Norgine calls for NHS to not class constipation a 'minor' illness

by Hannah Alderton 28. March 2018 13:38

Norgine has expressed concern about the inclusion of constipation as a "minor" illness in new NHS England proposals to cut GP prescribing for certain health conditions. 

The inclusion of constipation, alongside other conditions such as dandruff, trivialises what can be a very serious condition. The consultation classifies constipation as "infrequent" or "minor". However, these are not medically recognised classifications and we consider that this lack of clarity will only serve to increase the variation that this consultation seeks to address. All chronic and serious constipation begins with what would be here described as "infrequent" or "minor". Similarly, "infrequent" constipation may also be very serious. 

Anton Emmanuel, Consultant Neuro Gastroenterologist at University College Hospital and the National Hospital for Neurology and Neurosurgery said: "Although constipation is a very common condition, it is a very serious one. For those suffering, it can result in serious quality impairments in quality of life and, if inappropriately treated, is associated with significant costs in the form of unplanned admissions to emergency departments. Serious health issues often start with minor symptoms. It is essential that patients are encouraged to visit their GPs to discuss their symptoms and to receive the most appropriate advice and treatment. I am very worried that these proposals will actively discourage patients from speaking to their GPs."

Dr Penny Dobson MBE, Chair, Paediatric Continence Forum added: "The Paediatric Continence Forum (PCF) has significant concerns that NHS England's proposals to restrict the prescription of laxatives for infrequent constipation could result in children with constipation not receiving appropriate treatment, and the very real and concerning risk of this condition deteriorating into the serious condition of impaction."

Peter Martin, COO at Norgine said: "We strongly believe that NHS prescribing, for whatever medical condition, should be made based on clinical need - and not the ability to pay. Including constipation in these proposals is the thin end of the wedge - exacerbating health inequalities, reducing patient outcomes, and eroding basic NHS principles."

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UCB inject patient confidence

by John Pinching 25. October 2016 10:08

UCB has announced that the new certolizumab pegol (Cimzia®) AutoClicks® Prefilled Pen is now available on the NHS, following the recent positive opinion by the European Medicine’s Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The EMA’s CHMP decision recommended the use of the pen in all approved indications (rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis [AS] and axial spondyloarthritis [axSpA]). The positive opinion was based on validated data and risk benefit analysis.

Meanwhile, UCB is continuing its partnership with OXO - a company known for consumer-friendly designs - to develop the AutoClicks® Prefilled Pen, based on core technology licensed from Bespak. The pen provides a button-free delivery system, a wide non-slip grip and a large viewing window that shows the progress of an injection.

Dr Ravik Mascarenhas, Consultant Rheumatologist at the Royal Devon & Exeter Foundation Trust, said, “I see many patients whose joints have been destroyed by this painful disease, so having a new choice is welcomed. Like most of us they also tend to find it a challenge self-injecting because of a needle – with this new pre-filled pen the patient doesn’t even see the needle which may take some of the nerves and fear away.”



Nazeri is new Novo Nordisk Director

by John Pinching 19. October 2016 11:31

Novo Nordisk has announced Avideh Nazeri as the new Director, Creative Medical Research for UK/Ireland.

She will be arriving from Malaysia, where she most recently worked with Novo Nordisk BA South-East Asia as the Director of Clinical, Medical, Regulatory & Quality (CMRQ). In this role she was responsible for driving strategy across 14 countries and six affiliate offices.

Avideh is an Endocrinologist and has worked at the King's College London, before joining industry in 2006. She started with Novo Nordisk Iran as Medical Manager and, in 2008, moved to work at Global Medical Affairs in Denmark. During five years as Global Medical Director she was responsible for the portfolio of modern insulins, faster aspart and Semaglutide. Avideh then moved to Novo Nordisk Canada, as Head of Medical Affairs, where she stayed for seven months and managed to integrate two new functions - KOL engagement and learning programmes - to Medical Affairs. The team established accredited field medical education with extensive reach across Canada. Avideh then relocated to Malaysia, where she has been for the last three years.

After living in nine different countries Avideh is extremely excited to be coming back to the UK.


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Acrimony as angered ABPI axe astounded Astellas

by John Pinching 24. June 2016 12:32

While the nation reels from its EU exit, Astellas UK has got its own worries to contend with. Today the company has been suspended, with immediate effect, from Association of the British Pharmaceutical Industry (ABPI) membership.

The suspension was enforced following a ‘serious matter’, which emerged during a PCMPA investigation into two complaints regarding the payment of clinicians to attend meetings in Europe.

Astellas UK and Astellas Europe had both been initially reported. The company has denied any deliberate wrongdoing.

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New finance head for Thorn Medical

by Amy Schofield 26. April 2016 11:00

Thorn Medical PLC has appointed Roderick Stead as Group Finance Director.

Stead joins the international healthcare group from PTS Consulting, where he served in a number of roles including Chief Financial Officer, Chief Risk Officer, and Non-Executive Director.

Jack Kaye, Thorn Medical's Chief Executive, said: "We're delighted to welcome Roderick Stead to the Board as Group Finance Director. His experience in fundraising and international acquisitions will be a great help to achieving our challenging global expansion plans."

Stead added: "Thorn Medical has ambitious plans for growing the company rapidly to become a major international force in the medical and healthcare arena and I look forward to working with the team to ensure its success."

Thorn Medical is an investor and acceleration partner which acts as an aggregator of innovative medical technology, pharmaceutical products and healthcare services businesses.

Image: Roderick Stead, Group Finance Director, Thorn Medical PLC (PRNewsFoto/Thorn Medical PLC)

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NICE U-turn on Sanofi's prostate cancer therapy

by Amy Schofield 26. April 2016 08:07

Sanofi has gained a positive recommendation for cabazitaxel from NICE after increasing the discount and taking steps to reduce waste.

NICE has issued final guidance recommending cabazitaxel (marketed as Jevtana by Sanofi) for some prostate cancer patients, in a change from the appraisal committee’s draft guidance.

The committee previously did not recommend cabazitaxel because of concerns about its cost-effectiveness compared with standard treatments such as abiraterone, enzalutamide or radium-223 dichloride.

Sanofi increased the discount in response to the draft guidance. The company also committed to reducing waste by confirming that it can supply cabazitaxel in intravenous bags instead of vials. These actions led to NICE's new positive recommendation and cabazitaxel is now judged a cost-effective treatment option.

Between 2013 and 2015, over 550 patients accessed cabazitaxel (as a second-line treatment after docetaxel chemotherapy) through the Cancer Drugs Fund (CDF). Cabazitaxel will now move into routine use and out of the CDF. The number of patients receiving the treatment is not anticipated to change as a result of the move.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "I am very pleased that this improved discount for cabazitaxel means we are now able to recommend it. This is an excellent example of how pharma companies can work with us to ensure that patients have access to all of their treatment options.”

One a treatment receives a positive recommendation from NICE, the NHS is legally obliged to begin funding it within three months of the final publication date.

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AstraZeneca secures US launch for Zurampic

by Amy Schofield 25. April 2016 18:10

AstraZeneca has entered into a licensing agreement with Ironwood Pharmaceuticals which includes US rights to Zurampic® and lesinurad/allopurinol fixed-dose combination in gout.

The agreement confers the exclusive US rights to Zurampic (lesinurad) to Ironwood. Zurampic was approved by the US Food and Drug Administration (FDA) in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

Ironwood will additionally gain the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the fixed-dose combination programme for regulatory review in the second half of 2016.

Ironwood will pay AstraZeneca sales-related and other milestone payments of up to $265 million and tiered single-digit royalties on product sales. AstraZeneca will manufacture and supply Zurampic, provide some support and services to Ironwood and undertake the FDA post-approval commitment on their behalf.

Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “Our new agreement with Ironwood will ensure the successful launch of Zurampic in the US, while allowing us to concentrate our resources on the innovative medicines in our main therapy areas.”

The licensing agreement is expected to close in the second quarter of 2016, subject to antitrust approval in the US.



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J&J Ebola vaccine shows promise in first human study

by Amy Schofield 21. April 2016 09:18

The first human study into J&J's experimental Ebola vaccine has found 100% immune response eight months later.

Administration of the vaccine from Johnson & Johnson, called AdVac, boosted by a second immunisation shot from biotechnology company Bavarian Nordic A/S, generated a powerful immune response among volunteers in its first tests in humans.

This study, published in the Journal of the American Medical Association, found that 100% of people getting the one-two combination were still producing antibodies against the virus eight months later. 

The novel approach may provide durable protection against the Ebola virus which swept across parts of West Africa in 2014, killing over 11,000 people and infecting almost 29,000.

The study of the vaccine’s real-world effectiveness is a challenge because Ebola isn’t currently circulating in large numbers. The World Health Organization declared an end to the public health emergency last month.

The companies are instead working to confirm the vaccine's safety and further test the immune system’s response in preparation for the possibility of another outbreak or emergency. 

Johnson & Johnson's Chief Scientific Officer Paul Stoffels said: “If there is a large epidemic, we should be able to use it to study the efficacy. Hopefully we will never need it, but if it is a problem, we’ll be ready to step in.”

With this new approach, the first shot is used to prime the immune system and the second boosts the response, perhaps creating a longer benefit.

The research was funded in part by the U.S. National Institutes of Health and grants from a European consortium that includes the London School of Hygiene & Tropical Medicine, the University of Oxford and the French National Institute of Health and Medical Research.



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GSK opens UK respiratory manufacturing facility

by Amy Schofield 21. April 2016 08:24

GSK has opened a £56 million manufacturing facility in Ware, creating 150 new UK jobs.

The company created the state of the art facility in response to growing export demand for GSK’s portfolio of respiratory medicines delivered by the Ellipta inhaler.

The new 4500m2 facility was opened by UK Life Sciences Minister George Freeman MP and GSK Chief Executive Officer Sir Andrew Witty. It is the latest expansion for Ellipta manufacturing at Ware, with investment totalling over £100 million over the past five years. More than 400 jobs have been created at the site since 2013, including over 30 apprentice and 50 graduate roles, forming the total workforce of 1200.

The new facility is expected to almost double production of Ellipta inhalers at Ware to at least 37 million per year by 2017. 95% of these will be exported.  

GSK's CEO Sir Andrew Witty said: "We have been leaders in respiratory since the 1960s when we first began making inhalers for the treatment of respiratory diseases in Ware and it continues to be a critically important site for us, both in terms of researching and developing innovative new inhaler technology, and as a world-leading manufacturing hub. The new facility will increase capacity to meet growing demand for our new portfolio of respiratory medicines worldwide.”

George Freeman MP said: “As well as driving growth and creating 150 new jobs, this expansion of GSK's medicines manufacturing facility in Ware is a strong endorsement of the UK's leadership in manufacturing and respiratory medicine."

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Solid Q1 2016 growth for Roche

by Amy Schofield 20. April 2016 09:07

Roche has reported solid sales growth in the first quarter of 2016, with Pharmaceutical Division sales up 4%, driven by oncology and immunology medicines. 

Group sales are also up 4% at constant exchange rates, 5% in Swiss francs, while Diagnostics Division sales grew 5%, led by immunodiagnostic product demand.

The growth in sales in the Pharmaceuticals Division were driven by Perjeta, MabThera and RoActemra. Pharmaceuticals sales in the US increased, led by Esbriet, Xolair and HER2-positive breast cancer medicines. The recently launched medicines Cotellic in skin cancer and Alecensa in lung cancer are reported to be doing well initially. In the US, sales of Tamiflu and Lucentis declined.

The main growth contributors in the International region were Avastin, MabThera and Herceptin at 4%. In Japan, sales rose 4% driven by Avastin, HER2 medicines and Alecensa.

The US FDA has also granted priority review for investigational cancer immunotherapy medicine atezolizumab in advanced bladder cancer and lung cancer and breakthrough therapy designation for ocrelizumab in multiple sclerosis.

Roche CEO Severin Schwan said: “We have started the year with solid growth in both our Pharmaceuticals and Diagnostics Divisions. Overall, we are on track to meet our full-year targets for 2016.”

Roche expects sales to grow at constant exchange rates in 2016. 


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