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CTI to re-submit pixantrone NDA to FDA's Office of New Drugs for re-review

Cell Therapeutics, today announced that the Office of New Drugs of the U.S. Food and Drug Administration after carefully reviewing the materials CTI submitted in support of its appeal, the reviews of the New Drug Application for pixantrone prepared by the FDA staff, the transcript of the March 22, 2010 Oncology Drugs Advisory Committee meeting and consulting with the Center for Drug Evaluation and Research's Deputy Director of Clinical Science and the Office of Biostatistics, concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved.

3 May 2011

Desirudin more effective for VTE prevention in patients with renal impairment

Desirudin reduced major venous thromboembolism and post-operative bleeding compared with the standard of care, enoxaparin, in patients with poor kidney function undergoing orthopedic surgery, according to a poster presented at the Arteriosclerosis, Thrombosis and Vascular Biology meeting.

3 May 2011

MRI can effectively determine patients with endometrial and cervical cancers

MRI can determine if a patient has endometrial versus cervical cancer even when a biopsy can't make that distinction, according to a new study. Determining the primary site of a tumor helps determine appropriate cancer treatment.

3 May 2011

Tecnologie Avanzate, Naviscan sign deal to distribute PET scanner in Italy

Naviscan, Inc., the leader in 3D Molecular Breast Imaging, has entered into a distribution agreement with Tecnologie Avanzate s.r.l. to market and service Naviscan's high-resolution organ-specific PET scanner in Italy.

3 May 2011

More HIV infections linked to injection drug use in East Africa, report finds

FDA approves new targeted therapy to treat men with advanced prostate cancer

The Food and Drug Administration on Thursday approved abiraterone, a new targeted therapy in the class of androgen receptor blockers.

3 May 2011

Esperion reports positive results from ETC-1002 Phase 1 study in dyslipidemia

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced the results from a Phase 1 study and four preclinical studies for ETC-1002 at the Arteriosclerosis, Thrombosis and Vascular Biology 2011 Scientific Sessions in Chicago.

3 May 2011

Cyberonics initiates first implant of AspireSR product in epilepsy patients

Cyberonics, Inc., a global leader in epilepsy management, today announced the first implant of its AspireSR™ seizure response product on April 27, 2011.

3 May 2011

New non-invasive device can measure brain's precise temperature

Doctors have long sought a way to directly measure the brain's temperature without inserting a probe through the skull. Now researchers have developed a way to get the brain's precise temperature with a device the diameter of a poker-chip that rests on a patient's head, according to findings presented May 1 at the annual meeting of the Pediatric Academic Societies in Denver.

3 May 2011

AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

AstraZeneca announced today that the U.S. Food and Drug Administration has approved the use of NEXIUM I.V. for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease with erosive esophagitis when oral therapy is not possible or appropriate.

3 May 2011

Progressive Physical Therapy, Doctors Care inaugurate new center in Newberry

Doctors Care and Progressive Physical Therapy, affiliates of UCI Medical Affiliates, Inc., today announced the opening of their newest center at 1410 Wilson Road in Newberry, South Carolina.

3 May 2011

Hebei Aoxing Pharma receives Chinese patent for naloxone sublingual film

Aoxing Pharmaceutical, a specialty pharmaceutical company focusing on research, development, manufacturing and distribution of narcotic and pain-management products, announced that its operating subsidiary in China, Hebei Aoxing Pharmaceutical Group Company, has been granted a patent by the State Intellectual Property Office of The People's Republic of China for naloxone sublingual film.

3 May 2011

Pregnant women with H1N1 more likely to have low birth weight baby

In 2009, the United States was gripped by concern for a new winter threat: the H1N1 strain of influenza. According to research conducted through that winter, pregnant women were right to be concerned.

3 May 2011

Positive Ellex 2RT data demonstrates efficacy in treatment of early Age-Related Macular Degeneration

Ellex Medical Lasers Limited (ASX:ELX) today announced milestone clinical results for its breakthrough Retinal Regeneration Therapy (Ellex 2RT™) for the treatment of Early Age-Related Macular Degeneration (AMD).

2 May 2011

Scientists identify biochemical abnormality behind Machado-Joseph disease

Scientists in Portugal have identified a biochemical abnormality behind the potentially fatal neurodegenerative Machado-Joseph disease and using several models of the disease were able to reverse the problem in what can be a crucial step towards a cure for humans .

2 May 2011

Temsirolimus with chemotherapy may serve as promising therapy for mesothelioma

A drug commonly used to treat kidney cancer may increase the effectiveness of chemotherapy for mesothelioma, according to a study published in the May issue of the Journal of Thoracic Oncology.

2 May 2011

Sorin first quarter consolidated revenues increase 4.7% to €182.3 million

For the second quarter of 2011, Sorin Group expects revenues to grow 1 - 2% compared to the same period of 2010 and a net profit of approximately €14 - 16 million.

30 Apr 2011

Animal-assisted therapy reduces anxiety in patients undergoing MRI: Study

Patients who undergo MRI often suffer from elevated anxiety. Patient discomfort may cause poor image quality due to motion artifacts or early termination. Anxiolytic medications are currently used to reduce this anticipated anxiety , but animal-assisted therapy may be a non-invasive alternative treatment with fewer adverse effects, according to an exhibit being presented at the 2011 American Roentgen Ray Society's annual meeting.

30 Apr 2011

No proven advantages of PET for diagnostic accuracy of head and neck tumours: Research

The benefit and harm of positron emission tomography in patients with head and neck tumours, applied alone or in combination with computed tomography, cannot currently be reliably assessed.

30 Apr 2011

USHIFU announces results from clinical investigation of Sonablate HIFU to treat prostate cancer

USHIFU LLC, a world leader in minimally invasive high intensity focused ultrasound technologies and manufacturer of the Sonablate 500 (Sonablate) medical device, announces results from the first-ever prospective clinical investigation of HIFU with the Sonablate to focally treat prostate cancer, a modality in which only the confirmed cancerous regions within the gland are treated as opposed to the entire prostate. Results from the study appear in this month's Journal of Urology.

30 Apr 2011