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Halozyme Therapeutics announces Phase 1 clinical study to assess three insulin analogs

Halozyme Therapeutics, Inc. today announced the commencement of a Phase 1 clinical study that will assess the effects of three approved prandial (mealtime) insulin analogs administered with its proprietary rHuPH20 (PH20) hyaluronidase enzyme compared to each of the analogs alone. This randomized, three-way cross-over design, euglycemic clamp study will compare the postprandial pharmacokinetics (PK) and glucodynamics (GD) of the insulin analogs.

28 Sep 2009

European Commission grants conditional marketing authorization for Gilead's Cayston

Gilead Sciences, Inc. announced today that the European Commission has granted conditional marketing authorization for Cayston® 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF) aged 18 years and older.

28 Sep 2009

Preliminary results from procedural review of Menaflex released by the FDA

The U.S. Food and Drug Administration (FDA) yesterday released preliminary results of a review of its internal procedures surrounding the review of ReGen Biologics’Menaflex collagen meniscus implant for use in the U.S.

28 Sep 2009

Phase 2 clinical trial results of IMO-2055 announced

Idera Pharmaceuticals, Inc., today announced the presentation of final data from a clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as monotherapy in patients with Renal Cell Carcinoma (RCC). The data are being presented during the Eighth International Kidney Cancer Symposium being held in Chicago, September 25-26, 2009.

28 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Morphotek announces preliminary data from Phase II trial of farletuzumab

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

26 Sep 2009

HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.

25 Sep 2009

Careful follow-up after eradication therapy for peptic ulcer needed

Although it has been demonstrated that Helicobacter pylori causes gastric cancer, it is still controversial that whether H. pylori eradication therapy is effective in primary prevention of gastric cancer. This is especially important for Yamagata Prefecture, a region of Japan with the second highest incidence of gastric cancer in the world.

25 Sep 2009

RXi Pharmaceuticals acquires self-delivering rxRNA technology platform from Advirna

RXi Pharmaceuticals Corporation, a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that it has recently acquired direct ownership of technology for which it had previously exercised its option to exclusively license from Advirna LLC.

25 Sep 2009

NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

Altor BioScience Corporation announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II Bridge Grant by the National Cancer Institute (NCI). The award of $3 MM over three years will help Altor further its clinical development of ALT-801, a novel tumor-targeted immunotherapeutic designed to improve the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).

25 Sep 2009

US Treasury Department clears YM BioSciences' nimotuzumab clinical program extension

YM BioSciences Inc. a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for its fiscal year end, ended June 30, 2009.

25 Sep 2009

Phase III PLATO study proves that ticagrelor is more effective than clopidogrel

New data from the phase III PLATO study showed that ticagrelor (BRILINTA((TM))) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%,>

25 Sep 2009

Non-accredited education programs for people with chronic disabilities

iMedicor (VMCI.OB) formerly Vemics, Inc. and EP Global Communications (EPGL.OB) have announced the renewal of their strategic alliance agreement to produce Continuing Medical Education (CME) and non-accredited education programs for people with special needs and life long chronic disabilities. iMedicor/Vemics and EP Global Communications have worked together for a number of years and this relationship has generated substantial revenue for both companies and has provided a valuable service to the community they serve.

25 Sep 2009

The Adiana permanent contraception system supported by UK's NICE

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the United Kingdom's National Institute for Health and Clinical Excellence (NICE), in its updated guidance for hysteroscopic sterilization, supports the use of Hologic's Adiana((R)) permanent contraception system.

25 Sep 2009

Phase III clinical trial of investigational HIV vaccine regimen complete

Global Solutions for Infectious Diseases (“GSID”) announced today that a Phase III clinical trial of an investigational HIV vaccine regimen has been shown to be safe and modestly effective in preventing HIV infection. The double-blind, placebo controlled study was conducted in Thailand among more than 16,000 volunteers.

25 Sep 2009

NDA submitted to the FDA for new osteoarthritis drug

NicOx S.A. today announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (FDA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in Q4 2009.

25 Sep 2009

Partial success reported in the Phase 3 trial of HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), was pleased to hear the announcement today of partial success in the recently completed Phase 3 trial in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases.

25 Sep 2009

FDA grants priority review for Cephalon's sNDA

Cephalon, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year.

25 Sep 2009

Experimental HIV vaccine shows promise

An experimental HIV vaccine raises hope of reducing the risk of infection. Wall Street Journal/Associated Press reports: "For the first time, an experimental vaccine has prevented infection with the AIDS virus, a watershed event in the deadly epidemic and a surprising result. Recent failures led many scientists to think such a vaccine might never be possible."

25 Sep 2009

Interim results of a pilot study using BACE cardiac device released

Mardil, Inc. today announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device - BACE (Basal Annuloplasty of the Cardia Externally) -- in treating mitral valve regurgitation. The condition arises when the heart's mitral valve leaks blood backward into the heart, causing a range of severe and debilitating symptoms.

25 Sep 2009