Devices meet drugs in Sanofi and Medtronic diabetes alliance

by Admin 17. June 2014 12:10

Sanofi and Medtronic have entered an alliance to develop drug-device combinations to boost adherence among diabetes patients.

Sanofi recently announced a new partnership with the world’s leading medical technology firm to develop products that help diabetes patients manage their conditions.

Medtronic is to join the pharma company in an open-innovation model alliance that will harness the human and financial resources of both companies, bringing together Sanofi’s drugs and Medtronic’s expertise with insulin pumps and other diabetes support devices.

Joint development projects will include exploring drug-device combinations and delivery of care management services to improve adherence. The pair will also seek to simplify insulin treatment to help diabetes sufferers better manage their condition.

Pascale Witz, executive vice president of global divisions and strategic development at Sanofi, described the alliance as “an important collaboration” between the two leaders and one that would enable Sanofi to “tap into technology advances that aim to create holistic treatment solutions which take into account the individual patient’s needs.”

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'Don't forget to polish your glasses', says NHS Scotland to old folk

by Admin 17. June 2014 11:39

NHS Scotland has been criticised for producing a “patronising” handbook for elderly people.

A new guide published by NHS Scotland to help elderly people avoid falling has been deemed “patronising” by a number of elderly support organisations after advice included reminding older people to polish their glasses.

The guide, entitled Up and About, runs to 48 pages and offers practical advice to help elderly people avoid tripping and falling. NHS Scotland developed the guide with the support of various charities and printed 40,000 copies – at a cost of £14,000 – for distribution countrywide.  

However, the guide prompted criticism for its ‘patronising’ tone after including recommendations such as avoiding alcohol, throwing away old slippers and slowing down at corners to lessen the chance of falling.

Eddie MacDonald from the Scottish Pensioners’ Forum said: “We consider much of the terminology and language used in the publication to be patronising and demeaning to [elderly peoples’] intellect.”

Paul Green, Saga’s director of communications, described the advice as “patronising and bloody obvious”, adding: “Just because someone is elderly, it doesn’t mean their common sense has abandoned them.”

Despite the criticism, NHS Scotland defended the new guide, stressing that the advice had been developed with the input of elderly people and offered practical advice in a style that suited the audience.

“[The guide] reflects their concerns and is written using the language and tone they use to describe their own experiences,” said a spokesman.

AgeScotland also spoke out in support of the document, with the charity having been involved in the development process, and deemed the finished product practical and user-friendly.

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Boehringer earns quality ‘kite mark’ for information

by Admin 17. June 2014 10:51

Boehringer has become the first pharma company to earn a kite mark for the quality of its health information for patients.

Boehringer Ingelheim has been awarded The Information Standard (TIS) certification for the quality of its healthcare information, becoming the first pharmaceutical company to get the kite mark for the standard of its materials.

TIS, commissioned by NHS England, serves to identify accurate and up-to-date information amid a sea of potentially unreliable sources, especially on the internet.

Ann Robinson, director of public awareness for TIS, said: “With so much information available now, it is vital the public be able to differentiate between information that is and isn’t trustworthy.”

TIS has recently attracted healthcare charities such as the Alzheimer’s Society and NHS trusts, although Boehringer is the first pharma company to earn its kite mark for information quality.

 Dr Charles De Wet, Boehringer’s medical director for the UK and Ireland, said the company had applied for TIS to “make it clear to patients and their families and carers that the information we provide is of high quality.”

“We are committed to providing a holistic approach to care. And to do so it’s vital that all parties have the right information at the right time,” added Dr De Wet.

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Artificial pancreas could treat diabetes

by Admin 16. June 2014 17:47

Trial results have shown that a “closed loop” insulin delivery system, which acts like an artificial pancreas, can safely be used unsupervised by patients overnight at home for several weeks.

UK researchers revealed the results of the first long-term trial of its kind at the American Diabetes Association conference this week. They showed that the closed loop ‘artificial pancreas’ improved glucose control in patients with type 1 diabetes and that the device was practicable for home use.

The closed loop system monitors glucose levels and uses a software algorithm to adjust insulin levels given by a pump every 12 minutes. A small device is connected to the body through a standard insulin pump, and this delivers insulin under the skin without the need for continuous injections.

Systems such as this have previously only been used in medically-supervised research settings, but the new study involved 25 adult patients assigned to receive four weeks of overnight closed-loop insulin delivery showed that compared to a standard insulin pump, where insulin delivery is pre-programmed, the closed loop system continuously measures sugar levels and automatically responds by making fine adjustments to the insulin infusion rate in response. 

People with type 1 diabetes do not produce any insulin, so they need to have insulin administered at the right level to avoid their blood sugar levels becoming too low (hypoglycaemia), which is a particular problem overnight.  Hypoglycaemia can cause a variety of symptoms, including agitation, confusion, altered behaviour, and eventually loss of consciousness. Hypoglycaemic episodes can often occur at night.

Researchers from the Universities of Cambridge, Sheffield and Southampton, and King’s College London found that the device improved blood sugar control overnight and was not associated with hypoglycaemic episodes. The research was funded by Diabetes UK and published in the peer-reviewed medical journal The Lancet.

The researchers concluded that “unsupervised overnight closed-loop insulin delivery at home is feasible and could improve [blood sugar] control in adults with type 1 diabetes”.

Longer-term studies examining the safety and effectiveness of the closed loop delivery system in larger numbers of people with type 1 diabetes are now needed.

 

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Positive trial data for Sanofi diabetes drug

by Admin 16. June 2014 15:04

Sanofi has announced positive results for its phase III clinical trial data of its new type 2 diabetes drug Toujeo.

The pooled analysis of three trials from the Edition programme revealed that Sanofi's new therapy consistently showed significantly fewer low blood sugar events at any time of day or night, compared with an approved and established alternative.

The data from three differing type 2 patient populations made up the pooled analysis, with all three studies meeting their primary endpoint by demonstrating a strong blood sugar control performance.

A high number of diabetes patients go through a “sensitive phase” when beginning insulin treatment which leads to them stopping treatment or failing to properly up-titrate when experiencing low blood sugar events. New therapies that can combat this problem are of significant importance in the management of diabetes. 

Pierre Chancel, senior vice-president of Sanofi’s global diabetes division, said: "We continue to be encouraged by the positive phase III results from Edition, which demonstrated the potential of Toujeo to help meet unmet needs of people living with diabetes."

 

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Supplier award for top sales team

by Admin 16. June 2014 13:48

Congratulations to the global outsourced healthcare service provider, Ashfield Commercial and Medical Services, which has received the “Lilly Global Supplier Award” for its UK-based Discovery syndicated sales team.

The awards presentation took place at Lilly’s corporate headquarters in Indianapolis, Indiana, where Ashfield’s Mary Anne Greenberg, Regional President North America, and Tom Mitchell, Project Manager for the Discovery Team, picked up the award on behalf of the crack UK sales team.  

The Ashfield Discovery Team received one of the eleven annual awards presented as a result of nominations made by Lilly procurement departments all over the world.

The team was awarded the accolade after coming out top in activity, selling skills and healthcare professional feedback. As a syndicated sales team, the Discovery Team offers an agreed percentage of customer contact time from shared representatives.

Ms Greenberg said: “The Discovery Team is representative of many of the teams in Ashfield where a culture of restless dissatisfaction leads to innovative approaches. Tom and his team keep raising the bar year after year. We’re very proud.”

Mr Mitchell added: “Since our start in the spring of 2010, the Discovery Team has consistently performed on behalf of Lilly. We are extremely proud to have our efforts recognized in this fashion.”

 

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Welsh GP services will ‘collapse’ without additional funding

by Admin 16. June 2014 11:37

General practice in Wales is at risk of ‘collapse’ without additional funding to support doctors struggling with the rising demand for services.

The chair of the Royal College of GPs (RCGP) in Wales has warned that general practice will “collapse” without additional resources from the government, as under recruitment and an ageing population increases the pressure on stretched services.

Dr Paul Myers, chair of the Welsh RCGP, said that problems with recruitment and a rising workload for GPs were being exacerbated by a drop in primary care funding, urging the government to allocate additional resources or see the services crumble.

“The problem is really serious,” said Dr Myers. “What I am hearing from practices really reflects my own experiences in terms of an increase in workload and a lack of resources.”

The RCGP is asking the government for an increase in funding by 2017 or “there is a danger general practice will collapse.”

Dr Myers’ comments follow warnings from the chair of the British Medical Association’s Welsh General Practitioners Committee that GP services were in “intensive care”.

Speaking during an annual conference last month, Dr Charlotte Jones described general practice as being “in crisis”, with the difficulty in recruitment causing problems for services throughout the country.

She also criticised the government for failing to act: “The Welsh government cannot simply stick its head in the sand hoping it will go away.”  

A spokesman from the government acknowledged the issues in general practice recruitment and said they were currently working with other professional organisations on plans to ensure Wales was promoted as “an attractive place to live and work”.

The plans include “developing new training and recruitment schemes for GPs, considering different contractor models and looking at how the skills of the whole primary care team can be better used.”

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Positive data for new insulin drug

by Admin 16. June 2014 10:56

Lilly and Boehringer Ingelheim have reported positive clinical trial data for their investigational insulin glargine product LY2963016.

The positive data were announced at the American Diabetes Association scientific sessions in San Francisco. Data from six completed phase I and phase III studies was shared, which showed that the new agent produced comparable clinical results to their currently marketed insulin glargine Lantus. It works similarly in the body and has the same amino acid sequence.

Lilly and Boehringer Ingelheim have been collaborating on the development of diabetes therapies since 2011.

An LY2963016 insulin glargine data package will be submitted for approval as a biosimilar in most geographic agencies. It has already been submitted to several global regulatory regions including the US, Europe and Japan.

Dr Gwen Krivi, vice-president at Lilly Diabetes Development, said: "This is one step closer to providing an important insulin glargine option to physicians and patients."

 

EMA agrees policy on clinical trial data publication

by Admin 16. June 2014 10:21

The European Medicines Agency (EMA) Management Board has taken an important step towards achieving increased transparency in the regulation of medicines in Europe.

The EMA has agreed the policy on publication of clinical trial data, together with more user-friendly amendments.

The policy, proposed by EMA Executive Director Guido Rasi, will not only allow the agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also allows the possibility to download, save and print the trial data for academic and non-commercial research purposes.

The wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to formal written adoption by mid-July 2014. The policy will be effective from 1 October 2014. 

The agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.

The agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests since the inception of its plans for the proactive publication of clinical trial data.

After an extensive initial consultation phase, the agency carried out a second round of targeted consultation in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access.

The policy takes the agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines.

 

 

OBE for Oberoi

by Admin 13. June 2014 16:52

One of the country’s most inspirational entrepreneurs, Kavita Oberoi, has been awarded an OBE.

In the recent honours list drawn up for the Queen’s birthday, Kavita Oberoi, founder of Oberoi Consulting, has been awarded an OBE for services to Entrepreneurship and Start-Up Businesses.

Oberoi, who has a multitude of experience and generated a net worth of £10m through her varied endeavours, is being rewarded for her years of work and for serving as an inspiration for various would-be entrepreneurs to pursue their ambitions.

Speaking upon the announcement of the honours list, Oberoi said: “It’s a huge honour to receive such an accolade. I was quite taken aback when I heard the news and must admit that I didn’t quite believe it at first, actually I had to ask one of my staff to read the letter out again!”

Oberoi graduated from Huddersfield University with a Chemistry degree in 1992 and subsequently worked in the pharmaceutical industry before taking the leap into entrepreneurship.

Her portfolio is diverse, from investing in a security firm and two call answering companies to launching an enterprise academy to support students in their business aspirations.

Oberoi founded Oberoi Consulting in 2001 and the company has since grown to become a leading provider of clinical audit services, technology, consultancy and clinical systems training services in the UK.

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