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United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

United Therapeutics Corporation announced today the completion of its FREEDOM-C(2) 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.

24 Aug 2011

Avastin increases tumor response rates in breast cancer patients before surgery

Amid the controversy surrounding the Food and Drug Administration's ruling that Avastin should no longer be used to treat metastatic breast cancer, a new multinational Phase III clinical trial shows that Avastin significantly increased tumor response rates in breast cancer patients when given before surgery.

24 Aug 2011

Celldex announces key in vivo efficacy results of CDX-1135 in Dense Deposit Disease

Celldex Therapeutics, Inc. today announced key in vivo efficacy data for its CDX-1135 program from a collaboration with Drs. Richard Smith and Carla Nester at the University of Iowa.

24 Aug 2011

Seattle Genetics initiates ADCETRIS phase II trial in CD30-positive non-Hodgkin lymphoma

Seattle Genetics, Inc. today announced that it has initiated a phase II clinical trial of ADCETRIS for patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes.

24 Aug 2011

Helsinn begins enrollment in anamorelin Phase III trial for NSCLC-associated anorexia/cachexia

Helsinn, a Swiss-based pharmaceutical company, announced today that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer.

23 Aug 2011

Pearl selects TransPerfect's Trial Interactive eTMF solution for clinical development programs

TransPerfect today announced that Pearl Therapeutics has implemented TransPerfect's Trial Interactive electronic Trial Master File (eTMF) solution for the company's clinical development programs.

23 Aug 2011

Spinifex secures AU$6.25 million in expanded Series B funding

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

23 Aug 2011

Symphogen initiates Sym004 Phase 2 trial in squamous cell carcinoma of head and neck cancer

Symphogen A/S today announced the initiation of a Phase 2 clinical trial to investigate the safety and efficacy of Sym004 in patients who have failed anti-EGFR monoclonal antibody (mAb)-based therapy, with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

23 Aug 2011

Living Cell Technologies xenoimplants first patients in Argentina trial

Living Cell Technologies Limited has implanted the first two patients taking part in a Phase II DIABECELL® clinical trial in Buenos Aires, Argentina.

22 Aug 2011

Researchers turn their attention to Chagas disease as developed countries see rise in infection rates

Chagas disease, a historically neglected tropical disease that the WHO estimates affects about 10 million people worldwide, is drawing increased attention as infection by the parasite spreads from Latin America to developed countries, such as Spain and the United States, Science reports.

20 Aug 2011

VOA News examines ethics of clinical drug testing in African nations

VOA News examines the ethics of conducting clinical drug trials in developing countries, particularly in Africa. Several international ethical frameworks outline guidelines for clinical trials, "including the World Medical Association's Declaration of Helsinki and the WHO's Good Clinical Practice Guidelines," but they are not mandatory, the news service writes.

19 Aug 2011

Time-release corticosteroid implant effective in treating uveitis

A team of researchers comparing the two leading treatment approaches for the eye condition uveitis, which is the fifth leading cause of blindness in the US, have found that a time-release corticosteroid implant placed surgically in the eye is similarly effective in treating the disease as anti-inflammatory corticosteroids and immunosuppressive drugs taken orally. The report was published online this week in the journal Ophthalmology.

19 Aug 2011

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen today announced that it will present data from several Prolia (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

19 Aug 2011

NIH/NINDS awards AMRI to develop pre-clinical drug candidate for spinal muscular atrophy

AMRI today announced it received a federal contract award from the National Institutes of Health (NIH)/National Institute of Neurological Disorders and Stroke (NINDS) to provide chemistry and other drug discovery technologies in support of NINDS' Medicinal Chemistry for Neurotherapeutics Program (MCNP), part of the NIH Blueprint Neurotherapeutics Network.

19 Aug 2011

Minocycline, EDTA may combat catheter-related bacterial infections in dialysis patients

Antibiotics can help ward off serious bacterial infections in kidney disease patients who use tubes called catheters for their dialysis treatments. But if antibiotics are used too often, "super bugs" may crop up that are resistant to the drugs.

19 Aug 2011

FDA grants Fast Track designation for DARA's KRN5500 neuropathic pain relief drug

DARA BioSciences, Inc. announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

19 Aug 2011

Antigen Express provides update on ongoing AE37 Phase 2 trial in breast cancer

Generex Biotechnology Corporation announced today that the Company's wholly-owned subsidiary Antigen Express, Inc. presented an update of the ongoing Phase 2 trial with an off-the-shelf immunotherapeutic cancer vaccine, AE37, in patients with breast cancer at Cambridge Healthtech Institute's Sixth Annual ImVacS: The Immunotherapeutics and Vaccine Summit held August 16-18, 2011 in Cambridge, MA.

19 Aug 2011

BTI completes SUGARDOWN human clinical study on blood sugar management

Boston Therapeutics, Inc. (BTI), a public company registered with the SEC and a developer of diabetes therapeutics, announced today the completion of a trial in healthy volunteers performed at the University of Sydney on SUGARDOWN, a dietary supplement designed to reduce post-meal elevation of blood glucose.

18 Aug 2011

New leukemia drug in early clinical testing offers some clues for better treatment

While testing a new drug designed to treat chronic leukemia, researchers at Cleveland Clinic discovered new markers that could identify which patients would receive maximum benefit from the treatment.

18 Aug 2011

FDA approves Mayo Clinic's ovarian and breast cancer vaccines

Mayo Clinic has received investigational new drug approval from the Food and Drug Administration for two new cancer vaccines that mobilize the body's defense mechanisms to destroy malignant cells.

18 Aug 2011

Drug Trial News

United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

Avastin increases tumor response rates in breast cancer patients before surgery

Celldex announces key in vivo efficacy results of CDX-1135 in Dense Deposit Disease

Seattle Genetics initiates ADCETRIS phase II trial in CD30-positive non-Hodgkin lymphoma

Helsinn begins enrollment in anamorelin Phase III trial for NSCLC-associated anorexia/cachexia

Pearl selects TransPerfect's Trial Interactive eTMF solution for clinical development programs

Spinifex secures AU$6.25 million in expanded Series B funding

Symphogen initiates Sym004 Phase 2 trial in squamous cell carcinoma of head and neck cancer

Living Cell Technologies xenoimplants first patients in Argentina trial

Researchers turn their attention to Chagas disease as developed countries see rise in infection rates

VOA News examines ethics of clinical drug testing in African nations

Time-release corticosteroid implant effective in treating uveitis

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

NIH/NINDS awards AMRI to develop pre-clinical drug candidate for spinal muscular atrophy

Minocycline, EDTA may combat catheter-related bacterial infections in dialysis patients

FDA grants Fast Track designation for DARA's KRN5500 neuropathic pain relief drug

Antigen Express provides update on ongoing AE37 Phase 2 trial in breast cancer

BTI completes SUGARDOWN human clinical study on blood sugar management

New leukemia drug in early clinical testing offers some clues for better treatment

FDA approves Mayo Clinic's ovarian and breast cancer vaccines

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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