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Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

7 Jun 2011

Ovarian cancer screenings do not reduce risk of death

A University of Alabama at Birmingham study released today reports that ovarian cancer screenings do not reduce a woman's risk of death from the disease and the invasive medical procedures may create associated health problems.

7 Jun 2011

EC approves Biogen Idec's AVONEX PEN to treat multiple sclerosis

Biogen Idec announced today that the European Commission (EC) has granted approval to AVONEX PEN for patients with relapsing multiple sclerosis (MS) and patients who have had a single demyelinating event.

7 Jun 2011

Crucell, GSK and PATH MVI partner to develop second-generation vaccine against malaria

The PATH Malaria Vaccine Initiative (MVI) announced today that it has entered into a collaboration with Dutch biopharmaceutical company Crucell N.V. and GlaxoSmithKline.

7 Jun 2011

Non-steroidal, oral contraceptive for men

Researchers at Columbia University Medical Center are honing in on the development of what may be the first non-steroidal, oral contraceptive for men. Tests of low doses of a compound that interferes with retinoic acid receptors (RARs), whose ligands are metabolites of dietary vitamin A, showed that it caused sterility in male mice.

7 Jun 2011

Tragara's apricoxib-erlotinib Phase 2 study data on non-small cell lung cancer presented at ASCO 2011

Tragara Pharmaceuticals, Inc. announced today that apricoxib in combination with erlotinib demonstrated significant and consistent clinical benefit over erlotinib alone in a clinically relevant subset of biomarker-selected patients with non-small cell lung cancer (NSCLC) who had previously failed a platinum-containing regimen for advanced disease.

7 Jun 2011

Symphogen's Sym004 Phase 1 trial data on advanced solid tumors presented at ASCO 2011

Symphogen announced today preliminary primary endpoint data on 12 of 20 patients enrolled in the first Phase 1 clinical trial with their lead cancer compound, Sym004.

7 Jun 2011

Teva's lipegfilgrastim-pegfilgrastim comparative Phase III study in breast cancer meets primary endpoint

Teva Pharmaceutical Industries Ltd. announced today that lipegfilgrastim achieved its primary endpoint of reducing the duration of severe neutropenia in a Phase III study designed to evaluate the efficacy and safety of lipegfilgrastim (XM22) compared to pegfilgrastim (Amgen's Neulasta™).

7 Jun 2011

Positive results from RXi NeuVax Phase 2 trial on breast cancer presented at ASCO 2011

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, announced updated data from its Phase 2 clinical trial of NeuVax at the American Society of Clinical Oncology (ASCO) annual meeting.

7 Jun 2011

PATH malaria vaccine initiative to collaborate with GSK and Crucell in development of 2nd-generation malaria vaccine

The PATH Malaria Vaccine Initiative (MVI) announced today that it has entered into a collaboration with Dutch biopharmaceutical company Crucell N.V. and GlaxoSmithKline (GSK). This collaboration is aimed at developing a second-generation vaccine against malaria—a deadly disease that kills close to 800,000 people annually, most of them young children under age five in Africa. MVI drives the development of malaria vaccines by joining its scientific, managerial, and field expertise with companies, universities, and governments to test potential malaria vaccines and invest in those with the most promise.

6 Jun 2011

Onconova to initiate ESTYBON Phase II/III study in pancreatic cancer

Onconova Therapeutics, Inc. announced two advances in the clinical development of ESTYBON (rigosertib, ON 01910.Na) in presentations at the annual meeting of the American Society of Clinical Oncology (ASCO), June 3-7, 2011, in Chicago, Illinois.

6 Jun 2011

Ganeden Biotech sells Sustenex and Digestive Advantage to Schiff for $40 million

Ganeden Biotech announced the sale of its leading Sustenex® and Digestive Advantage® brands of probiotic dietary supplements to Schiff Nutrition International, Inc. for $40 million in cash. Ganeden will also receive royalties on Schiff products containing GanedenBC30™.

6 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

Amylin's metreleptin clinical study data on partial lipodystrophy presented at ENDO 2011

Amylin Pharmaceuticals, Inc. today announced results from a study that showed treatment with metreleptin, an investigational treatment that is an analog of the human hormone leptin, improved diabetes and lipid control in patients with partial lipodystrophy.

6 Jun 2011

GTx to initiate two Ostarine Phase III trial for treatment of muscle wasting in patients with NSCLC

Following the conclusion of a series of meetings with the United States Food and Drug Administration (FDA), GTx, Inc. announced today the clinical trial design for the two Phase III Ostarine registration studies for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC).

6 Jun 2011

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

United Therapeutics Corporation announced today the completion of its FREEDOM-M Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension (PAH).

6 Jun 2011

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Sunovion Pharmaceuticals Inc. today announced that the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation has been accepted by the U.S. Food and Drug Administration.

6 Jun 2011

Positive interim results from CTI's OPAXIO-TMZ phase II trial on malignant brain tumors presented at ASCO

Cell Therapeutics, Inc. announced encouraging interim results of a phase II clinical study of OPAXIO combined with temozolomide and radiotherapy in patients with newly diagnosed high-grade malignant brain tumors.

6 Jun 2011

New data from Argos AGS-003, sunitinib Phase 2 combination study on RCC presented at ASCO

Argos Therapeutics today announced that new data from its Phase 2 combination study of its Arcelis immunotherapy for the treatment of renal cell carcinoma (RCC), AGS-003, in combination with sunitinib showed improvement over expectations for sunitinib alone in progression-free survival (PFS) in newly diagnosed metastatic RCC patients with unfavorable prognosis.

6 Jun 2011

ImmunoGen's IMGN901 Phase I trial data on multiple myeloma presented at ASCO 2011

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced positive clinical data with the Company's IMGN901 (lorvotuzumab mertansine) product candidate as featured in an oral presentation at the ASCO 2011 Annual Meeting in Chicago.

6 Jun 2011

Efficacy News and Research

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

Ovarian cancer screenings do not reduce risk of death

EC approves Biogen Idec's AVONEX PEN to treat multiple sclerosis

Crucell, GSK and PATH MVI partner to develop second-generation vaccine against malaria

Non-steroidal, oral contraceptive for men

Tragara's apricoxib-erlotinib Phase 2 study data on non-small cell lung cancer presented at ASCO 2011

Symphogen's Sym004 Phase 1 trial data on advanced solid tumors presented at ASCO 2011

Teva's lipegfilgrastim-pegfilgrastim comparative Phase III study in breast cancer meets primary endpoint

Positive results from RXi NeuVax Phase 2 trial on breast cancer presented at ASCO 2011

PATH malaria vaccine initiative to collaborate with GSK and Crucell in development of 2nd-generation malaria vaccine

Onconova to initiate ESTYBON Phase II/III study in pancreatic cancer

Ganeden Biotech sells Sustenex and Digestive Advantage to Schiff for $40 million

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

Amylin's metreleptin clinical study data on partial lipodystrophy presented at ENDO 2011

GTx to initiate two Ostarine Phase III trial for treatment of muscle wasting in patients with NSCLC

United Therapeutics completes oral treprostinil Phase 3 trial on pulmonary arterial hypertension

FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Positive interim results from CTI's OPAXIO-TMZ phase II trial on malignant brain tumors presented at ASCO

New data from Argos AGS-003, sunitinib Phase 2 combination study on RCC presented at ASCO

ImmunoGen's IMGN901 Phase I trial data on multiple myeloma presented at ASCO 2011

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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