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Isis commences ISIS-FXIRx Phase 1 study for treatment of clotting disorders

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 1 study of ISIS-FXIRx, an antisense drug designed to treat clotting disorders. ISIS-FXIRx inhibits the production of Factor XI, a clotting factor that is an important component of the coagulation pathway. Because of its role in the intrinsic coagulation pathway, inhibition of Factor XI could offer an effective approach for preventing the formation of blood clots with a lower risk of bleeding.

2 Feb 2011

DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011

The Company announced that the University of Rochester in concert with ADEPT has selected the study results from the KRN5500 Phase 2 study to be presented at its March 25-26, 2011 conference. The presentation is entitled, "Management of Placebo Response in a Randomized Trial of KRN5500 in Patients with Neuropathic Pain and Cancer."

2 Feb 2011

Inovio publishes scientific paper detailing SynCon DNA vaccine preclinical study for prostate cancer

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of Inovio's SynCon DNA vaccine for prostate cancer targeting two antigens.

2 Feb 2011

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the status of the company's New Drug Application (NDA) for Morphine Sulfate Oral Solution as well as other pending product applications.

2 Feb 2011

Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes

Zealand Pharma A/S, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce that its partner, sanofi-aventis, today announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.

2 Feb 2011

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

2 Feb 2011

Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

Antares Pharma, Inc. today announced that the first patient has been dosed in a clinical study evaluating the VIBEX™ MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.

2 Feb 2011

BioMarin commences GALNS Phase 3 trial in patients with Morquio A Syndrome

BioMarin Pharmaceutical announced today that it has initiated a pivotal Phase 3 trial for N-acetylgalactosamine 6-sulfatase, intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA, also called Morquio A Syndrome.

1 Feb 2011

Positive interim results from H5N1 Avian Influenza VLP vaccine Phase II human clinical trial

Medicago, a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today reported positive interim results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate.

1 Feb 2011

Positive interim results from Medicago's Phase II clinical trial of H5N1 Avian Influenza VLP vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

1 Feb 2011

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

1 Feb 2011

Discovery Labs provides expanded update on efforts to gain FDA marketing authorization for Surfaxin in RDS

Discovery Laboratories, Inc. is providing an expanded update regarding ongoing efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization for Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants.

1 Feb 2011

AVEO commences enrollment in tivozanib Phase 2 study in renal cell carcinoma

AVEO Pharmaceuticals, Inc. today announced that it has initiated patient enrollment in a multi-center Phase 2 exploratory biomarker study of tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in patients with renal cell carcinoma (RCC).

1 Feb 2011

Circassia Phase II clinical trial confirms safety profile of ToleroMune cat allergy treatment

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the company's ToleroMune(R) cat allergy treatment significantly reduced patients' symptoms in a recently completed, large-scale phase II clinical trial. The study also confirmed the treatment's highly favourable safety profile.

1 Feb 2011

Highly favorable final results from ERGOFLEX initial clinical study for joint pain relief

OXIS International, today announced highly favorable final results from an initial clinical study to assess the beneficial effects of its patent-pending ERGOFLEX joint health formula, launched commercially in December 2010.

1 Feb 2011

Positive results from NRM8499 phase I clinical study in patients with Alzheimer's disease

BELLUS Health announced today the results of the phase I clinical study for NRM8499, a prodrug of tramiprosate, intended for the treatment of Alzheimer's disease.

1 Feb 2011

$FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma$

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma.

1 Feb 2011

VBL commences two studies to evaluate efficacy, safety of VB-111 in advanced cancers

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced the initiation of two studies to further evaluate the efficacy and safety of VB-111 in advanced cancers.

31 Jan 2011

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

Maxygen, a biotechnology company focused on the development of improved protein drugs, today announced the initiation of a Phase I clinical study to evaluate a next-generation CTLA4-Ig therapeutic that is being developed by Perseid Therapeutics LLC, Maxygen's majority-owned subsidiary, in collaboration with Astellas Pharma Inc. for the treatment of rheumatoid arthritis and potentially other autoimmune indications.

31 Jan 2011

GATTEX Phase 3 pivotal study reaches primary efficacy endpoint of reducing PN in patients with SBS

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced that its Phase 3 pivotal study of GATTEX met the primary efficacy endpoint of reducing parenteral nutrition dependence in patients with adult short bowel syndrome.

31 Jan 2011

Drug Trial News

Isis commences ISIS-FXIRx Phase 1 study for treatment of clotting disorders

DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011

Inovio publishes scientific paper detailing SynCon DNA vaccine preclinical study for prostate cancer

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

BioMarin commences GALNS Phase 3 trial in patients with Morquio A Syndrome

Positive interim results from H5N1 Avian Influenza VLP vaccine Phase II human clinical trial

Positive interim results from Medicago's Phase II clinical trial of H5N1 Avian Influenza VLP vaccine

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

Discovery Labs provides expanded update on efforts to gain FDA marketing authorization for Surfaxin in RDS

AVEO commences enrollment in tivozanib Phase 2 study in renal cell carcinoma

Circassia Phase II clinical trial confirms safety profile of ToleroMune cat allergy treatment

Highly favorable final results from ERGOFLEX initial clinical study for joint pain relief

Positive results from NRM8499 phase I clinical study in patients with Alzheimer's disease

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

VBL commences two studies to evaluate efficacy, safety of VB-111 in advanced cancers

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

GATTEX Phase 3 pivotal study reaches primary efficacy endpoint of reducing PN in patients with SBS

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