Merck Serono has launched its easypod Connect, which monitors injection data collected by the easypod auto-injector in patients receiving growth hormones, in Europe.

The medical software is designed to display patients’ injection history from the easypod electronic auto-injector on a secured online database.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “easypod Connect is a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient.”

easypod Connect provides healthcare professionals with reports and data from the patient’s injection history, which both monitors and analyses patients treatment adherence.

The easypod Connect Observational Study (ECOS) has already been in use since its launch at the end of 2010, offering the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data.

Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono, said: “By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes.”

easypod Connect has already been launched in Canada and Australia. The medical device has not been submitted for use in the US.

With financial experts warning of another global recession it’s a worrying time for both healthcare professionals and those currently without a job.

The Government in its ultimate wisdom last week revealed plans to eliminate certain discrimination laws in an attempt to make it easier for employers to do away with unproductive workers and replace those with a willingness to work.

But while the principle may sound simplistic, one boss’ judge of a productive medical representative doing their upmost to sell a dated product may be different to the person struggling to succeed in a crowded and competitive marketplace.

Instead of casting aside one unproductive worker for another, the Chartered Institute of Personnel and Development (CIPD) has called for the Government to scrap its intention to remove certain discrimination laws and instead focus on those with healthcare jobs, for example, to increase their skill set to improve productivity.

The CIPD’s calls aren’t exactly rocket science – yet they do make sense. Questions have to be raised why so many employees are unhappy with the level of productivity of their workforce. The reason may be closer to home.

More than a third of the workforce in the UK has managerial responsibilities. But how many of those dedicate time to improving the skill sets of their staff? Whilst training days or programmes may not provide immediate results the long term skills gain can yield rewards for years to come.

The key to unlocking productivity levels may not be with those set for the axe, but those wielding it in the first place.

An eye-surgery robot designed to help surgeons with precision and ease during operations has been developed at Eindhoven University.

The system filters out hand tremors, which tend to occur more often with increased age.

Researcher Thijs Meenink said: “When ophthalmologists start operating they are usually already at an advanced stage in their careers. But at a later age it becomes increasingly difficult to perform these intricate procedures.”

The medical device allows the ophthalmologist to be in complete control, operating from the ‘master’ using two joysticks. Two robotic arms (the ‘slave’ developed by Meenink) then copy the master’s movements.

The surgeon’s movements are scaled down, so that each centimetre of joystick motion translates to only one millimetre of movement by the instrument “increasing the precision of the movements”, as Meenink commented.

Ophthalmologist Professor Marc de Smet, one of Meenink's PhD supervisors, said: “Robotic eye surgery is the next step in the evolution of microsurgery in ophthalmology, and will lead to the development of new and more precise procedures.”

Meenink has also designed an ‘instrument changer’, so that the robot can use different instruments during surgery. This reduces procedure time, as some eye operations can require as many as 40 instrument changes.

The first human operation using the new technology is expected within the next five years.

Novo Nordisk has increased operating profits by 12% in the first nine months of the year after sales growth rose due to the performance of Victoza (pictured), NovoRapid and Levemir.

Sales of modern insulins increased by 11% after Victoza sales nearly DKK 3.9 billion which resulted in net profit jumping nearly a fifth (19%) to DDK 12.4 billion.

Lars Rebien Sørensen, President and CEO, says Novo is “pleased” to see its key products “drive strong underlying sales growth”.

The Danish-based company has now updated its outlook for the year and expect sales growth to be between 10%-11% and operating profits growth be in the region of 17%-19%.

In North America sales increased by 17% and in other International Operations by 16%. Gross margin improved by 0.2% which Novo says reflects a favourable product mix development due to an increase in sales of modern insulin versus lower human insulin sales.

Regulatory dossiers for the company’s new generation of insulins, Degludec and DegludecPlus, were also submitted to the European and US authorities in September. “The filing of our new-generation insulins, ultra-long-acting Degludec and DegludecPlus, in the US and Europe is a major milestone in the expansion of our leadership in diabetes care."

Novo has now adjusted its preliminary outlook for next year which indicates a high single-digit sales growth and an operating profit increase near 10%.

The company increased its operating profit by nearly a third in 2010.

Nephron Pharmaceuticals plans to build a $313 million plant in Cayce, South Carolina, creating 707 new pharmaceutical jobs.

The generic respiratory treatment specialist will build its new facility on a 60-acre site to help expand its market and develop a pipeline of products.

Nephron currently employs more than 400 people at its manufacturing and distribution facility in Orlando, Florida.

The state will contribute $4.5 million to the facility’s preparation and construction costs, which is set to be up and running within the next couple of years.

The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).

Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.

The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.

He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.

DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.

Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.

Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

The growth of products including Plavix, Sprycel, Yervoy helped Bristol-Myers Squibb record a net sales increase of 11% to $5.3 billion in the third quarter of 2011.

Net sales in the US were up 11% to $3.5 billion and international sales increased by 12% to £1.9 billion which saw GAAP Diluted EPS and Non-GAAP Diluted EPS both up.

Lamberto Andreotti, CEO, BMS, says the “solid financial results” demonstrate the company’s ability to “execute our short-term plans while at the same time laying a solid foundation for our future”.

Product sales growth was led by Plavix which grew 8% and Abilify which recorded a 14% increase in sales in Q3. Onglyza and the recently launched Kombiglyze combined to deliver revenue of $127 million in the quarter, Yervoy raised $121 million with BARACLUDE (+36%), Sprycel (+47%), Orencia (+27%) all generating increased sales.

As a result, gross margin as a percentage of net sales was up slightly to 73.7% compared to Q3 2010, although expenses in marketing, selling, administration, advertising, product promotion and R&D all increased.

BMS’ results were boosted by important new data from its pipeline, including analysis on Eliquis for stroke prevention in patients with atrial fibrillation which, when compared to warfarin, reduced the risk of stroke or systemic embolism by 21%, the risk of major bleeding by 31% and the risk of mortality by 11%.

“I am quite pleased with the Company’s diverse achievements,” said Lamberto Andreotti. “We had strong sales and earnings growth in the quarter. We are excited by the strength of the Phase III data presented on ELIQUIS for stroke prevention in patients with atrial fibrillation and by the possibility that ELIQUIS could play a key role in the Company’s future.

The EC has approved Eli Lilly’s Alimta (pemetrexed for injection) as continuation maintenance therapy in patients with nonsquamous non-small cell lung cancer (NSCLC).

Alimta is the first chemotherapy to be approved in Europe for continuation maintenance therapy, for NSCLC patients who have shown a positive response or disease stabilisation following treatment with first-line Alimta plus cisplatin.

Allen Melemed, Senior Medical Director at Lilly Oncology, said: “Tailored therapies have come to the forefront of cancer treatment because they allow clinicians to select the right treatment for the right patient.”

The European approval was based on results from PARAMOUNT, a randomised double-blind Phase III study of 939 patients with advanced nonsquamous NSCLC.

The study showed that Alimta continuation maintenance therapy improved progression-free survival, as well as overall survival, after Alimta-cisplatin first-line therapy.

Alimta is approved in Europe and the US for three indications in patients with advanced nonsquamous NSCLC, including first-line treatment in combination with cisplatin, second-line treatment, and maintenance treatment of patients whose disease has not progressed immediately following platinum-based chemotherapy.

The drug is also approved for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma in the EU and US.

Lung cancer is the most common form of cancer in the world, causing 1.3 million cancer deaths every year. Approximately 85-90% of all lung cancers are NSCLC.

Alimta was recommended by CHMP as continuation maintenance therapy for patients with advanced nonsquamous NSCLC in September 2011 and by NICE for use by the NHS in September 2009.

A neurostimulation device that offers sufferers from obstructive sleep apnoea (OSA) an alternative to continuous positive airway pressure (CPAP) therapy has gained CE Mark approval.

The Hypoglossal Nerve Stimulation (HGNS) system from US company Apnex Medical has been approved for sale in Europe based on the results of clinical studies in the US and Australia that showed the device to reduce the symptoms of OSA.

OSA – an inability to breathe during sleep – is estimated to affect 100 million people worldwide. It causes excessive daytime fatigue and increases the risk of stroke, heart disease and death.

CPAP therapy is the current standard for OSA, but many patients cannot tolerate it or comply poorly with it. The HGNS system offers a radically different approach: an implantable therapy that activates the muscles in the upper airway.

Implanted in the shoulder, the HGNS system measures the patient’s breathing during sleep and delivers mild electrical pulses to the hypoglossal nerve (which controls the tongue) to keep the airway open.

The system can be programmed to operate only when the patient is asleep, or be turned on and off with a hand-held switch.

The Apnex Clinical Study, a randomised clinical trial, is ongoing in the USA, Europe and Australia. It is designed to test the safety and effectiveness of the HGNS therapy in patients with OSA in whom CPAP therapy has not been effective.

“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnoea and is a key milestone for our company,” said Chas McKhann, President and CEO of Apnex Medical. “We are excited to bring this innovative new therapy to Europe.”

Based in Minnesota, USA, Apnex Medical specialises in innovative therapies for sleep-disordered breathing.