Study: statin risks ‘outweigh benefits’

by Admin 24. September 2014 09:13

The risks associated with statins outweigh the benefits according to the findings of a new study.

The study found that statins increase weight and blood sugar levels and raise the risk of diabetes. The basic mechanism of the cholesterol-lowering drugs, taken by around seven million people in the UK, can modestly increase the risk of diabetes.

Statins have previously been associated with higher rates of type 2 diabetes, but it was not clear whether it was the drugs that were responsible or another factor.

However, experts said the benefits of taking statins still greatly outweigh the risks and advice on taking the drugs should remain unchanged.

Scientists analysed genetic data from up to 220,000 people and results from almost 130,000 patients who had taken part in earlier statin trials.

The study authors found that those taking statins experienced a modest 12% increased risk of developing type 2 diabetes over a four-year period, and on average gained around half a pound (240 grams) in weight.

Current clinical guidelines suggest that statins should be offered to people with a 10% or higher risk of developing heart disease in the next 10 years.

Lead researcher Dr Daniel Swerdlow, from University College London's Institute of Cardiovascular Science, said: ''The effects were very much smaller than from statin treatment, but the genetic findings indicate that the weight gain and diabetes risk observed in the analysis from trials are related to the known mechanism of action of statins rather than some other unintended effect.''

Professor Colin Baigent, deputy director of Oxford University's Clinical Trial Service and Epidemiological Studies units, said: ''Although it is helpful to understand mechanisms, this research does not change our assessment of the safety of statins.

"The magnitude of the benefits of statins arising from the prevention of heart attacks and strokes greatly outweighs any small risks of diabetes, so the current recommendations for statin use remain appropriate.''

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Drugs | News

NHS England introduces new telehealth programme

by Admin 23. September 2014 12:36

NHS England has unveiled a new telehealth programme to support the use of technology to improve patient outcomes.

In a letter to key health and care technology organisations, NHS England has introduced a new technology enabled care services (TECS) programme to encourage the use of technology to improve health care.

The new programme will focus on “creating the right commissioning environment to support and encourage the innovative use of technology to improve health outcomes for those with long term conditions and deliver more cost effective services”, explained an NHS spokeswoman.

As part of the programme, the health governing body seek to tackle the obstacles that prevent health organisations utilising technology, with plans to offer CCGs a ‘toolkit’ to ease the process of introducing telehealth across their services.

Dr Martin McShane, NHS England director for people with long term conditions, said addressing the issues faced by the commissioners represented “a significant culture shift in the way we operate.”

“Rather than telling people what to do, we are giving them the tools to do the right thing.”

The new telehealth approach is part of NHS England’s TECS Improvement Plan and replaces the 3 Million Lives project, introduced in 2011, which had vowed to see three million patients using telehealth by 2017.

Commenting on the replacement of the 3 Million Live project, the NHS spokeswoman said the health governing body retained a “commitment to make significant progress” towards the ‘three million’ target.

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News | NHS

New partnership to boost UK medicines manufacturing

by Admin 23. September 2014 11:42

The ABPI and BIA have entered into a new partnership to increase medicines manufacturing in the UK.

A new Medicines Manufacturing Industry Partnership (MMIP) has been established between the Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) to attract innovative medicine manufacturing to British shores.

The steering group for the new MMIP will be led by Ian McCubbin, senior vice president for North America, Japan and Global Pharma Supply Chain at GlaxoSmithKline, with other companies involved including Actavis, AstraZenenca and the Knowledge Transfer Network (KTN).

Steve Bates, chief executive officer at the BIA, said: “The UK’s research and development capabilities are world class and we are now seeking to put medicines manufacturing on a similar footing.”  

Stephen Whitehead, chief executive of the ABPI, added that his organisation was “delighted to take a leading role in establishing this important initiative which will ensure the UK has the capability to be a global leader in medicines manufacturing”.

The MMIP will commence its task by working with a team from the KTN to help industry players understand and access the funding-mechanisms currently in place to boost the UK’s competitiveness as a medicines manufacturing destination.

Future plans include targeting the priority areas of technology, fiscal, regulatory and skills environment and promoting the benefit of UK-based manufacturing to the world. 

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General | News

EU approval for new cancer-fighting drug, Zydelig

by Admin 23. September 2014 11:09

Gilead Sciences’ new cancer fighting drug has been approved by the European Commission, consolidating the company’s expansion into oncology.

Zydelig is a drug, which will be used to combat two rare and incurable forms of B-cell cancers; chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL). While the drug is already available in the US to treat patients with CLL and FL, it has also been used to treat small lymphocytic lymphoma (SLL), since July.

Taken orally, Zydelig can be used alongside Roche’s MabThera/Rituxan (rituximab) as a second-line treatment for CLL patients and also a first-line therapy for patients with a specific gene mutation (17p deletion or TP53 mutation). Like most cancer drugs, Gilead has warned of side effects including severe diarrhoea, pneumontitis and intestinal perforation.

Peter Hillmen of Leeds Teaching Hospitals NHS Trust has said “Zydelig is a welcomed treatment option that offers a new approach in the management of these cancers.”

Despite facing competition from Roche’s Gazyvaro (obinutuzumab), approved in Europe last month, the company is hopeful Zydelig will establish their much sought out portfolio in oncology in Europe, expanding their focus beyond infectious diseases

Regeneron’s allergy drug is a star in the making

by Admin 23. September 2014 10:15

Regeneron’s research chief hints the company’s new allergy drug could be the next big thing.

An experimental allergy drug being developed by Regeneron is being touted by the company as a future performer following a successful trial in which asthma flare-ups were reduced by 87%.

Trials of the drug in eczema patients also recorded success, with symptoms and service area diminished by 45-74% when patients were given the treatment.

The drug, dupilumab, has been developed in collaboration with Sanofi and targets the causes of allergies such as asthma, eczema and nasal polyps. The drug works by inhibiting two proteins that attack healthy tissue and cause the allergic reactions experienced by sufferers.

George Yancopoulos, research chief at Regeneron, said: “We have a lot of debate within the company as to which of our many programmes is the most exciting, and a lot of people are voting on dupilumab.”

The company is set to launch a new cholesterol-lowering treatment, alirocumab, in 2015 but Regeneron’s head of business development Michael Aberman predicts dupilumab “could be bigger because we believe we are getting to the crux of all these diseases”.

Regeneron are currently waiting on the results of a trial on patients with nasal polyps in order to fully appraise dupilumab’s full potential. 

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Mixed response from Janssen to NICE verdict on Hep C drug

by Admin 22. September 2014 15:44

Janssen has expressed mixed feelings to the Appraisal Consultation Document1 (ACD) from the National Institute of Health and Care Excellence (NICE) for the use of Olysio® (simeprevir).

Janssen welcomed the news that the NICE Appraisal Consultation Document for simeprevir has recommended its use for the treatment of chronic hepatitis C genotype 1 infection; however, the pharma firm is "disappointed" that it has not recommended its use in the other two of its three licenced indications.

Data from clinical studies have demonstrated the efficacy of simeprevir in patients with genotype 4 infection, when used in combination with pegylated interferon and ribavirin. Simeprevir is also licenced in combination with sofosbuvir, thus providing a much needed treatment option for patients who are unable to tolerate interferon-containing regimens. Each of these patient groups includes a small number of patients who have an unmet medical need for alternative treatment options.

The veto from NICE for the use of simeprevir with sofosbuvir means that patients who are unable to tolerate an interferon-based regimen with genotypes 1 or 4 hepatitis C will not have access to the new therapy. Janssen expressed concerns that these patients will have to wait further until new therapy combinations are approved, during which time their disease may progress, with the potential development of permanent liver damage such as cirrhosis or cancer. Concern over the additional risk of onward transmission was also raised. 

The decision by NICE is still preliminary, and Janssen has pledged to continue to work with NICE and other stakeholders to find a solution that will make simeprevir available for these patients.

Peter Barnes, Medical Director at Janssen, said: “We are pleased that simeprevir has been recommended for the treatment of patients with genotype 1 hepatitis C when used in combination with peginterferon and ribavirin. However, we are disappointed with the preliminary recommendations from NICE for genotype 4 patients and those who are intolerant to interferon, and could therefore benefit from the use of a treatment regime that does not include it.

"We believe there is an unmet need in these patient groups that simeprevir can help address and that our submission to NICE demonstrates the cost-effectiveness of its use. However, we will attempt to address NICE’s concerns around this evidence, and hope its position will change.”

The public consultation has now started and interested parties may submit a response through the NICE website. The deadline for response is the 9th October 2014.


Pfizer pledges support for immunisation in Africa

by Admin 22. September 2014 12:53

Pfizer has announced grant donations of approximately $2 million to provide support for African immunisation projects.

The donations will be provided by the Pfizer Foundation, a charitable organisation established by the company as a key element of its corporate social responsibilities. The money will support pilot programmes to improve the reach of immunisation coverage in Ethiopia, Malawi, Rwanda, Uganda and Zambia.

UNICEF, Save the Children and the International Rescue Committee are among the beneficiaries. The money provided by Pfizer will be used primarily to increase the capacity of African healthcare systems. The other priority is to ensure that sustainable vaccine supplies are available to the children who need them.

It is hoped that the grants will help to speed up progress towards reducing child deaths in sub-Saharan Africa to meet the targets set out in the UN Millennium Development Goals.

Susan Silbermann, president of Pfizer Vaccines, said: "Infrastructure challenges, security concerns and capacity limitations, among others, continue to be obstacles for last-mile healthcare delivery, including getting medicines and vaccines to people who need them when they need them."

Boehringer Ingelheim & CureVac to develop lung cancer therapy

by Admin 22. September 2014 12:21

News emerges from Boehringer Ingelheim of an exclusive global license and development collaboration with CureVac that will involve the creation of a new lung cancer therapy.

The deal will give Boehringer Ingelheim exclusive global rights for the development and commercialisation of CureVac's investigational therapeutic cancer vaccine CV9202. The therapy is currently in early clinical development for the treatment of lung cancer.

CV9202 is based on CureVac's mRNA technology, which combats cancer by prompting the patient's own immune system to fight the tumour with a specific immune response.

Boehringer Ingelheim will start clinical investigation of CV9202 in combination with afatinib in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), as well as in combination with chemoradiation therapy in patients with unresectable stage III NSCLC.

Professor Klaus Dugi, chief medical officer at Boehringer Ingelheim, said: "We are proud of our commitment to help improve the treatment of cancers with a high medical need. In our collaboration with CureVac, we will investigate combining existing treatments with the approach of sustained activation of the immune system."


Welsh hospital A&E “unsustainable” as junior doctors withdrawn

by Admin 22. September 2014 11:09

 Gwent hospital may be forced to close it’s A&E department over night as junior doctors are withdrawn from work.

The Wales Deanery intends to remove junior doctors from out-of-hours work at Ysbyty Ystrad Fawr hospital in Gwent, forcing the health board to consider closing the emergency department over night and at weekends.

Aneurin Bevan University Health Board has already had to reorganise staff rotas after junior doctors’ work was limited, with the latest announcement from the Deanery making the emergency unit “totally unsustainable”.

The Wales Deanery is responsible for overseeing junior doctors’ education and training, and the move to limit working hours comes in response to concerns that new staff are not receiving sufficient support or training.

A report from the health board has warned the move to withdraw junior doctors from out-of-hours work would result “in the hospital only being able to assess and admit patients between the hours of 8am and 8pm Monday to Friday, with the Medical Assessment Unit and the minor injuries unit having to close outside these hours”.

The health board is appealing to the Deanery to reconsider the decision, with local health watchdog Aneurin Bevan Community Health Council warning the Deanery’s decision could jeopardise the region’s key service re-organisation plans and impact quality of care at the hospital.

Cathy O’Sullivan, chief officer of the Community Health Council, said: “I would urge the Deanery not to take any drastic measures. Otherwise it may put patients and services at risk.”

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News | NHS

EU approval for Novo Nordisk’s diabetes combo

by Admin 19. September 2014 14:39

Novo Nordisk’s diabetes combination drug has been given the green light for marketing across the EU.

Following approval from the European Commission, Novo Nordisk will now be able to market its combination therapy for type-2 diabetes across the EU.

Novo Nordisk’s Xultophy is a daily single injection that combines Tresiba and Victoza and has been approved as a treatment for adults with type 2 diabetes. The drug can be used in conjunction with glucose-lowering oral drugs or basal insulin, with evidence suggesting that for patients only taking the latter, Xultophy can reduce HbA1c glycated haemoglobin by 1.9%.

Mads Krogsgaard Thomsen, Novo Nordisk’s chief scientific officer, said the new combination treatment “represents a new paradigm with the potential to transform how type 2 diabetes is treated”.

The company expects to launch Xultophy across the EU in the first half of 2015, with the drug having been granted approval in Switzerland earlier this month.

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