rates of clinical remission compared to placebo in patients with moderately to severely active Crohn’s disease who lost response to, or were intolerant to, infliximab therapy. The data is being presented simultaneously at the American College of Gastroenterology (ACG) annual meeting in Las Vegas and the United European Gastroenterology Week (UEGW) in Berlin.

Leptospirosis :: Leptospirosis diagnosed after a fishing holiday in France

Leptospirosis has been diagnosed clinically in two men recently returned from a fishing holiday at a resort in the Picardie region of north-east France. One case has since been serologically confirmed. Both patients were at the same resort at the same time (mid-September), and became unwell about one week after their return to the United Kingdom.

Health :: Glivec, imatinib approved for five rare life threatening disorders

In another important milestone, Glivec? (imatinib) has received US regulatory approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders. With today’s decision, and in only five years, Glivec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.

HIV :: REYATAZ, atazanavir sulfate for Adults With HIV-1 Infection

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new 300 mg single capsule formulation of REYATAZ? (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy. Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the REYATAZ 300 mg single capsule formulation can replace two REYATAZ 150 mg capsules for: patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate, and patients who have never taken anti-HIV medicines that require SUSTIVA? (efavirenz) as part of their anti-HIV drug regimen. The REYATAZ single capsule formulation will be available in the United States within seven business days.

Diabetes :: JANUVIA, sitagliptin phosphate – the First and Only DPP-4 Inhibitor for Type 2 Diabetes

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) approved JANUVIA (sitagliptin phosphate), the first and only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. JANUVIA has been approved as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise is not enough. The recommended dose of JANUVIA is 100 mg once daily. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

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