The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

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.

A new study of 350,000 mobile phone users has found no link between mobile use and incidence of brain cancer.

The Danish study, which follows months of argument over the possible risks of wireless communication devices, does not include people who use mobile phones in their work.

The National Radiological Protection Board (NRPB) in the UK has said the study “lacks statistical precision” and is not conclusive, though Cancer Research UK has noted that it provides “the strongest evidence yet” for the safety of mobile phones.

Mobile healthcare or mHealth is one of the fastest-growing areas of medical technology, and experts such as health consultant David Lee Scher have recognised its potential to enable ‘participatory medicine’.

Led by the Institute of Cancer Epidemiology in Denmark, the new study looked at 350,000 mobile phone users over 18 years. It found no increased incidence of gliomas and other brain cancers.

The researchers said their study could not rule out potential risks to children and to people whose work includes heavy mobile phone usage.

Hazel Nunn, Head of Evidence and Health Information at Cancer Research UK, said the Danish study provided “the strongest evidence yet that using a mobile phone does not seem to increase the risk of cancers of the brain in adults.”

However, the NRPB, which advises the government on radiation safety, said the study was not large enough to be conclusive.

Two specialists interviewed in a recent Panorama programme said their own studies indicated cause for concern. Dr Lennart Hardell (Sweden) reported finding a strong correlation between location of brain tumours and the side of the head used for mobile phone calls. Dr George Carlo (USA) said his study indicated an increased risk of a rare type of brain cancer.

Dr Carlo commented: “This is not black and white... we have moved now into a grey area that needs to be looked into very, very carefully.”

In May 2011, a Council of Europe committee declared mobile phone usage to be “potentially harmful” and called on governments to “take all reasonable measures” to reduce their use, particularly in schools.

Shortly afterwards, the World Health Organisation included mobile phones in the same “possibly carcinogenic” category as lead and car exhaust fumes, and called for further research. The Danish study is a major step in that process.

Thermo Fisher Scientific, a leading global supplier of products to support medical and other life sciences, has acquired Phadia, a leading specialist supplier of blood tests to diagnose and monitor allergies and autoimmune diseases.

Phadia, which has 1,500 employees worldwide, will become part of Thermo Fisher’s Specialty Diagnostics business.

The acquisition is expected to add $190 million to Thermo Fisher’s 2011 revenue results.

Marc N. Casper, President and CEO of Thermo Fisher, commented that the acquisition of Phadia “significantly enhances our presence in high-growth specialty diagnostics markets by adding leading allergy and autoimmunity diagnostic tests.”

He added: “We look forward to working together to expand our depth of capabilities for our customers who are focused on improving healthcare through better diagnostics.”

Based in Sweden, Phadia develops, manufactures and markets blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune disease. It supplies more than 70% of allergy laboratory tests worldwide.

Based in the USA, Thermo Fisher Scientific is a world leader in serving life science within healthcare companies, hospitals, clinics and research institutions.

Two new low-profile devices for treatment of ischaemic stroke that can gain access to formerly inaccessible blood clots in the brain have received CE Mark approval.

The MindFrame Capture LP device for clot extraction and the MindFrame Flow LP device for flow restoration can be deployed through microcatheters as small as 10/14.

By enabling neurovascular surgeons to remove blood clots and restore normal blood flow in very narrow vessels, the stent-like wire mesh devices could help to prevent irreversible loss of brain function in patients suffering from strokes.

“This unique device technology offers improved ability to access thrombus through tortuous blood vessel anatomies, allowing for rapid perfusion and thrombus retrieval,” said Tommy Andersson, Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.

“The MindFrame LP devices allow me to restore blood flow and preserve brain function for my patients, providing the potential of being the standard in ischemic stroke treatment.”

Kenneth Charhut, President and CEO of MindFrame Inc, commented that the new devices “represent the next generation in device technology”.

Based in California, MindFrame Inc specialises in developing medical technologies for patients suffering from ischaemic stroke.