The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

Bristol-Myers Squibb and Gilead Sciences have signed a licensing agreement to develop and commercialise a potential fixed-dose combination single pill for the treatment of HIV.

The combination would include BMS’ protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s pharmacoenhancing agent cobicistat.

Elliott Sigal, Executive Vice President, Chief Scientific Officer and President, R&D, BMS, says the pill has the potential “simplify HIV therapy” and address unmet needs for innovative treatment options.

The combination is currently being studied in Phase II and Phase III studies in HIV-1 treatment-naive patients.

Reyataz is a prescription medicine used in combination with other medicines to treat people aged 6 years of age and older who are infected with HIV. Gilead’s cobicistat is a boosting agent that increases blood levels of certain strains of the virus.

Under the terms of the agreement, BMS will be responsible for the worldwide formulation, manufacturing, development, registration, distribution, and commercialisation. It will pay Gilead an undisclosed royalty based on the annual net sales of the product when released.

“This collaboration with Gilead builds on Bristol-Myers Squibb’s longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options,” said Mr Sigal.

Gilead will retain the sole rights for the manufacturing, development and commercialisation of cobicistat as a stand-alone product and for any future combinations with other agents.

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.”

Lux Biosciences has formally withdrawn its marketing authorisation for Luveniq (voclosporin).

The company stated in its official letter that they were unable to demonstrate to the CHMP that the benefits of the medication outweigh its risks.

But it added that the withdrawal does not have any consequences on any current clinical trials or compassionate use programs.

Luveniq was intended to be used as a treatment option in those with chronic non-infectious uveitis involving the posterior or intermediate segments of the eyes as characterised by a high degree of inflammation.

The medication was designated as an orphan medicinal product in September 2007. The centralised marketing authorisation was first submitted to the EMA in February last year. It received a negative opinion by the CHMP in June this year which saw Lux submit a re-examination request in July.

Roche is to merge with and fully acquire oral therapeutics developer Anadys Pharmaceuticals in a $230 million cash deal.

The acquisition follows Roche’s plans to expand future treatment options for patients with hepatitis C virus (HCV) infection.

Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development, said: “Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure.”

San Diego-based Anadys’ most advanced drug candidate, Setrobuvir (ANA598), is a direct-acting antiviral (DAA) inhibitor, which is currently being evaluated in a Phase II study in combination with Roche’s Pegasys (pegylated interferon) and Copegus (ribavirin).

Roche plans to explore Setrobuvir’s use in combination with other DAAs already within its portfolio, with and without interferon.

Steve Worland, President and CEO of Anadys, said: “With Roche’s considerable capabilities and experience in HCV, this acquisition provides the best chance of success for the new potential treatments our team has been dedicated to developing.”

In addition to its lead programme with ANA598, Anadys is developing ANA773, an oral, small-molecule inducer of innate immunity that may prove useful for treating HCV as well as other chronic infections and cancer.

Headquartered in Basel, Switzerland, Roche provides research-focused healthcare with strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotechnology company with focus in oncology, virology, inflammation, metabolism and CNS medicines.

The CHMP has given a positive opinion to Novo Nordisk’s basal insulin analogue Levemir as an add-on treatment in patients with type 2 diabetes.

The opinion is based on a clinical trial where, as an add-on therapy to Victoza, in combination with metformin, reduced glycated haemoglobin (HbA1C) and sustained weight loss were demonstrated.

Alan Moses, Global Chief Medical Officer at Novo Nordisk, says the decision provides an “additional treatment option” for patients who need more options to achieve personalised glucose targets.

Meanwhile, the Committee has also adopted a positive opinion on the extended use of the insulin in children aged between two and five years old with type 1 diabetes.

It reviewed data that showed children treated with Levemir plus a fast-acting insulin analogue experienced a lower rate of all-day and nocturnal hypoglycaemia when compared to those taking human basal insulin and insulin aspart.

Dr Nandu Thalange, Norfolk and Norwich University Hospital, says that when treating children their safety must always come first and welcomed the CHMP’s decision. “Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes,” said Dr Thalange. “Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed.”

Novo Nordisk now anticipates that the European Commission will shortly approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes and extend the marketing authorisation to make the insulin detemir the only basal insulin analogue for the use in this young patient group with type 1 diabetes.

Levemir, Victoza and NovoRapid, another insulin therapy by Novo Nordisk, contributed to a profit increase of 27% for the company in 2010.

The FDA has approved Remicade to treat moderately to severely active ulcerative colitis (UC) in children older than six years in the US.

Janssen Biotech’s infliximab treatment is indicated to reduce the signs and symptoms of UC in patients whose condition has not responded to conventional therapy, aiming to induce and maintain clinical remission.

The approval was based on findings from a multi-centre, randomised, open-label study involving 60 children aged six to 17 years old with moderately to severely active UC who have failed to respond to or tolerate conventional therapy.

Dr Donna Griebel, Director of the Division of Gastroenterology and Inborn Errors Products at the FDA, said: “With the approval of Remicade, children with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option.”

Remicade carries a Boxed Warning for risk of serious infections and cancer. These infections include tuberculosis and those caused by viruses, fungi or bacteria.

The drug is already approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children older than six years, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis and plaque psoriasis in adults.

UC is a form of inflammatory bowel disease (IBD) that affects the lining of the large intestine and rectum. Between 50,000 and 100,000 children in the US have IBD, with 40% of this figure having UC.

Trobalt (retigabine) has joined the options available to the NHS for the treatment of controlling seizures in adults who have epilepsy.

NICE has advised that the drug be used as an add-on treatment option if several other recommended medicines have been ineffective or produced unmanageable side effects.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE says the Institute is pleased to offer final guidance “so soon after retigabine’s regulatory approval”.

The GSK drug was licensed by the EMA back in March.

Epilepsy is a common neurological disorder characterised by recurring seizures, which affects between 260,000 and 416,000 people in England and Wales – more than half will experience partial onset seizures.

Sufferers of the condition usually need to take a combination of drugs to control their seizures. In the guidance, NICE recommends Trobalt as an add-on treatment for those who have not responded to the following: Tegretol (carbamazepine), Frisium (clobazam), Neurontin (gabapentin), Lamictal (lamotrigine), Keppra (levetiracetam), Trileptal (oxcarbazepine), Epilim (sodium valproate) and Topamax (topiramate).

“Seizures can be extremely debilitating as they can interfere with a person’s social life, employment and other daily activities,” said Professor Longson.

“While there are a number of effective anti-epileptic drugs already widely available on the NHS, people can have different responses to them. It’s therefore very important for doctors to have a broad range of options so that they can find the right combination for their patients.”

NICE has recommended two new treatment options for patients with multiple myeloma.

Celgene’s Thalidomide has been recommended as a first-line treatment in people where high-dose chemotherapy with stem cell transplantation is considered inappropriate. If the patient is intolerable to Thalidomide, Janssen’s Velcade (Bortezomib) is then recommended.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, claimed that the new regimens have been shown to be “more effective at delaying disease progression and improving patients’ life expectancy.”

Multiple myeloma is a rare type of cancer that develops from cells in the bone marrow. Almost 4,000 cases are diagnosed every year in the UK.

Mike Hobday, Head of Policy at Macmillan Cancer Support, stated: “It is great news that NICE has recommended these drugs for cancer patients with multiple myeloma and that their needs have been listened to.

“For too long patients with less common cancers, such as multiple myeloma have lost out on receiving the vital medicines they need on the NHS.

“This decision recognises the need to fund drugs that improve the quality and length of life for cancer patients with rarer cancers, which is a key step to improving better access to treatments for all.”