Eli Lilly has won its first trial over health risks concerning its anti-psychotic drug, Zyprexa.

It is the first of 40 outstanding patient lawsuits involving the medication that claim the company concealed the drug’s side effects from patients and doctors.

Approximately 31,000 patient lawsuits were originally filed, most of which were covered by a $1.2 billion settlement, leaving 110 patient claims pending in 40 lawsuits.

The case in Los Angeles was filed by the family of a 20-year-old student who died while taking Zyprexa. They said that Lilly hid the medicine’s safety risks whilst marketing the medication for both approved and off-label uses in the US.

The lawsuit also claimed that the pharmaceutical company trained its sales representatives to counteract questions regarding risks of weight gain and diabetes linked to Zyprexa.

In addition to its settlement deal of $1.2 billion, Lilly also paid $1.42 billion for federal off-label marketing investigations and $260 million for state claims.

University College Hospital (UCH), London has purchased the UK’s first Biograph mMR hybrid molecular MR system (pictured) from Siemens Healthcare.

In the same month, the hospital’s Institute of Nuclear Medicine brought together clinical scientists to celebrate its 50^th anniversary.

The Biograph mMR – one of the first to be installed in Europe – will be housed in the UCH Macmillan Cancer Centre and used for diagnosis and planning of patient treatment, as well as research.

The world’s first simultaneous whole-body PET-MRI scanner. the Biograph mMR has won the red dot design award 2011 and the Frost & Sullivan Best Practices Award 2011 for its integrated design and scanning capabilities.

At the Institute of Nuclear Medicine’s 50th anniversary, Bruce Rosen, Professor of Radiology, Health Sciences and Technology at Harvard Medical School, gave a lecture on the future of combined PET and MR.

UCH Chairman Richard Murley thanked the UCLH Charity for funding the purchase of the new scanner.

Professor Peter Ell, former Head of the Institute of Nuclear Medicine, summed up half a century of medical imaging, including the first European nuclear medicine brain scanner in the 1970s; the first dedicated mobile renal function apparatus in the 1980s; and the introduction of PET-CT in cancer management.

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.

NICE has failed to recommend Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab) for advanced melanoma, deeming its £80,000 price tag too costly.

NICE’s Appraisal Committee based its decision on clinical data that suggested the drug could be very effective for a small percentage of patients with advanced skin cancer who have received prior chemotherapy – but it was unknown how long this effect would last.

Sir Andrew Dillon, Chief Executive of NICE said: “We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.”

Clinical specialists said that approximately 30% of people treated with the medicine would have improved survival, with 10% potentially experiencing long-term benefits.

Sir Andrew added: “Unfortunately, no patient characteristics or biomarkers have yet been identified to help identify this small group of people most likely to gain long-term benefit from receiving ipilimumab.”

The Committee also cited that Yervoy is associated with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.

BMS expressed its disappointment at NICE’s rejection, and have stated it will submit further evidence “in the hope that NICE will reconsider this decision so that all patients with metastatic melanoma can access this potentially life‐extending treatment”.

“In a deadly disease with no standard of care, where inclusion in a clinical trial has been considered one of the few treatment options available to patients, Yervoy represents a significant innovation in treatment,” said Amadou Diarra, European Vice President and General Manager at BMS UK.

Dr Pippa Corrie, Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust, commented: “Treatment for metastatic melanoma is a huge unmet need, with many patients facing a life expectancy of 6‐9 months. It is essential that we all work to avoid any negative impact on facilitating patient access to this drug. Our patients have waited too long already.”

Consultees are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer will be able to reduce the acquisition cost of £80,000 to the NHS for ipilimumab by proposing a Patient Access Scheme.

BMS gained approval to market Yervoy in the US in March 2011, with an approval from the European Commission in July. The drug was launched in the UK in August 2011, becoming the first licensed treatment for advanced skin cancer since the 1970s.

There are approximately 40,000 deaths worldwide from skin cancer, with the number of cases predicted to double from 138,000 a year to 227,000 by 2019.

Pfizer has signed a pact worth $340 million with GlycoMimetics, in a lead drug programme for sickle cell disease.

The partnership will see Pfizer focus on the development of GMI-1070, an inflammation inhibitor for the painful vaso-occlusive crises that threaten the organs of sickle cell patients.

Yvonne Greenstreet, Senior Vice President and Head of the Medicines Development Group at Pfizer, said: “This experimental compound and partnership are emblematic of our strategy in rare disease, targeting areas of high unmet need to deliver improved patient outcomes.”

The deal states that Pfizer owns worldwide commercial rights of the treatment, with Maryland-based GlycoMimetics taking charge of the Phase II trial before passing it over to Pfizer’s development team for further studies.

GMI-1070 is also being tested in preclinical studies for other diseases, including haematologic malignancies.

A new CPAP (continuous positive airway pressure) device from Philips Respironics could enable people with obstructive sleep apnoea (OSA) to manage their own condition more effectively.

The new REMstar Pro (pictured) with AutoIQ is able to track the patient’s sleep breathing over several nights, establish or readjust to a set airway pressure, and check back periodically to adjust the pressure as needed – without clinician intervention.

The first phase of the AutoIQ mode, Auto-Trial, uses an algorithm for a total of 30 days to establish the patient’s treatment needs. At the end of the phase, the device analyses the data to identify and deliver the best airway pressure for the patient.

Following that, Auto-Check checks back every 30 hours to see how the patient is progressing and to automatically adjust the pressure if needed.

Auto-Trial days can be saved to reassess therapy at a later date if the patient’s physical condition or sleeping environment changes.

Throughout the process, AutoIQ keeps the care team informed of the patient’s sleep breathing performance and CPAP compliance.

“REMstar Pro with AutoIQ demonstrates our ongoing pledge to providers and their patients to be their ally in better sleep and breathing,” said John Frank, General Manager for Sleep and Respiratory Care, Philips Home Healthcare Solutions.

“By providing intelligent solutions and advancements in technology, we are shaping the future of sleep therapy.”

Philips Respironics is a unit of Royal Philips Electronics of the Netherlands, a market leader in cardiac care, acute care and home healthcare.

A new smart phone application is being developed, that can measure heart rate, heart rhythm, respiration rate and blood oxygen saturation from the patient’s fingertip.

The new app uses the phone’s integrated video camera, and is claimed to be as accurate as standard medical monitors currently in clinical use.

Authors of the study at Worcester Polytechnic Institute (WPI), Massachusetts, USA, stated: “This gives a patient the ability to carry an accurate physiological monitor anywhere, without additional hardware beyond what's already included in many consumer mobile phones.”

“One of the advantages of mobile phone monitoring is that it allows patients to make baseline measurements at any time, building a database that could allow for improved detection of disease states.”

The application, developed by Ki Chon, Professor and Head of Biomedical Engineering, and colleagues at WPI, analyses video clips recorded while the patient's fingertip is pressed against the lens of the phone's camera.

The camera's light penetrates the skin, reflecting off blood in the finger. The device’s technology is able to link subtle changes in colour with changes in the patient's vital signs.

Chon’s team of researchers is also developing a version of the mobile monitoring technology for use on video-equipped tablets.

“We believe there are many applications for this technology, to help patients monitor themselves, and to help clinicians care for their patients,” Chon said.

The UK Government’s Department of Health called for new healthcare app ideas in August 2011.

A new point-of-care analyser for blood gases and other solutes, launched worldwide, promises quicker and easier diagnosis in the critical care environment.

The RAPIDPoint 500 Blood Gas System (pictured) from Siemens Healthcare Diagnostics delivers reliable results in 60 seconds and allows rapid identification of the patient and operator.

The new system aims to meet the growing demand for POC blood tests that can be used rapidly and easily by a wide range of clinicians.

The RAPIDPoint 500 analyser has a cartridge that lasts up to 28 days, with a full complement of critical-care tests for blood gases, pH, electrolytes, glucose and lactate-1, as well as full CO-oximetry, from a single whole-blood sample.

Features to enhance ease of use include:

• fully automated calibration and quality control
• a self-contained Automatic Quality Control cartridge that operates without manual intervention
• an integrated bar code reader with a wide scanning area for patient and operator identification.

The new medical device can be integrated with the Siemens RAPIDComm Data Management System to enable centralised management of multiple Siemens blood and urine analysers in critical care monitoring.

“The RAPIDPoint 500 system is designed to satisfy the unique demands of testing at the point of care,” said Dr. David Stein, CEO, Point of Care Business Unit, Siemens Healthcare Diagnostics.

“In addition to being easy to use, the analyser leverages proven and reliable cartridge-based technologies to deliver fast, accurate, laboratory-quality results, helping clinicians feel confident in making critical decisions.”

Belfast Health and Social Care Trust has licensed a new rapid meningitis diagnostic test for worldwide exclusive marketing rights.

The new test, developed by scientists at the Royal Victoria Hospital and commercialised by Irish start-up company HiberGene Diagnostics, uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP), that can to provide reliable diagnosis within an hour.

Meningitis is a difficult disease to diagnose as symptoms are typically flu-like. Standard laboratory tests take at least 24 hours to process, and there is a need for rapid and accurate results to allow earlier confirmation to enable earlier treatment.

Brendan Farrell, CEO of HiberGene Diagnostics said: “We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7% which is excellent.”

Consultant Paediatrician Professor Mike Shields, who led the research, said: “Meningitis presents a clinical challenge for the emergency department doctor because the patient's symptoms can be non-specific.

“No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available it will have the potential to save many lives.”

HiberGene Diagnostics Ltd is a start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at the University College Dublin.

The company plans to market the test in the first half of 2012 and is in discussions with potential distribution partners in the US and Europe.

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.