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FDA recommends dabigatran etexilate to prevent stroke in AF patients

The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee today voted 9 to 0 in favour of recommending dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AF).

21 Sep 2010

USP PET results qualify Apricus Bio's NexACT as anti-microbial preservative

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that results from a United States Pharmacopeia Preservative Efficacy Test (USP PET) qualified NexACT as an anti-microbial preservative. The results show that NexACT was effective in killing more than 23 strains of bacteria, fungus and mold, well beyond the requirements for passing the USP PET.

21 Sep 2010

Study: Capecitabine with concurrent radiation is effective for treating gastric cancer

Gastric cancer is a major cause of cancer deaths in the world. The outcome of large gastric tumors and those with lymph node involvement remains poor after surgical resection. The optimal adjuvant therapy after surgical resection remains to be determined.

21 Sep 2010

FDA Advisory Committee recommends approval of dabigatran etexilate for stroke prevention in AFib patients

The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee today voted 9 to 0 in favor of approving dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). An estimated 2.3 million Americans have AFib and the prevalence is expected to increase 2.5 fold to 5.6 million by 2050, reflecting the growing population of elderly individuals.

21 Sep 2010

FDA approves Medtronic's Integrity Coronary Stent System

Delivering another innovation for interventional cardiology, Medtronic, Inc.,announced today the U.S. Food and Drug Administration (FDA) approval of the Integrity Coronary Stent System. The new platform for Medtronic's coronary stents, including the Integrity bare-metal stent, is based on an advance in biomedical engineering called continuous sinusoid technology that enables the exploration of other breakthrough device concepts such as a polymer free drug filled stent.

21 Sep 2010

Corindus announces clinical results of CorPath 200 System

Corindus Vascular Robotics announced the results of the first clinical study of the CorPath 200 System and invites attendees of the Transcatheter Cardiovascular Therapeutics (TCT) 2010 conference (September 21-25 in Washington, DC) to experience firsthand the CorPath 200 System.

21 Sep 2010

BioNeutral third quarter revenue increases to $15,500

BioNeutral Group Inc., a specialty chemical technology-based life science company, today announced financial results for the third quarter and nine-month period ended July 31, 2010.

21 Sep 2010

Micromet initiates MT103 phase 2 trial in adult ALL patients

Micromet, Inc. today announced the initiation of a phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE antibodies, designed to harness the body's T cells to kill cancer cells.

20 Sep 2010

$Neovasc commences enrollment in Reducer trial for refractory angina$

Neovasc commences enrollment in Reducer trial for refractory angina

Neovasc Inc., a developer of novel technologies used to treat vascular disease, today announced that the first patients have been enrolled in its COSIRA trial designed to assess the clinical efficacy of the Neovasc Reducer(TM) product for the treatment of refractory angina. The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a multicenter, sham-controlled, randomized, double-blinded study of the Reducer that is expected to enroll up to 124 patients.

20 Sep 2010

Dapagliflozin added to glimepiride therapy reduces HbA1c in adult type 2 diabetes patients

Bristol-Myers Squibb Company and AstraZeneca today announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in glycosylated hemoglobin levels (HbA1c) in adult patients with type 2 diabetes compared to glimepiride alone.

20 Sep 2010

Sanofi-aventis releases Lantus(R) study results for type 2 diabetes

Sanofi-aventis announced today results of two studies presented at the European Association for the Study of Diabetes (EASD) 46th Annual Meeting in Stockholm, Sweden.

20 Sep 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

Chelsea Therapeutics' Phase III NORTHERA Study 301 meets primary endpoint

Chelsea Therapeutics International, Ltd. announced that preliminary analyses of its Phase III NORTHERA™ Study 301 met its primary endpoint. Treatment with Northera provided clinically meaningful and statistically significant improvement.

20 Sep 2010

Oxygen Biotherapeutics announces CRADA Agreement amendment

Oxygen Biotherapeutics, Inc. today announced it has amended an existing Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC) to include preclinical trials using swine models to assess the safety and efficacy of Oxygen Biotherapeutics' proprietary Oxycyte perfluorocarbon emulsion (PFCE) for spinal cord injury (SCI) due to decompression sickness (DCS), and for hemorrhagic shock.

20 Sep 2010

Researchers discover HIV-1 resists AZT drug

Rutgers researchers have discovered how HIV-1, the virus that causes AIDS, resists AZT, a drug widely used to treat AIDS. The scientists, who report their findings in Nature Structural & Molecular Biology, believe their discovery helps researchers understand how important anti-AIDS treatments can fail and could help AIDS researchers develop more effective treatment for the disease.

20 Sep 2010

$ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study$

ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study

Medtronic, Inc. announced that data from a multicenter, prospective, randomized, blinded, feasibility trial published today show promise for occipital nerve stimulation for treating medically refractory chronic migraines and support the need for further controlled study of the treatment. The study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine, included severely debilitated patients who had regularly experienced 15 or more headache days per month that were not responsive to currently available medical therapies.

18 Sep 2010

FDA grants Optovue 510(k) clearance on Normative Database for RTVue OCT device

Optovue, the company that launched the first FDA cleared fourier/spectral domain OCT in the U.S., announced that it has received 510(k) clearance on its Normative Database ("NDB") for the RTVue OCT device.

18 Sep 2010

Emergent BioSolutions signs contract with HHS to develop rPA anthrax vaccine

Emergent BioSolutions Inc. announced today that it has signed a contract, valued at up to $186.6 million, with the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services, for the development of a recombinant protective antigen anthrax vaccine.

18 Sep 2010

Elixir Medical commences enrollment in EXCELLA BD trial for DESyne BD Novolimus Eluting CSS

Elixir Medical Corporation, a developer of product platforms that combine innovative medical devices with potent pharmaceuticals for site-specific therapies, announced the initiation of patient enrollment in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir's next generation Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating, the Elixir DESyne BD Novolimus Eluting CSS.

18 Sep 2010

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Boehringer Ingelheim today announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread.

18 Sep 2010