US FDA approves IMRIS’ next generation VISIUS Surgical Theatre

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VISIUS Surgical Theatre

IMRIS Inc., a global leader in providing image guided therapy solutions, has received the US Food and Drug Administration clearance for newest generation VISIUS Surgical Theatre which integrates Siemens’ latest high-field MR scanners. The new core imaging technology based on Siemens Aera 1.5T(tesla) and Skyra 3.0T technology helps IMRIS deliver better image quality with higher signal-to-noise ratio, faster 3D image acquisition, and improved ease-of-use and workflow during neurosurgical procedures using intraoperative MRI (iMRI).

“These high-field intraoperative scanner options will give a hospital’s clinical team imaging applications and image quality that increase productivity,” said IMRIS president and CEO Jay D Miller. “We are bringing the latest and unequaled imaging technology into the operating room where it can make the most difference – during the surgery. IMRIS systems have been used in over 13,000 cases worldwide to improve outcomes in brain tumor and epilepsy surgeries in particular.”

The addition of these MR systems expands the industry-leading 1.5T and 3.0T MRI choices hospitals have when considering the unique, ceiling-mounted IMRIS solution for intraoperative imaging which brings the MRI to the patient during the procedure.

The first installation of this new generation VISIUS Surgical Theatre will be a four-room hybrid operating room suite, known as the Centre for Surgical Innovation (CSI) at Dartmouth-Hitchcock Medical Centre in Lebanon, Nebraska. “Surgeons are too often limited by what they cannot see –anatomy that is difficult to reach or diseases that are not visible to the naked eye,” says Sohail Mirza MD, medical director of CSI and chair of orthopedics at Dartmouth-Hitchcock. “The advanced integration of state-of-the-art imaging tools in CSI will allow surgeons and engineers to innovate like never before, rapidly developing, testing, and validating new surgical tools and techniques, with the goal of achieving better, safer, and, in some cases, less-costly care for patients everywhere.”

The Dartmouth-Hitchcock installation will also include a VISIUS intraoperative CT (iCT), which utilizes the technology of the 64-slice Siemens SOMATOM Definition AS scanner, making it the only operating suite in the world with both VISIUS iMRI and iCT modalities able to serve multiple operating rooms (ORs) without moving the patient.

Inside a VISIUS Surgical Theatre equipped with either high-field iMRI or iCT, surgeons have ondemand access to real-time data and state-of-the-art imaging, during the procedure from the OR table. The Company also designs and manufactures proprietary head fixation devices, imaging coils, and OR tables for use in this unique and multifunctional intraoperative environment.

IMRIS is a global leader in providing image guided therapy solutions through its VISIUS Surgical Theatre – a revolutionary, multifunctional surgical environment that provides unmatched intraoperative vision to clinicians to assist in decision making and enhance precision in treatment.

Source: PharmaBiz


Health Canada approves Abilify Maintena to treat schizophrenia.

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Otsuka Pharmaceutical Co., Ltd. and H Lundbeck has received the Notice of Compliance from the Health Canada for Abilify Maintena, an intramuscular (IM) once-monthly injectable formulation indicated for the maintenance treatment of schizophrenia in stabilized adult patients. Abilify Maintena will be the first commercialized product in Canada from the global alliance between Otsuka and Lundbeck, which is focused on developing Central Nervous System (CNS) therapies worldwide.

The companies expect the product will be available in Canada in April 2014.

Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia. In controlled clinical trials, Abilify Maintena was shown to be significantly superior in comparison to non-active treatments (placebo or pseudo-placebo) in the prevention of psychotic symptoms/impending relapse for up to 38 weeks after stabilization with oral aripiprazole. Further, efficacy was found to be comparable to that of oral aripiprazole with a similar tolerability profile. Efficacy was demonstrated through two pivotal trials: a 38-week, active-controlled trial to examine the proportion of subjects meeting impending relapse criteria and a 52-week, placebo-controlled trial, which examined the time to impending relapse. In the latter study, time to impending relapse was significantly delayed with Abilify Maintena compared with IM placebo (p < 0.0001; log rank test).

Otsuka and Lundbeck established a global alliance in November 2011 to bring to bear their considerable experience and resources in the CNS area to introduce next-generation treatments for conditions such as schizophrenia, depression, Alzheimer’s disease and alcohol dependency.

OCPI, a part of the Otsuka Group, is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada, with a focus on commitment to neuroscience, cardiovascular, and oncology. OCPI is dedicated to improving patients’ health and the quality of human life.

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases.

Source: PharmaBiz

FDA approves Vimizim to treat rare congenital enzyme disorder

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The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States.

Vimizim was granted priority review. An FDA priority review provides for an expedited review of drugs for serious diseases or conditions that may offer major advances in treatment. Vimizim is also the first drug to receive the Rare Pediatric Disease Priority Review Voucher – a provision that aims to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

“This approval and rare pediatric disease priority review voucher underscores the agency’s commitment to making treatments available to patients with rare diseases,” said Andrew E. Mulberg, M.D., deputy director, Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research (CDER). “Prior to today’s approval, patients with this rare disease have had no approved drug treatment options.”

The safety and effectiveness of Vimizim were established in a clinical trial involving 176 participants with Morquio A syndrome, ranging in age from 5 to 57 years. Participants treated with Vimizim showed greater improvement in a 6-minute walk test than participants treated with placebo. On average, patients treated with Vimizim in the trial walked 22.5 meters farther in 6 minutes compared to the patients who received placebo.

The most common side effects in patients treated with Vimizim during clinical trials included fever, vomiting, headache, nausea, abdominal pain, chills and fatigue. The safety and effectiveness of Vimizim have not been established in pediatric patients less than 5 years of age. Vimizim is being approved with a boxed warning to include the risk of anaphylaxis. During clinical trials, life-threatening anaphylactic reactions occurred in some patients during Vimizim infusions.

Vimizim is marketed by Novato, Calif.-based BioMarin Pharmaceutical Inc.

Source : USFDA

FDA approves clinical trial wearables

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US regulators have approved two new wristwatch-like devices for use in clinical trials.

Cambridge, UK-based firm CamNtech’s MotionWatch and Pro-Diary medical devices both use ‘accelerometer’ motion sensors to document physical movement.

The Pro-Diary (pictured) also has a built-in score pad to capture patient reported outcomes and which can be used instead of, or in addition to, traditional written patient diary in conjunction with activity monitoring.

They join CamNtech’s existing Actilheart and Actiwave devices on the market and have been cleared by the FDA “to assess activity in any instance where quantifiable analysis of physical motion is desired”.

Such uses could include monitoring limb or body movements during daily living and sleep.

A number of wearable devices have hit the consumer market in the last year or so, including Fitbit and Nike’s FuelBand but, as MobiHealthNews notes, the only consumer device to win FDA approval so far has been the BodyMedia CORE Armband.


OvaScience’s Augment fertility treatment receives two US patents

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OvaScience, a life sciences company focused on the discovery, development and commercialization of female fertility treatments, has received two United States patents covering its Augment fertility treatment. Augment is based on the company’s egg precursor cell (EggPC) technology and is being developed to improve egg quality and the success of in vitro fertilization (IVF). Augment will be available in international IVF clinics this year.

“The new patents strengthen and extend the protection for Augment in support of our efforts to offer a potential new fertility treatment option to women and families,” said Michelle Dipp, chief executive officer of OvaScience. “We continue to aggressively pursue additional patents covering our EggPC technology and related fertility applications throughout the world.”

The issuance of these two patents builds upon the company’s Composition of Matter patent on EggPCs, and provides further protection for Augment through at least 2032. The newly issued patents broadly cover the Augment process, including: IVF by Augment; preparing an egg for use with assisted reproductive technologies (ART); and increasing the energy-generating capacity of an egg by Augment.

OvaScience plans to introduce Augment this year through an international programme called ‘ACE’ or Augment Centres of Excellence, which will enable physicians to gain experience using Augment and generate data. The company expects to establish ACE clinics in at least four international regions and record 40 to 60 Augment cycles in 2014. These IVF clinics in the ACE programme will transition to commercial centers by year end. As part Augment, mitochondria (or ‘energy’) from a woman’s EggPCs found in her ovaries are added to her mature egg at the time of fertilization during an IVF cycle.

Source: PharmaBiz