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.

Breast cancer screening in the UK is under review following claims that it causes more harm than good.

The review will be led by Professor Mike Richards, National Cancer Director for England, who said he is taking the “current controversy very seriously”.

A recent review of clinical trials has said that for every 2,000 women screened in a 10-year period, one life would be saved, ten healthy women would undergo unnecessary treatment and at least 200 women would face psychological distress due to false positive results.

Susan Bewley, Professor of Complex Obstetrics at King's College London, who has turned down breast cancer screening, said: “The distress of overdiagnosis and decision making when finding lesions that might, or might not, be cancer that might, or might not, require mutilating surgery is increasingly being exposed.”

Screening programmes have helped doctors diagnose cancers earlier, but they also run the risk of false positives.

Breast cancer screening was introduced in the UK in 1988 and now offers tests to women over the age of 50 every three years.

The NHS says that 1,400 lives are saved every year through screening in England alone, and in 2002, the World Health Organization's International Agency for Research on Cancer estimated that screening reduced deaths from breast cancer by about 35%.

Chris Askew, Chief Executive at Breakthrough Breast Cancer, said: “The earlier breast cancer is picked up the better for the one in eight women who are diagnosed every year with this disease, as treatment options are more likely to be less aggressive and have successful outcomes.”

But Sara Hiom, Director of Health Information at Cancer Research UK, who is leading the review, said: “Women need more accurate, evidence-based and clear information to be able to make an informed choice about breast screening.”

The FDA has approved Abbott Molecular’s genetic diagnostic, Vysis EGR1 FISH Probe Kit, to detect acute myeloid leukaemia (AML).

The new in vitro test is the third of Abbott’s FISH assays to be cleared for oncology applications in the US in the past two months.

Stafford O'Kelly, Head of Abbott's Molecular Diagnostics Business said that the medical technology “can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient's overall prognosis”.

The Kit’s technology detects chromosomal deletion in the bone marrow, and can be used in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis to determine prognosis.

Each year, more than 12,000 people are diagnosed with AML, which is a rapidly progressive disease. Current standard procedure involves aggressive chemotherapy drugs, while some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.  

Part of Abbott, Abbott Molecular is a leader in molecular diagnostics, analysing DNA and RNA at the molecular level. Abbott Molecular's tests aim for earlier detection or diagnosis, to provide information of appropriate treatment, and improve monitoring of disease progression.

Abbott is a global healthcare company, which discovers, develops, manufactures and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and commercialises its products in more than 130 countries worldwide.

Janssen Pharmaceuticals’ protease inhibitor (PI) Incivo (telaprevir), to treat adults with genotype-1 chronic hepatitis C, has been launched in the UK.

The direct acting antiviral (DAA) PI uses telaprevir, a new class of medicine which directly targets the hepatitis C virus, offering patients further help with clearing the virus in combination with the current standard treatment of peginterferon alfa and ribavirin.

Professor Graham Foster at Queen Mary's University Hospital of London, said: “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”

The marketing authorisation of the therapy was based on clinical research gathered from three Phase III clinical trials involving more than 2,290 hep C patients. Results showed that Incivo cured the virus in almost twice as many previously untreated patients and in almost four times as many who had previously relapsed following treatment.

Incivio was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceuticals and the company responsible for marketing telaprevir in Europe.

Approximately 216,000 to 466,000 people are infected with chronic hepatitis C in the UK, of which only 80,000 have been diagnosed. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome.

The European Commission approved use of Incivo for to treat genotype-1 chronic hepatitis C virus in combination with peginterferon alfa and ribavirin in September 2011.

The ABPI has welcomed a DH proposal to improve access to medicines for rare diseases – but cautioned against an increase in the use of unlicensed drugs.

The new initiative plans to commission expert assessments of off-label and unlicensed medication to inform doctors and patients before prescribing them – focusing in particular on hard-to-treat conditions such as rarer cancers and autoimmune diseases.

Stephen Whitehead, Chief Executive of the ABPI, said that the ABPI recognises the lack of licensed medicines for rare diseases, and that there can be important clinical reasons why people should be prescribed an unlicensed or off-label drug.

But he said that it is always “preferable for a medicine to be licensed for the purposes for which it is used and has been subject to the rigorous scrutiny of the regulatory authorities”.

“The regulatory and licensing system in the UK exists to protect the public, so the circumstances when an unlicensed or off-label medicine is prescribed should continue to be strictly limited to occasions where there is no suitable licensed alternative available and use is in the best interests of the patient concerned.

“We look forward to engaging with all government and healthcare stakeholders in the months to come to help shape the implementation of these proposals, and ultimately, improve patient access to new, innovative medicines”, he said.

On average, 1,000 specific requests for off-label drugs are made to NHS commissioners every year.

The application of a bio-decontamination programme, including the use of hydrogen peroxide vapour (HPV), by Gloucestershire Hospitals has reduced the incidence of Clostridium difficile infection.

In three years, the Trust’s infection control programme – which includes the use of cohort wards and antibiotic control as well as UK company Bioquell’s HPV technology – has achieved a 65% reduction in C. difficile infection rates (from 771 cases to 267).

C. difficile (pictured) is the leading cause of hospital-acquired diarrhoeal disease in the UK, and its control is a major target for healthcare professionals.

Over the three-year period, 2,763 areas were decontaminated using HPV within the hospital. HPV can eradicate all biological contamination, providing a clean environment for patient re-admission.

C. difficile endospores are usually resistant to decontamination and can survive for months on hard surfaces, creating a reservoir of infection. The HPV process ensures complete surface sterilisation, breaking down endospores,

Deputy Nursing Director Paul Garrett commented: “HPV technology has played an important part in helping to reduce C. diff infection as part of an overall bundle of interventions. The Bioquell system has now been successfully integrated into the daily operations of our hospitals.”

Based in Hampshire, Bioquell is a leading supplier of bio-decontamination equipment and services, including its unique HPV technology.

The marketing authorisation for Zytiga (abiraterone acetate) has been approved by the European Commission after an accelerated regulatory review process by the EMA.

The androgen biosynthesis inhibitor has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed.

Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, says its approval “gives new hope to men” suffering from the disease across Europe.

The fast-track review by the EMA followed a positive opinion by the CHMP in July.

Zytiga demonstrated in a pivotal Phase III study a 35.4% reduction in the risk of death and an improvement of almost four months in median overall survival.

“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain,” added Professor Fizazi.

Prostate is the third most common cause of cancer deaths in Europe. An estimated 370,000 new cases were diagnosed across Europe, resulting in the deaths of nearly £90,000 men.

Four new-generation cardiac computed tomography (CT) scanners from leading diagnostic imaging companies are recommended in draft guidance from NICE’s Diagnostics Assessment Programme.

The provisional recommendations support the use of the following CT scanners in the NHS:

• Somatom Definition Flash CT (Siemens Healthcare)
• Aquilion ONE (Toshiba Medical Systems)
• Brilliance iCT (Philips Healthcare)
• Discovery CT750 (GE Healthcare).

The draft NICE guidance recommends the use of these CT scanners for first-line imaging of coronary arteries in people with suspected coronary artery disease who are difficult to image with earlier-generation CT scanners and who are considered at high risk (10–29%) of having the disease.

It also recommends their use in people with known coronary artery disease for first-line evaluation of disease progression to establish the need for surgical intervention where use of earlier-generation scanners is difficult.

Recent NICE guidelines on acute chest pain recommend CT (as well as invasive) coronary angiography to diagnose coronary artery disease in people considered at high risk (10–29%) of the disease.

However, people with complicating factors such as a high calcium score, obesity, arrhythmias, tachycardia or previous coronary stents or grafts, are difficult to image using earlier CT technologies.

The new-generation cardiac CT scanners listed above have superior technical features enabling faster image acquisition, better image quality and lower radiation dose.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The independent Diagnostics Advisory Committee concluded that new-generation cardiac CT scanners are good value for money for hard to image patients instead of proceeding directly to initial angiography.

“The Committee acknowledged that, from a patient perspective, a non-invasive cardiac diagnostic test is preferable to invasive coronary angiography because of the risks associated with this type of test.”

The draft guidelines are now open for consultation with healthcare professionals, industry and patient groups. NICE is particularly keen, Professor Longson said, to discuss “this important new technology” in relation to the existing NICE guidelines on the diagnosis and management of angina.

Coronary artery disease caused an estimated 91,000 deaths in the UK in 2007.

Novartis has received approval from the European Commission for the use of Afinitor (everolimus) tablets to treat patients with advanced pancreatic neuroendocrine tumours (NET).

The decision was based on Phase III data which indicated the tablets more than doubled the time without tumour growth.

Hervé Hoppenot, President, Novartis Oncology, says the approval means thousands of patients “will have a new targeted approach” for the aggressive cancer.

The decision applies in all 27 European Union states, plus Iceland and Norway. Novartis are also currently seeking additional regulatory submissions across the rest of the world.

The RADIANT-3 Phase III trial was the largest clinical trial to date in advanced pancreatic NET. Results found that Afinitor reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced stages of the disease.

An improvement in progression-free survival was also found in all patient subgroups, including those who had not received prior chemotherapy.

Afinitor is currently approved in the EU for the treatments of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

It is also approved in Europe for the non-oncology patient population under the trade name Certican for the prevention of organ rejection in heart and kidney transplant recipients.

Leicester University has developed a new ‘Star Trek-style’ medical suite to help diagnose hospital patients with potentially serious diseases.

The £1 million ‘sick bay’ aims to assess patients more quickly, reducing the number of time-consuming and uncomfortable blood tests.

Professor Paul Monks, who helped develop the new facility, said: “We want to free doctors to actually treat patients and this technology enhances that ability.”

The medical bed assimilates the “ultimate non-invasive diagnostics”, which Star Trek fans will recognise, said Professor Monks.

“Dr McCoy in Star Trek had a tricorder that he waved over the patients to help diagnose diseases.”

Professor Tim Coats, a consultant at the hospital, said that the non-invasive technology uses one group of instruments to analyse the patient's breath, while a second group uses imaging originally intended for exploring the surface of Mars, while a third looks inside the body to measure blood flow.

The new high-tech facility has taken three years to develop, and promises to improve detection of serious diseases such as cancer, heart failure and infections. Professor Monks said: “We’ve shown that it can detect lung cancer quite early.”

Leicester Royal Infirmary plans to use the new equipment within two weeks in its Accident and Emergency department.