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NIAID awards $6.25M to Profectus to optimize portfolio of genetic adjuvants

Profectus BioSciences, Inc., a technology based vaccine company devoted to the treatment and prevention of chronic viral diseases, today announced that it has received $6.25M in National Institute of Allergy and Infectious Disease (NIAID) grants and contracts.

8 Oct 2010

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Targacept, Inc. today announced top-line results from a Phase 2 clinical trial of AZD1446 conducted by AstraZeneca in adults with attention deficit/hyperactivity disorder (ADHD).

8 Oct 2010

Sucampo submits marketing application for Amitiza drug

Sucampo Pharmaceuticals, Inc. and Abbott today announced that Sucampo Pharma Ltd., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc., has submitted a marketing application to the Japanese Pharmaceuticals and Medical Devices Agency for approval to market Amitiza (lubiprostone) 24 mcg for the treatment of chronic idiopathic constipation (CIC).

7 Oct 2010

Privigen IVIg therapy effective for primary, secondary immunodeficiencies: Study

Privigen, the first and only 10% liquid intravenous immunoglobulin (IVIg) therapy stabilized with proline, is effective and well tolerated in patients with several primary and secondary immunodeficiencies, according to data presented today at the XIVth Meeting of the European Society for Immunodeficiencies. Results also demonstrate that Privigen offers significant protection against infection.

7 Oct 2010

Hizentra therapy effective for primary immunodeficiency patients

Hizentra (IgPro20) provides primary immunodeficiency (PI) patients with a safe and effective alternative to other immunoglobulin therapies when given in equivalent doses, according to Phase III pivotal trial data presented today at the XIVth Meeting of the European Society for Immunodeficiencies (ESID).

7 Oct 2010

Role of TGF-ß in cancer diseases

During this year's BIOTECHNICA exhibition, the international biotech news magazine „GEN - Genetic Engineering & Biotechnology News yesterday on 5 October 2010, held an information event with subsequent panel discussion featuring the topic TGF-ß an important target in cancer diseases.

7 Oct 2010

Top research papers on venous disease receive VDC Research Awards

The Venous Disease Coalition (VDC) presented the Coalition's second annual Research Awards to the top three research papers on venous disease published in 2009 at the organization's Seventh Annual Meeting in Alexandria, VA.

7 Oct 2010

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Ferring Pharmaceuticals Inc. today announced publication of one of its pivotal Phase 3 trials of LYSTEDA (tranexamic acid) tablets for cyclic heavy menstrual bleeding in the October issue of the peer-reviewed journal, Obstetrics & Gynecology. The six-month clinical trial demonstrated that LYSTEDA significantly reduced menstrual blood loss from baseline, and improved health-related quality-of-life parameters in women with cyclic HMB while maintaining safety and tolerability.

7 Oct 2010

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a pre-NDA assessment for Lymphoseek with the U.S. Food and Drug Administration (FDA).

7 Oct 2010

Pharmaxis receives FDA approval to market ARIDOL Test Kit

Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades.

7 Oct 2010

FDA unveils report to advance regulatory science

The U.S. Food and Drug Administration today unveiled a report outlining the agency's plans to advance regulatory science through its Regulatory Science Initiatie.

7 Oct 2010

'The Pittsburgh Protocol' enables reduction of multiple anti-rejection drugs after transplantation

The Pittsburgh Protocol is unique in utilizing bone marrow cells to enable reduction of the need for multiple anti-rejection drugs after transplantation. The University of Pittsburgh Medical Center is currently the only transplantation center in the world to offer it. An early report of the initial experience with the "Pittsburgh Protocol" in three recipients of upper extremity transplants was presented during the 2010 Annual Clinical Congress of the American College of Surgeons.

7 Oct 2010

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

A clinical trial designed to replace the genetic defect causing the most common form of muscular dystrophy has uncovered an unexpected aspect of the disease. The trial, based on therapy designed by scientists at the University of North Carolina at Chapel Hill School of Medicine, showed that some patients mount an immune response to the dystrophin protein even before they have received the gene therapy.

7 Oct 2010

Biogen to present late-stage clinical therapies for MS at ECTRIMS Congress

Biogen Idec today announced that more than 45 company and partner-sponsored platform and poster presentations will be presented during the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, October 13 - 16, 2010.

6 Oct 2010

Orthovita's Cortoss Bone Augmentation study results to be presented at NASS Annual Meeting

Orthovita, Inc.an orthobiologics and biosurgery company, is pleased to announce that Hyun W. Bae, M.D., of The Spine Institute at Saint John's Health Center in Santa Monica, California, will present an abstract entitled, Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial,at the 25th Annual Meeting of the North American Spine Society (NASS) being held October 5-9, 2010 at the Orange County Convention Center in Orlando, Florida.

6 Oct 2010

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

ISTA Pharmaceuticals, Inc., today announced positive preliminary results from a Phase 1/2 clinical study of bepotastine besilate nasal spray conducted in Canada for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.

6 Oct 2010

Focused Ultrasound Surgery Foundation hosts conference to discuss advancements in therapeutic medicine

The Focused Ultrasound Surgery Foundation is hosting the 2nd International Symposium on MR-guided Focused Ultrasound in Chantilly, Virginia from October 17-20. Leading researchers and clinicians from around the world will gather at the three-day scientific conference to present and discuss the latest advancements in one of the most revolutionary and promising areas of therapeutic medicine.

6 Oct 2010

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

ACR Image Metrix, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to announce a Phase III trial, conducted for Aegerion Pharmaceuticals, Inc., was published as an abstract in the online supplement of Atherosclerosis and presented at the 78th European Atherosclerosis Society Congress, which took place June 20-23, 2010, in Hamburg, Germany.

6 Oct 2010

Anticancer drug Cisplatin induces side effects

Cisplatin, an anticancer drug widely used for treating various types of tumor, can induce side effects in the short term. A team of scientists, mostly from CNRS and the Université de Nice has provided first in vitro evidence that this antitumor agent modifies the sensitivity of cellular pressure sensors. This completely novel mechanism could help to elucidate certain neurological side effects of cisplatin hitherto unexplained.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Efficacy News and Research

NIAID awards $6.25M to Profectus to optimize portfolio of genetic adjuvants

Targacept announces top-line results from AZD1446 Phase 2 clinical trial for ADHD

Sucampo submits marketing application for Amitiza drug

Privigen IVIg therapy effective for primary, secondary immunodeficiencies: Study

Hizentra therapy effective for primary immunodeficiency patients

Role of TGF-ß in cancer diseases

Top research papers on venous disease receive VDC Research Awards

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Neoprobe completes pre-NDA assessment for Lymphoseek with FDA

Pharmaxis receives FDA approval to market ARIDOL Test Kit

FDA unveils report to advance regulatory science

'The Pittsburgh Protocol' enables reduction of multiple anti-rejection drugs after transplantation

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

Biogen to present late-stage clinical therapies for MS at ECTRIMS Congress

Orthovita's Cortoss Bone Augmentation study results to be presented at NASS Annual Meeting

ISTA Pharmaceuticals announces Phase 1/2 clinical study results of bepotastine besilate nasal spray

Focused Ultrasound Surgery Foundation hosts conference to discuss advancements in therapeutic medicine

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

Anticancer drug Cisplatin induces side effects

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

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