The European Commission (EC) has granted a marketing authorisation for Xgeva (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumours.

The decision is based on three Phase III trials that evaluated the effectiveness of XGEVA versus zoledronic acid at delaying SREs.

Willard Dere, Senior Vice President and International Chief Medical Officer at Amgen, says the injection “promises to make a real difference” to cancer patients.

Xgeva was also granted an additional year of data and market exclusivity since the indication was considered new, and based on the significant clinical benefits when compared with existing therapies.

The SRE clinical trials spanned more than 50 types of tumour in excess of 5,700 patients. The trials demonstrated a clinically meaningful improvement in preventing SREs compared to zoledronic acid.

“Skeletal-related events associated with bone metastases are truly devastating and painful for patients living with cancer, and today's approval of XGEVA marks a real advance,” said Professor Ingo Diel, Institute for Gynecological Oncology, SPGO, Mannheim, Germany.

“In clinical trials XGEVA demonstrated sustained protection from SREs and also delayed the progression of pain. These factors will make a genuine difference in the lives of patients living with advanced cancer.”

Teva Pharmaceutical has completed the full acquisition of Japanese firm Taiyo in a $934 million cash deal.

The deal for the generics manufacturer follows an agreement in May this year which saw Teva purchase a 57% share in Taiyo for $460 million.

Shlomo Yanai, President and CEO of Teva, says the acquisition is an “important milestone” for the company.

Israel-based Teva is the largest generics company in the world and had aimed to increase its presence in Japan. The deal will see the company add more than 550 products to its existing portfolio and meets its Japanese strategy.

There is a relatively low generic market in Japan, although it is now being actively encouraged by the Japanese government.

Taiyo currently has annual sales of approximately $530 million with Teva now expecting to exceed its original 2015 target of exceeding sales in the country of $1 billion.

“The acquisition of Taiyo, along with Teva’s existing Japanese business, assures that Teva will deliver on our strategic objective of becoming a leading player in Japan,” said Shlomo Yanai.

McCann Healthcare Worldwide has appointed the experienced Michel Nakache as its new Executive Vice President (EVP) for Europe.

He replaces the outgoing Mark Worman after enjoying a career in healthcare communications within the pharmaceutical and healthcare industries which spans three decades.

John Cahill, CEO of McCann Healthcare Worldwide, says the appointment of the new EVP will “help elevate McCann Healthcare Worldwide to the next level of pre-eminence throughout Europe”.

Mr Nakache started his career with Searle before joining GSK in both sales and marketing roles in the Gastroenterology, Cardiology and Dermatology categories. He has since become President and CEO of a number of European organisations, including the AACC Sante – the French Healthcare Communications Agencies Association.

“All my energy and experience will be devoted to McCann Healthcare Europe and McCann World group,” said Michel Nakache.

“In this transforming world, health and healthcare are of course essential. And the McCann people that I have already met are fantastic, so there is a very good foundation on which to build.”

EMD Serono has appointed James Hoyes as its new President.

In his new role he will be responsible for driving the strategic direction of the commercial organisations, as well as managing the business on a daily basis.

Mr Hoyes says he is “proud” to have joined the company and looks forward to “delivering successful business outcomes, and to driving medical advancements”.

The company is the US affiliate of Merck KGaA.

The new President first joined the company in February 2004 as Vice President of Marketing in neurology. He then led the neurology franchise prior to becoming the Chief Commercial Officer. Before joining EMD Serono, he had a variety of commercial roles at Elan, Sanofi and Sterling Drugent.

Dr Stefan Oschmann, member of the Executive Board of Merck KGaA and President of Merck Serono, says the company will benefit from Mr Hoyes’ years of experience. “He has a strong knowledge of the industry and expertise across a variety of commercial functions, including sales, marketing, communications, managed markets, and collaborations,” he said.

“We are confident that Jim will enhance the reputation of EMD Serono as a leader in biopharmaceuticals in the US.”

NICE has decided against recommending Lucentis (ranibizumab) for the treatment of diabetic macular oedema (DMO) in final draft guidance.

Its independent Appraisal Committee said that Novartis had underestimated the incremental cost-effectiveness ratio (ICER) when compared to standard treatment.

Sir Andrew Dillon, NICE Chief Executive, says the cost model for the injection was based on “implausible assumptions” which “significantly underestimated the cost of treatment”.

In its submission the Committee said that Novartis had only accounted for the treatment of Lucentis in one eye for a proportion of people with DMO. Concerns were also raised that data supplied on glycaemic control was much better in the trial population than it is in clinical practice, about the amount of Lucentis that patients would need, and that Novartis’ assumed benefits of the drug were “unrealistic”.

Lucentis is injected into the eye and decreases oedema limiting visual loss. It has been shown in clinical trials to be an effective treatment by DMO, but NICE says it had doubts on how much the treatment would cost the NHS.

“The manufacturer’s analysis produced a cost per QALY gained that was at the upper limit of the range NICE considers to represent an effective use of NHS resources,” said Sir Andrew.

“The Committee considered that, had a more plausible set of assumptions been used, the resulting cost per QALY gained would substantially exceed this range.”

Final guidance is now expected in August 2011.

Health Technology Assessment (HTA) processes do not speed up the access of medicines to patients or result in better rewards for products with a higher therapeutic value, a new report says.

A comparative analysis of the role and impact of Health Technology Assessment found that there are significant areas of improvement needed to accelerate patients’ access to new innovative medicines and technologies.

The report says that the link between assessments and access decisions needs to be improved but there are reasons to be optimistic given that many HTA systems are developing or evolving.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio, Medicines Australia and the Pharmaceutical Research and Manufacturers of America (PhRMA) commissioned the study of HTA process and outputs against best practice.

Little evidence was found that current systems increase access of new medicines or technology and that pricing and reimbursement authorities do not always implement recommendations from HTA bodies. In fact, in many cases, the overall link between HTA and pricing and reimbursement remains unclear.

Recommendations by health regulators on the same products also vary between different systems and countries. Research also revealed variations in how the same products are evaluated and suggested inefficiencies and inconsistencies linked with diverging methodologies and data requirements.

Evidence also highlighted that analysing the full healthcare system and associated costs for society would be more beneficial in terms of efficient allocation of resources than many systems suggest.

Despite assessments having the potential to help patients and healthcare professionals in making informed decision, societal aspects were not taken into account effectively by regulatory bodies and patients had a limited role in several HTA systems.

The four associations that commissioned the report will now continue their assessment of HTA processes to create future reports with the aim to move towards a truly patient-centred healthcare system.

Health Secretary Andrew Lansley says a switch to clinically-led local commissioning is the only way the NHS will meet future challenges.

Mr Lansley highlighted four major obstacles the NHS faces within the next decade that only a switch in commissioning will help transform.

He told delegates at the NHS Confederation’s conference that the NHS has “to increase productivity; to improve patient care; to reshape how care is delivered; and to integrate care around the needs of patients”.

The Secretary of State for Health had originally proposed that GPs take responsibility of the majority of the NHS commissioning budget. But after extension criticism of the plans and several amendments following the NHS Future Forum’s recommendations, Mr Lansley says he is still optimistic his vision of the health service can still be delivered.

“The pause is over. It’s now time to act,” he added.

The European Commission’s approval of Amylin’s diabetes drug Bydureon is expected to create jobs at its US manufacturing facility on Trade Port Drive, West Chester.

The once-a-week type II diabetes drug gained its first approval anywhere in the world last month and is expected to enter the UK and German markets by October.

Alice Izzo, an Amylin spokeswoman, says the demand for the product will determine how many new roles are created at the manufacturing facility.

The facility is the only manufacturing plant that the pharma company owns and will now switch from producing drugs made for clinical trials to those entering the market. Currently 300 employees work at the Trade Port Drive plant.

“It’s the first approval anywhere around the world, so it’s great progress for us and the facility in West Chester,” said the Amylin spokeswoman.

Bydureon is a once-weekly version of its twice-daily formulation Byetta, its biggest selling drug that lowers blood sugar. It is pending approval from the FDA, after two requests were made for further data on the safety of the drug last year. An application was also submitted recently in Japan.

Industry veteran and the founder of Celgene Dr Sol Barer has joined Inspire’s board of directors.

Dr Barer brings with him more than 30 years’ experience within the industry and will focus on addressing unmet need in the treatment of heart attack patients.

Asher Holzer, co-founder and President of Inspire, says it is an “honour to add such an accomplished and recognised biotechnology leader” to the company’s board.

It was in 1980 that Dr Barer formed Celgene. During his time with the company he occupied the positions of President, COO, CEO, Executive Chairman and Chairman before his retirement last month.

He also serves as a director at Amicus Therapeutics, Aegerion Pharmaceuticals and ContraFect Corporation.

Initial proposals on how the reformed commissioning structure will work have been published by the DH.

Developing the NHS Commissioning Board outlines how Clinical Commissioning Groups (CCG) will be supported regionally by clinical networks and nationally by the new NHS Commissioning Board – set to be named NHS England.

Sir David Nicholson, NHS Chief Executive, says that the CCGs will be the “cornerstone” of the commissioning process and aimed to create “continuity” for staff working in the current system.

He emphasised that the proposals remain subject to the passage of the Health and Social Care Bill through Parliament. However, he wanted to make clear the Government’s plans to “develop the organisation” in the meantime.

The report says the Board will have a wide range of powers and functions. The most important of these include:

• Delivering improved outcomes
• Overseeing the £80bn commissioning budget
• Commissioning directly £20bn on services
• Supporting quality improvement by promoting Quality Standards
• Promoting innovation, equality and diversity
• Developing commissioning guidance
• To champion patient interest, and
• Developing a medium-term strategy for the NHS to form the basis for local commissioning plans.

“The new NHS Commissioning Board will ensure the new architecture is fit for purpose and provides clear national standards and accountability – it will put the ‘N’ in NHS,” said Sir David. “The Board will lead the delivery of improvements against the NHS Outcomes Framework and offer more choice and control for patients.”

The new commissioning structure will be built over the next two years with CCGs becoming the “engine of the new system”.

Initial plans to shift commissioning to GP consortia were met with fierce criticism and led to the Prime Minister David Cameron announcing a listening exercise and creation of the NHS Future Forum to gauge opinion from healthcare professionals across England.

The Forum recommendation’s led to the commissioning consortia scrapped in favour of CCGs which will include at least one nurse and one specialist doctor.

Mr Nicholson says that the new proposed plans gives “pride of place” to clinical leaders and that leadership by experienced clinicians is “written into the DNA of the new system”.