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USAID award supports study of SILCS diaphragm plus tenofovir gel on HIV, HSV

USAID awarded CONRAD a five year project with a $2 million ceiling to focus on testing the safety and effectiveness of the SILCS diaphragm, the one-size-fits-most contraceptive barrier, combined with tenofovir gel -- the only topical product proven to prevent the acquisition of HIV and Herpes Simplex Virus.

14 Oct 2011

New dual drug combinations in development for various cancers

A rarely used—and as yet largely unproven—approach to drug development has emerged as a significant tool in the effort to create high-impact new cancer drugs.

14 Oct 2011

Merck announces results from ISENTRESS Phase III combination study on HIV-1

Merck, known as MSD outside the United States and Canada, today announced results of new exploratory pre-specified analyses from the ongoing STARTMRK Phase III study of its integrase inhibitor ISENTRESS (raltegravir) Tablets in combination therapy compared to efavirenz in combination therapy in previously untreated adult HIV-1-infected patients.

14 Oct 2011

Micromet receives FDA feedback on blinatumomab registration for R/R ALL

Micromet, Inc. today outlined a clinical development plan intended to support U.S. registration of its lead product candidate blinatumomab in patients with B-precursor relapsed/refractory (r/r) acute lymphoblastic leukemia.

14 Oct 2011

Positive data from Anadys' setrobuvir Phase IIb combination study on genotype 1 HCV

Anadys Pharmaceuticals, Inc. today released interim antiviral response and safety data from an ongoing Phase IIb study of setrobuvir in combination with pegylated interferon and ribavirin (P/R) in genotype 1 hepatitis C patients.

14 Oct 2011

JCO publishes Keryx's KRX-0401 Phase 1 / 2 combination study on advanced MM

Keryx Biopharmaceuticals, Inc. today announced that a manuscript entitled "Perifosine Plus Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated with Bortezomib: Results of a Multicenter Phase l/2 Trial" reporting Phase 1 / 2 combination activity of KRX-0401 (perifosine) in the treatment of advanced multiple myeloma (MM) patients, was selected for publication in the October 11, 2011 online edition of the Journal of Clinical Oncology.

14 Oct 2011

Baxter commences BAX 111 Phase III trial in von Willebrand disease

Baxter International Inc. today announced initiation of a Phase III clinical trial to evaluate the safety and effectiveness of BAX 111, Baxter's investigational recombinant von Willebrand factor (rVWF), for the treatment and prevention of bleeding episodes in patients with von Willebrand disease.

From Baxter International Inc. 14 Oct 2011

InnaVirVax announces Phase I/IIa clinical trial authorization for its VAC-3S HIV vaccine

InnaVirVax, a biopharmaceutical company dedicated to the development of therapeutic and diagnostic solutions in pathologies associated with immune dysregulation, declared today that it has obtained authorization from the French drug agency (AFSSAPS) to start a Phase I/IIa clinical study of its therapeutic vaccine VAC-3S for the treatment of HIV infections. This authorization intervenes only two years and half after the launching of InnaVirVax’s activities.

14 Oct 2011

Top-line results from POZEN's PA32540 Phase 3 trial on aspirin-associated gastric ulcers

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today top-line results from study 303, a Phase 3 trial designed to track the long-term safety of PA32540 in patients who are at risk for developing aspirin-associated gastric ulcers.

13 Oct 2011

Hydromorphone can be as effective as diacetylmorphine in treating heroin addiction

A clinical trial to test better treatment options for chronic heroin addiction is expected to begin in Vancouver at the end of this year. Led by researchers from Providence Health Care and the University of British Columbia, it's the only clinical trial of its kind in North America.

13 Oct 2011

EMA recommends 4SC's resminostat for orphan medicinal product designation to treat HL

4SC AG, a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the European Medicines Agency (EMA) has recommended 4SC's anti-cancer compound resminostat for designation as orphan medicinal product for the treatment of Hodgkin's Lymphoma (HL), a cancer of the lymphatic system.

13 Oct 2011

Intellikine commences INK1117 Phase I dose escalation study in cancer

Intellikine, Inc., a company focused on the discovery and development of innovative, small molecule drugs targeting the PI3K/mTOR pathway, announced today that the first patient has been treated in a Phase I dose escalation study of INK1117 in patients with advanced solid malignancies.

12 Oct 2011

Vitamin E supplements linked with increased risk of prostate cancer

Men who took 400 international units (I.U.) of vitamin E daily had more prostate cancers compared to men who took a placebo, according to an updated review of data from the Selenium and Vitamin E Cancer Prevention (SELECT) Trial.

12 Oct 2011

Daily vitamin E supplementation may increase risk of prostate cancer

In a trial that included about 35,000 men, those who were randomized to receive daily supplementation with vitamin E had a significantly increased risk of prostate cancer, according to a study in the October 12 issue of JAMA.

12 Oct 2011

FDA grants Advaxis pre-IND meeting for ADXS-HER2 cancer immunotherapy

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been granted a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration on November 22nd, 2011 to discuss the initial clinical development plan for ADXS-HER2, a construct for the treatment of HER2 expressing cancers.

12 Oct 2011

AFFiRiS receives MJFF grant for clinical study of AFFITOPE PD01

The Michael J. Fox Foundation (MJFF) today announced that it has awarded $1.5 million to AFFiRiS AG, a Vienna, Austria-based biotech company, for a clinical study of AFFITOPE PD01, a first-of-its-kind Parkinson's disease (PD) vaccine.

12 Oct 2011

Shield commences two ST10 Phase 3 studies in iron deficiency anaemia

Shield Therapeutics (Shield), the independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need, today announced that the first patients have been treated in the two Phase 3 clinical studies of ST10 for the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease.

12 Oct 2011

NIH awards United Therapeutics $45 million contract to develop potential oral treatment for viruses

The National Institutes of Health (NIH) has awarded United Therapeutics Corporation a contract for up to $45 million over five years "to help develop a potential oral treatment for viruses like influenza and the mosquito-borne tropical fever dengue," the Associated Press/Washington Post reports.

12 Oct 2011

Isis designates ISIS-AATRx candidate in collaboration with GSK

Isis Pharmaceuticals, Inc. announced today that it has designated the second development candidate, ISIS-AATRx, in its collaboration with GlaxoSmithKline

12 Oct 2011

Merrimack begins MM-121 Phase 2 combination trial in HER2-negative breast cancer

Merrimack Pharmaceuticals, Inc. announced today that the first patient has been dosed in a randomized Phase 2 clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, combined with paclitaxel in the neoadjuvant setting of HER2-negative breast cancer patients.

12 Oct 2011