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Despite FDA action, Deston still believes Auralgan as a safe and effective drug product

Deston Therapeutics LLC announced today that it is currently exploring its options to respond to a recent seizure of its Auralgan Otic Solution by the Federal Government and that it still believes that Auralgan is a safe and effective drug product.

28 Feb 2011

First patient treated in KUR-023 pilot clinical trial to assess safety and efficacy of product candidate

Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has treated the first patient in a pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate.

28 Feb 2011

FDA approves GSK's PROMACTA to treat rare blood disorder

GlaxoSmithKline today announced that the United States Food and Drug Administration granted full approval for PROMACTA, an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

27 Feb 2011

Phase III trial results: Erlotinib has comparable efficacy to chemotherapy with better tolerability against lung cancer

The targeted cancer drug erlotinib has comparable efficacy to chemotherapy, and is better tolerated, in hard-to-treat cases where a patient's cancer has progressed quickly after treatment with first-line therapy, the results of a new phase III trial show.

27 Feb 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Avastin debate spills over until June FDA hearing

The U.S. Food and Drug Administration have granted Roche a hearing in June to defend the cancer treatment Avastin. The hearing would examine the effectiveness of the drug in breast cancer.

27 Feb 2011

Well-being in adolescence linked to life satisfaction in adulthood

Being a 'happy' teenager is linked to increased well-being in adulthood, new research finds.

25 Feb 2011

Medwell commits $2,000,000 investment in Mimetogen

Medwell Capital Corp. today announced that it has committed to invest up to $2,000,000 in Mimetogen Pharmaceuticals Inc. ("Mimetogen"), a privately-held, clinical-stage company developing a treatment for dry eye disease. Medwell Capital participated in a Series B equity financing with existing Mimetogen investors, iNovia Capital, MSBi Valorisation and VIMAC Milestone Medica.

25 Feb 2011

Enrollment commences in NORDIC implantable cardioverter defibrillator clinical trial

BIOTRONIK SE & Co. KG announced today the start of the NORDIC ICD clinical trial. The first implantable cardioverter defibrillator (ICD) patients were enrolled by its coordinating clinical investigator, Prof. Dr. Dietmar Bänsch at the University Hospital of Rostock and the investigator Dr. Stefan Kuster at the DRK Hospital of Mölln/Ratzeburg.

25 Feb 2011

Enobia completes patient enrollment in ENB-0040 Phase II study for HPP

Enobia Pharma Inc., today announced that it has successfully completed enrollment in its Phase II study of ENB-0040, a bone targeted enzyme replacement therapy being investigated in adolescents and adults with hypophosphatasia, a serious, rare metabolic bone disorder.

25 Feb 2011

$MHI begins patient enrollment for new device to treat refractory angina$

MHI begins patient enrollment for new device to treat refractory angina

The interventional cardiology team at the Montreal Heart Institute recently began patient enrolment for a new device, the Neovasc Reducer, designed to treat patients suffering from refractory angina.

25 Feb 2011

HRS invites NewCardio to present CardioBip system clinical study results at Annual Scientific Meeting

NewCardio, Inc., a cardiovascular diagnostic solutions developer, announced today that the Company has been invited by the Heart Rhythm Society to present results of a recent clinical study showing that recurrent atrial fibrillation was accurately and timely detected in patients who used CardioBip for daily monitoring following catheter ablation procedures.

25 Feb 2011

BioCryst receives HHS contract to complete peramivir Phase 3 study in patients with influenza

BioCryst Pharmaceuticals, Inc. announced that it has been awarded a $55.0 million contract modification by the U.S. Department of Health & Human Services intended to fund to completion the Phase 3 development of its neuraminidase inhibitor, intravenous peramivir, for the treatment of patients hospitalized with influenza.

25 Feb 2011

Feasibility study to test scalp cooling device in breast cancer patients undergoing chemotherapy

A feasibility study to test the use of a scalp cooling device that breast cancer patients will wear while undergoing chemotherapy treatment will be conducted at Wake Forest University Baptist Medical Center. This will be part of the first significant study of the medical device in the United States.

25 Feb 2011

Study: More effective therapies needed for diabetes patients with ESRD

Despite significant advances in kidney care over the past 20 years, efforts to improve therapy for type 1 diabetes patients with kidney dysfunction remain unsuccessful, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology. The results suggest that more effective therapies are needed for these patients.

24 Feb 2011

PolyMedix completes PMX-30063 Phase 1 exposure-escalation clinical study to treat Staph infections

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, today announced the successful completion of a Phase 1 exposure-escalation clinical study with its synthetic defensin-mimetic antibiotic, PMX-30063.

24 Feb 2011

BioSante completes patient enrollment in LibiGel Phase III trial for treatment of FSD

BioSante Pharmaceuticals, Inc. today announced that enrollment of subjects in the first of two pivotal Phase III LibiGel safety and efficacy trials has been completed.

24 Feb 2011

Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced the companies have begun enrolling patients in a Phase 3 randomized, double-blind, placebo-controlled trial evaluating Nexavar tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer.

24 Feb 2011

Positive results from Vertex VX-770 Phase 3 STRIVE study in patients with CF

Vertex Pharmaceuticals Incorporated today announced positive results from the Phase 3 STRIVE study of VX-770, an oral medicine in development that targets the defective protein that causes cystic fibrosis.

24 Feb 2011

G-CSF treatment improves inadequate endometrium during IVF cycles

During in vitro fertilization cycles, treatment with a medication called granulocyte-colony stimulating factor significantly improves inadequate endometrium, according to a report published electronically on February 15 in Fertility and Sterility - the official journal of the American Society for Reproductive Medicine.

24 Feb 2011

Efficacy News and Research

Despite FDA action, Deston still believes Auralgan as a safe and effective drug product

First patient treated in KUR-023 pilot clinical trial to assess safety and efficacy of product candidate

FDA approves GSK's PROMACTA to treat rare blood disorder

Phase III trial results: Erlotinib has comparable efficacy to chemotherapy with better tolerability against lung cancer

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Avastin debate spills over until June FDA hearing

Well-being in adolescence linked to life satisfaction in adulthood

Medwell commits $2,000,000 investment in Mimetogen

Enrollment commences in NORDIC implantable cardioverter defibrillator clinical trial

Enobia completes patient enrollment in ENB-0040 Phase II study for HPP

MHI begins patient enrollment for new device to treat refractory angina

HRS invites NewCardio to present CardioBip system clinical study results at Annual Scientific Meeting

BioCryst receives HHS contract to complete peramivir Phase 3 study in patients with influenza

Feasibility study to test scalp cooling device in breast cancer patients undergoing chemotherapy

Study: More effective therapies needed for diabetes patients with ESRD

PolyMedix completes PMX-30063 Phase 1 exposure-escalation clinical study to treat Staph infections

BioSante completes patient enrollment in LibiGel Phase III trial for treatment of FSD

Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment

Positive results from Vertex VX-770 Phase 3 STRIVE study in patients with CF

G-CSF treatment improves inadequate endometrium during IVF cycles

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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