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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

Everolimus-eluting stent efficient in treating native coronary artery lesions

Late-breaking data from SPIRIT IV, a large-scale multi-center study of nearly 4,000 patients in the U.S., shows that an everolimus-eluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxel-eluting stent, and showed that "low late loss" may be achieved with drug-eluting stents without sacrificing safety.

24 Sep 2009

NICE updates its guidance on hysteroscopic sterilization

Conceptus, Inc., developer of the Essure procedure, the first proven non-incisional permanent birth control method available, today announced that the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has updated its guidance on hysteroscopic sterilization to support the use of the Essure permanent birth control procedure.

24 Sep 2009

Clinical trial comparing Boston Scientific's coronary stent systems

Boston Scientific Corporation today welcomed one-year data from the SPIRIT IV clinical trial comparing the XIENCE V((R)) (PROMUS((R))) Everolimus-Eluting Coronary Stent System to the TAXUS((R)) Express2(TM) Paclitaxel-Eluting Coronary Stent System. The results support the benefits of paclitaxel-eluting stents in diabetic patients. The trial enrolled 3,690 patients, including 1,140 diabetics, the largest diabetic subset ever studied in a drug-eluting stent clinical trial.

24 Sep 2009

Octapharma AG submits Biological License Application for its octagam(R) 10% to FDA

Octapharma AG recently submitted its Biological License Application for octagam(R) 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration (FDA) with the goal of expanding the biopharmaceutical company's U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

24 Sep 2009

Clinical study results of Novolimus and Myolimum eluting coronary stent systems released

Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today positive results from three multicenter first-in-man studies of Novolimus and Myolimus eluting coronary stent systems with durable and bioabsorbable polymers. Findings were presented at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT 2009) scientific symposium.

24 Sep 2009

New version of Adis R&D Insight global pipeline database launched

Wolters Kluwer Pharma Solutions, Inc., a leading provider of market data and competitive intelligence to the pharmaceutical and biotech industries, today introduced a powerful, new version of its popular Adis R&D Insight global pipeline database.

24 Sep 2009

Phase III efficacy trial of two AIDS vaccine candidates shows promise

The International AIDS Vaccine Initiative (IAVI) greeted with excitement today’s announcement by the U.S. Military HIV Research Program and the Thai Ministry of Public Health that, according to an initial analysis, a prime-boost combination of two AIDS vaccine candidates has shown partial efficacy in a phase III efficacy trial in Thailand. The prime-boost combination appeared to be about 31% effective at preventing infection with HIV.

24 Sep 2009

COMPARE trial results demonstrate higher efficacy of XIENCE V stent system

Late-breaking data presented today from the COMPARE trial demonstrated that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System demonstrated significantly better outcomes in key safety and efficacy measures compared to the TAXUS(R) Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS).

24 Sep 2009

ThromboGenics completes enrollment for MIVI-TRUST clinical trial

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease.

24 Sep 2009

New method found for the treatment of pancreatic cancer

For the first time researchers have shown that by inhibiting the action of an enzyme called TAK-1, it is possible to make pancreatic cancer cells sensitive to chemotherapy, opening the way for the development of a new drug to treat the disease.

24 Sep 2009

It is possible to reduce the risk of HIV infection with a vaccine: AVAC

"Today marks an historic milestone in the search for an AIDS vaccine; we now have evidence that it is possible to reduce the risk of HIV infection with a vaccine," said AVAC executive director Mitchell Warren, reacting to the results of the first AIDS vaccine trial to ever show efficacy at preventing HIV. "It will take time and resources to fully analyze, understand and validate the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit."

24 Sep 2009

Study reveals that AIR Inhaled Insulin is inferior to SC insulin

The commercial failure of Exubera- (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR- inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. (www.liebertpub.com). The supplement is available free online at www.liebertpub.com/dia

24 Sep 2009

ImThera Medical completes THN system development

ImThera Medical, Inc. announced today that it has completed development of its Targeted Hypoglossal Neurostimulation (THN) system for Obstructive Sleep Apnea (OSA).

24 Sep 2009

Enrollment for pSivida's pilot FAVOR clinical study commences

pSivida Corp., a leading drug delivery company that has developed two of the only three products approved by the FDA for the long term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien in patients with macular edema secondary to retinal vein occlusion.

24 Sep 2009

ADAGIO clinical trial results demonstrating AZILECT's efficacy published

Results from the ADAGIO trial, published online today in The New England Journal of Medicine, demonstrated that Parkinson’s disease patients receiving AZILECT (rasagiline) 1mg/day at the start of the study (early-start group) experienced superior benefit over 18 months compared with those who started the exact same treatment nine months later (delayed-start group).

24 Sep 2009

SPIRIT IV trial data demonstrates superior efficacy of XIENCE V stent system

Late-breaking data from the SPIRIT IV trial demonstrated that Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS) at one year.

24 Sep 2009

Results of Phase III clinical trial of HIV vaccine released

A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC(R)( )HIV and AIDSVAX(R) B/E( )lowered the rate of HIV infection by 31.2% compared with placebo.

24 Sep 2009