London-based pharma company Dainippon Sumitomo Pharma Europe (DSP Europe) has changed its name to Sunovion Europe.

The new name reflects the development of DSP’s European subsidiary into a more active commercial organisation, shortly to launch a new schizophrenia drug.

Sunovion Europe will focus on products to treat mental health and neurological disorders – including the atypical antipsychotic lurasidone hydrochloride, which it plans to launch in Europe shortly.

The company will also develop and market specialised drugs for disease areas where there is unmet medical need.

Lurasidone hydrochloride, a generic drug, has been submitted to the European Medicines Agency (EMA) for treatment of schizophrenia by DSP’s European partner, Takeda.

Dr Mike Taylor, Managing Director of Sunovion Europe, said: “This represents a significant landmark in the evolution of our European business as we prepare to commercialise our first drug in the UK.

“At Sunovion Europe we focus on the development and introduction of innovative medicines that improve people’s health and well-being. We will continue to focus on psychiatry and neurology, and over time will grow the European business to include other areas.”

Dainippon Sumitomo Pharma (DSP) is a multi-billion dollar company based in Japan. It was formed by the merger in 2005 of Dainippon Pharmaceutical Co. and Sumitomo Pharmaceuticals Co.

With a growing product portfolio and pipeline, DSP aims to become a major supplier of innovative treatments in psychiatry, neurology and oncology.

Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

The FDA has approved Sapien transcatheter heart valve (THV), an artificial aortic heart valve that can be placed without open-heart surgery.

Edward Lifescience’s device is the first artificial copy of an aortic heart valve to replace valves that have been damaged by senile aortic valve stenosis without open-heart surgery.

Dr Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health, said that the artificial valve “is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement”.

The approval was based on a study of 365 patients who were not eligible for open-heart surgery, half of which received the Sapien valve, the rest were given an alternative therapy that did not require open-heart surgery.

The study showed that patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant.

However, Sapien patients were more likely to survive one year after surgery, with 69% alive compared with 50% of those who received an alternative treatment.

Patients with severe aortic valve stenosis would usually have to undergo open-heart surgery to replace the valve, but some patients are unable to do so.

According to the FDA, more than half of all patients will die within two years of the onset of senile aortic stenosis.

Senile aortic valve stenosis is a progressive disease that can affect elderly patients. The condition incurs an accumulation of calcium deposits on the aortic valve, causing the valve to become narrower.

US-based orthobiologics company ISTO Technologies has received CE Mark Approval to market its InQu product line, a bone graft substitute and extender, in the EU.

The product is designed for use in non-structural areas of bone, such as small voids from benign tumour excisions.

Dr Mitchell Seyedin, President and CEO of ISTO, said: “The product has proven to be an innovative and cost-effective bone grafting alternative for spinal fusion and other orthopaedic surgeries in the United States and we believe that distribution in Europe will augment our domestic revenue growth.”

InQu is a differentiated biomaterial scaffold of synthetic and biologic polymers used mainly in spinal fusion applications.

Dr Seyedin said that the approval will “offer a great alternative for patients in need of bone grafting”.

Based in Missouri, ISTO is an orthobiologics company that develops proprietary products for spinal therapies and sport medicine applications. The company’s products are intended for the repair and regeneration of damaged or injured cartilage and bone.

Siemens Hearing Instruments has released a number of innovative audiology devices aimed at improving workflow and reaching a wider range of care environments.

The company’s new audiometers and digital video otoscopes extend the choice available from one specialist point of contact, promising to simplify procurement, save clinical time and reduce costs.

New audiology devices now available from Siemens include:

• Otopod and Amplitude Audiometers – tiny, portable wireless audiometers suitable for use in the fitting room, home or bedside
• Kamplex PA5 Paediatric Audiometer – a free field audiometer for testing children’s hearing with one-handed operation
• a high-resolution USB Digital Video Otoscope, which links directly to a PC.

The new devices join Siemens’ existing range of audiology workflow solutions. A wider range of audiological accessories is also now available.

“Our single approach to providing a wide range of audiology workflow solutions gives audiologists more choice and specialist advice,” said Mark Laben, Product and Marketing Manager at Siemens Hearing Instruments.

“Healthcare departments and practices are facing increased pressures to invest wisely and redesign audiology workflow processes. By having workflow that integrates together, audiologists will have more time to spend with the patient on quality matters such as talking through fittings and answering concerns.”

Based in Crawley, West Sussex, Siemens Hearing Instruments provides digital hearing instruments and software, patient management systems and audiology equipment to the NHS and retail dispensers in the UK.