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Supernus SPN-812 Phase IIa U.S. clinical trial in ADHD meets primary endpoints

Supernus Pharmaceuticals, Inc. today announced that its Phase IIa U.S. clinical trial of SPN-812 in adults for the treatment of attention deficit hyperactivity disorder (ADHD) met the primary endpoints of safety and tolerability, and showed statistically significant median reduction versus placebo in both investigator-rated and patient-rated ADHD symptom scores.

11 Mar 2011

Sweden's TLV confirms reimbursement for Qutenza patch for treatment of peripheral neuropathic pain

Patients in Sweden living with peripheral neuropathic pain are set to gain access to a new treatment option which can provide pain relief for up to three months following a single 30- or 60-minute application. The new treatment patch uses capsaicin - the substance found in chilli peppers which gives them their 'heat' - to change the function of pain sensing nerves in the area of skin affected.

1 Mar 2011

Researchers to develop automation system for sedation control in hospital ICUs

Researchers at the Georgia Institute of Technology and the Northeast Georgia Medical Center are one step closer to their goal of automating the management of sedation in hospital intensive care units. They have developed control algorithms that use clinical data to accurately determine a patient's level of sedation and can notify medical staff if there is a change in the level.

14 Feb 2011

Simple hTERT analysis may provide useful prognostic tool in advanced non-small cell lung cancer

High levels of circulating DNA may indicate faster progression of lung cancer and lower overall survival, according to a study published in the February edition of the Journal of Thoracic Oncology, the official publication of the International Association for the Study of Lung Cancer (IASLC).

1 Feb 2011

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc has received approval from the US Food and Drug Administration for Abstral. Abstral is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain.

10 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

UCB's Cimzia and Centocor's Simponi penetrate first line biologic position in RA

In its recently released annual 2010 update, ChartTrends®: Biologics in Rheumatoid Arthritis, BioTrends Research Group, Inc. finds that newer biologic agents such as UCB's Cimzia and Centocor OrthoBiotech's Simponi, although lagging in overall market share, have begun to penetrate the first line biologic position primarily at the expense of Pfizer/Amgen's Enbrel and Abbott's Humira.

21 Dec 2010

BioTrends releases annual syndicated publication of CKD-ND patient charts

BioTrends Research Group, Inc. released ChartTrends: Bone and Mineral Metabolism in Chronic Kidney Disease Non-Dialysis (CKD-ND), an annual syndicated publication based on patient and laboratory data collected from over 1,000 U.S.

30 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Cheetah Medical launches new NICOM System with integrated Pulse Oximetry functionality in Europe

Cheetah Medical today announced the European launch of its new NICOM(R) System which offers an integrated Pulse Oximetry functionality (OxiMax(R) Covidien plc). In addition to core hemodynamic parameters including Cardiac Output (CO), Stroke Volume (SV), Noninvasive Blood Pressure (NIBP), Total Peripheral Resistance (TPR) and Stroke Volume Variation (SVV), the new system provides a new important parameter, Oxygen Delivery Index (DO2I).

15 Oct 2010

Archimedes publishes results from FPNS Phase III clinical study for breakthrough cancer pain

Archimedes Pharma, an emerging specialty pharma company focused on oncology, pain, neurology and critical care sectors, today announced publication of results from a Phase III, long-term safety, tolerability and consistency of effect, clinical study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

13 Oct 2010

Neupro improves quality of life in Parkinson's disease patients

People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

4 Oct 2010

Study demonstrates rufinamide therapy is effective in reducing partial seizure frequency

Researchers from the Arkansas Epilepsy Program found treatment with rufinamide results in a significant reduction in seizure frequency compared with placebo, for patients with uncontrolled partial-onset seizures (POS).

1 Oct 2010

Phase III trial results of lixisenatide for type 2 diabetes presented at 46th EASD

Sanofi-aventis announced today the first Phase III results of the GetGoal clinical trial program assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, as monotherapy in patients with type 2 diabetes. These results were presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 2010

Relypsa completes $70M Series B financing

Relypsa, Inc., a biopharmaceutical company developing non-absorbed polymeric drugs, today announced the completion of a Series B financing totaling $70 million. OrbiMed Advisors, LLC, led the financing with participation from existing Relypsa investors New Leaf Venture Partners, 5AM Ventures, Delphi Ventures, Sprout Group and Mediphase Venture Partners.

13 Sep 2010

Halozyme initiates Ultrafast Insulin combination Phase 2 studies with rHuPH20

Halozyme Therapeutics, Inc. today announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®.

2 Sep 2010

PolyMedix's PMX-60056 Phase 1B/2 dose-ranging clinical study for heparin reversal meets study endpoints

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B/2 dose-ranging clinical study with PMX-60056, a synthetic small-molecule designed to reverse heparin and low molecular weight heparin anticoagulants.

11 Aug 2010

Morphine plus oxycodone IV combination exhibits improved analgesia, tolerability compared to IV morphine

QRxPharma Limited announced today positive results of its Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of its IV (intravenous) formulation of morphine plus oxycodone versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. The main findings demonstrated that QRxPharma's formulation of MoxDuo IV resulted in fewer side effects and offered better pain relief than morphine alone.

9 Aug 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010