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Seaside Therapeutics commences STX209 Phase 2b study in autism spectrum disorders

Seaside Therapeutics, Inc. announced today the initiation of a randomized, double-blind, placebo-controlled Phase 2b study to evaluate the effects of STX209 (arbaclofen) on social impairment in children, adolescents and adults with autism spectrum disorders.

21 Jun 2011

Researchers uncover protein structural clues associated to PD

Researchers at the Keck School of Medicine of the University of Southern California (USC) have uncovered structural clues about the protein linked to Parkinson's disease (PD), which ultimately could lead to finding a cure for the degenerative neurological disorder.

18 Jun 2011

Alkermes commences ALKS 5461 phase 1/2 study for treatment-resistant depression

Alkermes, Inc. today announced the initiation of a phase 1/2 study of ALKS 5461 for treatment-resistant depression (TRD). ALKS 5461 is the combination of ALKS 33, a proprietary opioid modulator, and buprenorphine. TRD, which is also known as refractory depression, refers to depressive episodes that are not adequately controlled by standard antidepressant therapy.

15 Jun 2011

FDA approves Abbott's CREON capsules for treatment of EPI due to cystic fibrosis

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.

15 Jun 2011

Abbott’s CREON receives FDA approval for infant-specific dose

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The CREON 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA. This new option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing.

14 Jun 2011

ACT's TEMPASURE cardiac ablation catheter receives CE Mark

Advanced Cardiac Therapeutics, Inc., a developer of innovative temperature-sensing cardiac ablation systems, today announced that the company has received CE Mark (Conformité Européenne) clearance for its TEMPASURE™ cardiac ablation catheter. The TEMPASURE system is the world's first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.

8 Jun 2011

Positive data from Biogen Idec's AVONEX clinical trial on multiple sclerosis presented at CMSC 2011

Biogen Idec today announced the findings from a randomized, multicenter, dose-blinded clinical trial that evaluated the effect of AVONEX dose titration, or gradual dose escalation, on flu-like symptoms associated with the therapy.

6 Jun 2011

Azilsartan medoxomil-CLD phase 3 study results in systolic blood pressure presented at ASH 2011

Takeda Global Research & Development Center, Inc. U.S., today announced results from three phase 3 studies of the investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone.

24 May 2011

Positive results from Relypsa RLY5016 Phase 2 trial to be presented at American Society of Hypertension meeting

Relypsa, Inc. today announced the presentation of positive results from a Phase 2 clinical trial of the company's lead compound, RLY5016, a non-absorbed oral potassium binder being developed as a treatment for hyperkalemia (elevated serum potassium levels).

23 May 2011

Takeda, Affymax announce additional peginesatide Phase 3 study results in dialysis patients

Affymax, Inc. and Takeda Pharmaceutical Company Limited, today announced results of additional analyses from two Phase 3 studies of the investigational agent, peginesatide in chronic renal failure patients on dialysis with anemia.

29 Apr 2011

Biodel selects BIOD-105, BIOD-107 recombinant human insulin formulations for clinical testing, development

Biodel Inc. announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.

14 Mar 2011

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