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New EMA approvals pilot under discussion
The European Medicines Agency (EMA) has met with a number of UK trade associations, politicians, payors and patients to discuss a new adaptive licensing scheme which is hoped, will speed up access to new treatments if adopted.
The new scheme would involve the early approval of a drug within a restricted population, which would be followed by so called "phases of evidence" - gathering and adaptions of the marketing authorisation to expand access.
In a recent meeting involving The Association of the British Pharmaceutical Industry, the BioIndustry Association and the Centre for the Advancement of Sustainable Medical Innovation a number of topics relating to the pilot were discussed including a view that pilot involves a “coalition of the willing” including regulators, payors, industry and patients “in a discussion in a safe harbour environment”. The BIA, ABPI and CASMI said in a statement that “there was great emphasis on the need for trust and open and honest dialogue between all involved and it was recognised that this approach now allows, an adaptive mindset, using multiple data sources to help patients”. This recognises “a shift from a blockbuster development strategy to one that considers smaller patient populations from the outset”, they said.
Those attending the meeting felt that the various bodies associated with the pilot would have the capacity to cope with any additional workloads and that agreeing on pricing and reimbursement would be an essential deciding factor in the success of the scheme.
This scheme certainly has the potential to improve a numbe of processes and to streamline the approval process, which can of course be of great benefit to the patient and indeed the pharmaceutical industry as a whole.
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AstraZeneca and Pfizer deal still not completely written off
The ongoing and developing story of Pfizer taking over AstraZeneca has been all over the media recently, including mainstream news channels and newspapers. Although the board of AstraZeneca rejected Pfizer's "final" offer of $120 billion, there are a number of investors and share holders who still want a deal to be struck.
Members of AXA and Legal and General among others have been pushing for the AstraZeneca board to accept Pfizer's offer of £55 per share, which AstraZeneca believe should be £58.85 per share, if the company is to be properly valued.
The two sides have until 5pm on the 26th of May to strike a deal, or else under British Takeover rules, the buyout must be shelved for 6 months until further talks will be permitted.
An AstraZeneca spokesperson had this to say of the Pfizer offer. "There is no possibility of any proposal at a price higher than set out in Pfizer's Final Proposal Announcement representing an indicative value of £55.00 per share being made prior to the PUSU Deadline, even with the consent or recommendation of the Board of AstraZeneca, absent the announcement of a higher competing offer by a third party."
It will be an interesting few days between now and the deadline, to see whether the deal will be dead and buried or if the demands of certain investors are answered and further negotiations take place. The main concern for those working in both companies is that a merger could lead to redundancies and cutbacks in R&D.
For more on this story see this Fierce Biotech article
KPMG suggests Pharma business model needs to change
KPMG's Chris Sterling giving a talk. Picture Source: article.wn.com
The global head of KPMG’s life sciences practice, Chris Stirling, has suggested that in order to maintain profits and a healthy industry, the Pharma sector needs to make big changes to its business model. According to the firm's research, return on R&D expenditure has halved in the past 20 years and the earnings ratios on products have also fallen dramatically.
Commenting on the findings Mr. Stirling said “The business model that has powered the pharma industry over the last few decades is showing signs of fatigue – costs are skyrocketing, breakthrough innovation is ebbing, competition is intense and sales growth is flattening”.
Mr. Stirling highlights a lack of focus on the patient and that there is instead an over-reliance on blockbuster products which as various reports have shown, are no longer giving the return on investment they once did.
“The current industry model does not put the patient at the heart of its decision-making. Judgements are instead driven by developments that create blockbuster products, which in turn are expected to drive blockbuster returns for shareholders. Such an approach demands an all-consuming focus on products, and all too often leaves the patient as an afterthought,” he says.
A number of pharmaceutical companies are beginning to realise that business methodologies need to change and that a patient-centric approach may just be the best option. Mr. Stirling talked about changing the system from a "value chain" to a "value ecosystem" whereby many aspects of a business are wrapped around the patient at its core.
“If the pharmaceutical industry is to capitalise upon this potential, it must innovate to develop new business models and find better ways to collaborate across the healthcare ecosystem – all the while putting the patient at the heart of everything it does,” concluded Mr. Stirling.
The findings and comments from KPMG are certainly interesting and have indeed been adopted by a number of industry leaders. It will be interesting to see if others follow suit and if governments and health bodies follow Germany's lead and become more strict on what products are granted marketing authorisation. Like any industry, Pharma needs to evolve to survive and that has always been the case. The challenges of global healthcare will always be there.
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New med-tech hub announced for the UK
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Mayor of London Boris Johnson today announced a £4 million plan to create MedCity, a medical sciences research sector to match the might of London's financial services sector and to compete with similar projects in Boston and Singapore.
The initiative will bring together the UK's so called "golden triangle" of medical research centres in London, Oxford and Cambridge in order to develop new treatments and provide a positive boost for the economy.
It is being funded by £2.92 million from the Higher Education Funding Council for England and £1.2 million from the Mayor of London’s Office. Boris Johnson has "no doubt" that MedCity will be able to perform as well as the financial services sector.
Deputy Mayor for business Kit Malthouse was also confident in the new plan, saying “We have created this incredibly powerful discovery engine. How do we turn that into cures? These things have to come out of academia and be turned into therapies and drugs. We have to find a solution to dementia. If we don’t find one in the next 30 years, it’s going to bankrupt the country. We have incredibly ambitious research being spun out in a patchy way....Having a strong, vibrant cluster of life sciences is good for London and the South-East.”
It's certainly an exciting development and one that should further strengthen the medical research abilities of the UK. There will need to be investments made in other regions at the same time however in order to prevent a further gap developing between the South East and the rest of Britain.
AstraZeneca teams up with UK Medical Research Council
There was a boost for the R&D industry in Cambridge with the announcement from AstraZeneca that they are to team up with the UK Medical Research Council (MRC) in a joint partnership in early-stage drug discovery and disease mechanisms research.
The new research facility will give academics "unprecedented access" to the company's in-house compound library and compound screening capabilities, said AstraZeneca in a statment.
Professor Sir John Savill, chief executive of the MRC, described the five-year agreement as a "unique collaboration" between industry and academia and represents a "long term investment in UK infrastructure".
The MRC and AZ have worked together in the past but this deal marks a significant increase and reflects the industry's increased moves away from in-house R&D efforts. Other companies including GlaxoSmithKline and Johnson & Johnson have set up similar partnerships and initiatives looking to utilise the wider scientific community in order to develop new treatments.
These new methods benefit both parties with the Pharma companies not needing to invest in expensive in-house research and the scientific community gaining access to state of the art equipment and expertise that may not be present in an academic environment.
Commenting on the new venture, Menelas Pangalo, executive vice president of innovative medicines and early development at AZ said "Through this collaboration AZ and the MRC will push the boundaries of science to accelerate drug discovery and the development of new medicines here in the UK".
It's encouraging to see increased transparency from the Pharmaceutical industry, with a growing willingness to involve the wider scientific and academic community in their research and development cycles. At the end of the day, it is the patient who stands to gain the most from such initiatives as wider collaboration is certain to lead to new and innovative discoveries. It will also help the next generation of pharmaceutical workers get a feel for industry and boost recruitment into the sector from academia.
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NICE begins consultation on assessment changes
The National Institute for Health and Care Excellence (NICE) has began to accept consultation for its new proposals on the way it assesses and makes recommendations for new medicines and treatments used by the NHS. Under the new proposals, two new elements would be introduced: the burden of illness and the wider social impact.
At present NICE utilises its appraisal committees to consider life-extending treatments at the end of life, whereas the new approach will look into this more systematically as the concept of burden of illness. The wider societal impact will look at the way patient's ability to interact with society is impacted by their illness.
NICE have made it clear that "protected" characteristics such as age, gender will not be used by committees as the basis for deciding on treatments offered by the NHS.
“We need to see increased predictability in the system and clearer frameworks on how decisions are made so that pharmaceutical companies and the NHS can appropriately plan around patients’ needs. The vital role of patients should not be overlooked by NICE when assessing medicines, and we hope the opportunity will also be taken to allow greater contributions from patients and clinicians in the appraisal decision-making process,” said Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry (ABPI)
The consultation process is scheduled to continue until the 20th of June, after which NICE will consider any changes before introducing the new system in the Autumn.
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Patients in the UK believe GP workloads are too high
In a new survey commissioned by the Royal College of General Practitioners (RCGP) it has been found that the UK public has concerns about their GP's ability to safely carry out their jobs. 62% of those surveyed feel the workload is too high and that the volume of patient consultations being carried out by GPs are undermining their ability to provide a high level of patient care.
28% of those surveyed said they could not get an appointment with their GP within the same week, which is of course cause for alarm, when early diagnosis can be essential in many cases. The amount of time spent waiting for a consultation was of concern to 40% of those surveyed.
“General practice as we know it is now under severe threat of extinction. It is imploding faster than people realise and patients are already bearing the brunt of the problem,” said Dr Maureen Baker, chair of the RCGP.
“We need proper provision in the 2014-15 budget rounds right across the UK so that GPs can give their patients the care they need. If this doesn’t happen, we have grave concerns for the sustainability of the NHS,” she continued.
New government initiatives such as the Better Care Fund have helped pave the way for improved treatments but there is still a lot of work needed to address this issue.
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Bayer to create over 500 new jobs in German manufacturing sites
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With a growing demand for hemophilia A treatments, Bayer is investing over €500 million in two of its manufacturing facilities in Wuppertal and Leverkusen, Germany in order to keep up with demand as well as to add additional supply options for two products currently undergoing clinical trials.
The two products, a plasma protein-free rFVIII (BAY 81-8973) and a long-acting rFVIII (BAY 94-9027) are presently in Phase III of the clinical trials process and the latter had some positive results from a recent PROTECT VIII trial.
At present, all of Bayer's hemophilia treatments are made exclusively in its facility in Berkeley, California, USA. With this investment the company plans to prepare for the anticipated launch of these two new products.
"This investment will be one of the largest in the history of Bayer HealthCare and reflects our strong commitment in the field of hemophilia A," said Dr. Olivier Brandicourt, CEO of Bayer HealthCare. As part of this investment Bayer HealthCare will create about 500 new jobs at its sites in Leverkusen and Wuppertal by the year 2020.
This announcement is further evidence of a growing confidence in the European pharmaceutical industry and shows that companies are investing more and more in facilities this side of the Atlantic.
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Circassia's IPO is biggest UK Biotech flotation in years
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With its initial public offering raising £200 million, Circassia has become the biggest Biotech IPO on the London stock market in decades. The company based out of Oxford in the UK has been valued at £581 million.
Chief Executive of Circassia, Steven Harries believes the success of their flotation shows that Biotech firms can be successful on both sides of the Atlantic. The IPO of Circassia was seen by many in the industry as a test bed to see if there could be big interest in Europe, traditionally playing second fiddle to the US when it comes to investment.
Commenting on the announcement, Mr. Harris said “There have been a number of companies like us that have been building privately for a long time. “The sector is certainly not as big as the US, but our science is world class and there is a critical mass we can build on.”
Circassia's listing is the first in the Biotech sector in 8 years and the largest since 1995 says industry publication EP Vantage. The money raised from the IPO will be used to invest in vaccines for alergic reactions such as cats, grass, ragweed and dust mites. They have a number of products about to undergo phase II trials.
This announcement will be encouraging news for the Pharmaceutical industry and will hopefully raise hopes of a resurgance in Biotech investment that will hopefully translate into other fields within the industry.
For more on this story see The Financial Times article here.
Sweden is the EU's biggest innovator finds European Commission
The European commission has compiled a list of the biggest innovators and ranks Sweden at the top of the list followed by Germany, Finland and Denmark. The UK has an average to above average score for innovation and finds itself in the same ranking as nations such as Austria, Belgium, Cyprus, Estonia, France, Ireland, Luxembourg, the Netherlands and Slovenia.
The EU leader when it comes to innovation, Sweden, is performing above the EU average for most indicators, and especially for international scientific co-publications, R&D expenditures in the business sector, public-private scientific co-publications and Patent Cooperation Treaty (PCT) patent applications in societal challenges. Its relative weaknesses are in sales share of new innovations and knowledge-intensive services exports
Although the US and Japan rank higher than the EU for innovation, the gap is getting smaller, despite some large differences in performances between differing EU member states. The main areas of progress are in the attractiveness of the EU research system, business innovation collaboration and the commercialisation of knowledge.
It will be important for the region to continue to increase its innovation abilities while maintaining successful revenues and the EU will have a major part to play in that process, ensuring the region remains competitive and not blocking innovation opportunities with potentially costly legislation.
Read more at: http://www.pharmatimes.com/Article/14-03-04/UK_is_an_innovation_follower_says_EU.aspx#ixzz2v1PXjDpK
Pharma industry calls for EMA pharmacovigilance fees review
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The European Federation of Pharmaceutical Industries and Associations (EFPIA) are one of a number of industry organisations to express concerns about the "increasing financial burden" for companies who pay into the EU Pharmacovigilance system.
A number of industry bodies including the EFPIA have called on the European Medicines Agency (EMA) to review their handling process for Pharmacovigilance payments to ensure a more balanced and transparent process.
The group, which includes the European Generic medicines Association (EGA), European biotech industry (EuropaBio), Association of the European Self-Medication Industry (AESGP) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) expressed concerns about rising costs for procedural fees which they feel have risen far more sharply than the originial calculated amounts from 2008.
The Pharma industry would like to see cost breakdowns, along with detailed information on performance indicators in order to better see the costs associated which at present, they feel are not in line with the EMAs ongoing efforts to be more transparent and accountable.
The EMA fees are up for legislative discussion later in the year and this issue is sure to be high on the agenda for the Pharma industry.
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EU funded project to investigate new antibiotics
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With antiobiotic resistance becoming an ever growing concern amongst health bodies worldwide, there is a renewed push to develop new treatments to fight back. In the last 30 years just two new classes of antibiotics have been brought to the market and more an more pathogens are developing resistance to the treatments available today, in particular Gram-negative pathogens like E.coli.
A new project dubbed ENABLE (European Gram Negative Antibacterial Engine) funded by the Innovative Medicines Initiative (IMI) will bring together over 30 universities and companies to develop the next generation of antibiotics. The initiative is being led by GlaxoSmithKline and Uppsala University in Sweden.
"Accelerated efforts like this with the goal of creating an entirely new family of antibiotics are unique. The commitment fills a long-standing gap: Funding for collaboration is needed for the discovery of new antibacterials if we are to be able to cope with infectious diseases in the future, says Anders Karlén", a professor at the Disciplinary Domain of Medicine and Pharmacy at Uppsala University, who is the scientific co-director of the project.
Antibiotics are costly to develop given the barriers that Gram-negative pathogens are able to develop against them. There is also the necessity to release any new product gently so as not to encourage resistance thus making a very expensive product almost useless. The Pharma industry will have to keep on top of drug resistance pathogens if we are to maintain a healthy society.
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EMA introduces tracking numbers for pre-authorisation process
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The European Medicines Agency, as part of its efforts to reorganise and streamline processes, is to introduce unique product identifiers (UPIs) for pre-authorisation procedures. From now on, companies approaching the EMA for the first time with a new product, paediatric development or scientific advice will need to register with the EMA for a unique UPI.
They will then need to use this UPI each time they contact the EMA on any matter relating to that product. UPIs will only be assigned to new medicines and will not affect products already being processed by the agency.
Like a number of industry bodies in the Pharmaceutical sector, the EMA is streamlining its procedures in order to be more efficient and speed up the process, that at times can suffer from inefficiences at various stages of the pre-authorisation process.
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European Type 2 Diabetes market set for consistent growth
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Type 2 Diabetes continues to present significant health problems in Europe with the number of diagnoses cases set to reach 64 million by the year 2030. This of course creates a healthy market for those developing treatments for the condition with revenues set to reach almost €16 billion in three years time.
The latest market insights report from Frost & Sullivan has highlighted the efforts being undertaken throughout Europe to successfully create treatment options. The key focus seems to be on creating strategic national plans with Germany, Italy and Norway developing their own strategies.
In the Nordics, Norway will be developing a National Strategy for Diabetes over the next two years. In Sweden they are hoping to develop a more patient-centered approach involving care, research and education. Finland has set the bar for its neighbours by developing a comprehensive diabetes program with regular checkups provided to patients.
It is clear that without proper education on the risks of diabetes that it will continue to be a problem not just in Europe, but worldwide. The figures from The International Diabetes Federation predicting an increase in cases of almost 10 billion in 15 years, shows that diabetes will continue to be a key area for the healthcare market. Pharmaceutical companies will certainly be kept busy researching new treatments and there are a number of new options currently undergoing or about to begin clinical trials.
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Latest PwC survey highlights Pharma CEOs thoughts and concerns
PwC have released their latest global survey of CEOs which includes those in the Pharmaceutical sector. Their findings reflect the issues felt by many in the industry with 64% feeling an inability to protect intellectual property is the biggest barrier to growth. Patent expirations and increased competition from generics has led to this growing concern in the industry.
In relation to staffing and recruitment, there is a fairly even split with approximately half of those surveyed feeling concerned by the lack of skilled employees and new entrants into the market. A number of respondents felt that emerging markets were another key aspect for future growth, with the majority not feeling too concerned by rising labour costs in those markets. One major area of concern was that of corruption and lack of trust in the pharmaceutical industry, with over 60% of those surveyed feeling concerned by corruption and more than half citing a lack of trust in business as being a worry.
Despite the issues being faced by the industry, confidence remains very high indeed with 90% of pharmaceuticals and life sciences CEOs stating that they were somewhat or very confident of growth over the next 3 years.
Regarding the protection of intellectual property, Joseph Jimenez, CEO of Novartis said "We believe that the protection of innovation in the form of intellectual property is being eroded in some countries and it worries us. Rewarding innovation and protecting intellectual property are the two things on my wish list when it comes to government support for business".You can see the full survey results on the PwC Site below including a detailed breakdown.
EMA praises SMEs for their innovation
A study published in Nature Reviews Drug Discovery has highlighted the impact that SMEs, academia, public bodies and public-private partnerships have had on the pharamceutical industry in recent years. Off all the innovative medicines granted marketing authorisation from the EMA's Committee for Medicinal Products for Human Use (CHMP), 40% originated from these smaller sectors.
SMEs accounted for 13% of these products, while 17% originated from academic institutions showing the power of third level research when it comes to discovering new and innovative medicines.
Commenting on their report, the researchers said ‘This analysis shows that SMEs, academic institutions, public bodies and public-private institutions represent an important source of innovation and bolster the product pipelines of larger companies,”
The EMA has described SMEs as a "motor of innovation" and has a number of incentives to encourage participation from the sector which allows them to compete with the larger players in the pharmaceutical industry.
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Novartis to cut more jobs says newspaper
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Swiss newspaper NZZ am Sonntag has claimed that Novartis will cut more jobs this year as part of a cost saving plan that has already seen 500 redundancies at a plant in Switzerland earlier this year as well as similar losses in the US.
Novartis posted their financial results from 2013 recently which showed a 3% dip in net profit, although sales were up by 2%. Not shying away from the planned cuts Novartis chief executive Joe Jimenez said: "cost containment is here to stay. This is something that started during the financial crisis, and it's not going away."
Despite these cost cutting measures in Europe, Novartis has recently acquired an office complex in India with a capacity of 8,000 which would in fact see their staffing numbers remaining mostly neutral after restructuring.
Cuts are a natural part of the industry these days and in the long term benefit the companies by streamlining resources, which over time leads to renewed growth. For instance since their last major job cut seven years ago Novartis has a significantly higher number of staff. And with promising new therapies on the horizon the future is still relatively positive for the Pharma industry.
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EMA begins publishing minutes of committee proceedings
Transparency has become something of a buzzword as of late with a number of leading pharmaceutical companies announcing their plans to make more information available to the public. The European Medicines Agency (EMA) has been working on a transparency strategy since July 2012 and the latest part of that is to release the minutes of certain committee meetings.
These are the Committee for Medicinal Products for Human Use (CHMP), as well as the Committee for Advanced Therapies (CAT), which covers areas such as gene therapies, cell therapies and tissue-engineered products in animals, and its Committee for Medicinal Products for Veterinary Use (CVMP).
The meetings held in December of last year have already been released and can now be viewed on the EMA site.
The minutes of these meetings will now be released on an ongoing basis. Transparency has been a contentious issue for the pharmaceutical industry with the EMA saying the current trend of increasing transparency, particularly in relation to clinical trials data is "irreversible".
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Antibody-Drug Conjugates emerging as the next big thing
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The Pharmaceutical industry is always looking for the next big thing, a new product that can become a blockbuster and make up for losses associated with patent expiration and increased competition from generics. The latest buzz word in the industry is Antibody-Drug Conjugates (ADCs) which work by attaching a drug to an antibody that target only the specific cells that are damaged and require treatment. The drug is not released until the target site has been reached thus avoiding healthy cells and providing a more effective treatment.
There are currently two products approved for use, Seattle Genetics’ Adcetris and Roche’s Kadcyla. The latter is expected to become a blockbuster. There are around 30 ADCs currently undergoing clinical trials and another 100 or so in a preclinical development phase.
The main issue with ADCs at present is the difficulty in manufacturing them with a limited number of manufacturers currently capable of doing so. This has led to increased investment such as Roche's new development in Switzerland aimed specifically at developing and manufacturing ADCs.
For a detailed overview of ADCs see:
New diabetes treatment approved in Europe
AstraZeneca and Bristol-Myers Squibb have announced that their type 2 diabetes treatment Xigduo™ has been granted Marketing Authorisation by the European Commission. Xigduo combines dapagliflozin (trade name Forxiga®), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of this kind.
“Xigduo is an important addition to the range of medicines to help patients manage glycaemic control. We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management,” said Elisabeth Björk, Vice President, Head of Late Phase Cardiovascular and Metabolic Development, AstraZeneca.
“Type 2 diabetes is a growing global concern and a range of treatments are needed in order to appropriately manage this disease,” said Fred Fiedorek, Senior Vice President, Head of Development – Cardiovascular & Metabolics, Bristol-Myers Squibb.
With diabetes becoming a growing concern worldwide this announcement will be welcomed by patients and physicians alike and should prove a valuable addition to the treatment options currently available.
More on this story here
New report reveals top social media Pharma companies
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Pharma companies have been cautious when it comes to social media and perhaps rightly so given the many legal aspects that can come with having a presence online. But some companies have jumped right in and embraced social media as part of their marketing efforts and customer engagement. A new report produced by the IMS Institute for Health Informatics has ranked the top pharma companies social media efforts based on a number of factors.
These are Reach (total number of people reached through each channel via likes, shares, re-tweets etc); Relevance (extent to which content is being shared and forwarded); and Relationship (amount of interaction between company and patient). They were judged on the three main social media channels, Facebook, YouTube and Twitter. Top of the pile was Johnson & Johnson with GlaxoSmithKline and Novo Nordisk in second and third respectively.
"Healthcare professionals, regulators and pharmaceutical manufacturers all need to overcome their reticence and acknowledge the vital role that they can and should play in contributing to the healthcare conversation," Murray Aitken, executive director of the IMS Institute, said in a statement.
Here's the full top 10 list
1. Johnson & Johnson
6. Boehringer Ingelheim
It's good to see big pharma actively engaging in social media practices but there are many still avoiding it altogether, with less than half of the biggest pharma companies having a social media presence. With a lack of concise and official guidance on social media, many companies are afraid to dip their toe in the water but with the majority of healthcare conversations taking place online, it's essential for companies to have a social media presence, so that they may engage with their customers and find out exactly what it is they need. This is at the end of the day, the essence of selling, identifying the needs of the customer and selling them the ideal product.
You can download the full IMS report here
New eHealth plan backed by European Parliament
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The European Parliament has voted to support the Commission’s Action Plan on eHealth to 2020, which will be aimed at promoting and assisting in the roll-out of telemedicine, patients’ access to their health data and interoperability.
The Commission commented on the successfull vote, saying “improve healthcare for the benefit of patients, give patients more control of their care and bring down costs.”
The vote endorsed a report on the Plan prepared by Spanish Member of the European Parliament (MP) Pilar Ayuso, a member of the Parliament’s environment, public health and food safety (ENVI) committee. In her report, Ms Ayuso highlighted the potential for further growth in the eHealth market with the global telemedicine market expected to grow by an average of almost 19% reaching almost $30 billion within two years.
"In order for the public and healthcare professionals to have confidence in the benefits of eHealth applications, these must be given legal certainty, and issues including those of data protection, confidentiality, privacy and responsibility need to be resolved" said Ms. Ayuso.
Neelie Kroes, the European Commissioner for Digital Agenda, welcomed Ms Ayuso’s report and the MEPs’ vote. She particular applauded Parliament’s “insistence on the importance of interoperability of eHealth systems and the need for the Commission to take a leading role in establishing international standards and an EU eHealth Interoperability Framework.”
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Ken Clarke visits China to promote UK healthcare business
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Former Conservative health secretary Ken Clarke is travelling to China this week with a delegation of healthcare industry representatives as a means of promoting the UK healthcare industry within China.
The delegation is the largest ever group of its kind from the UK to visit China and consists of 50 people from 38 different companies. They will visit Beijing, Tianjin, Nanjing, Zhejiang and Shanghai over the course of the week and will oversee the signing of a number of government-to-government and business-to-business agreements, and the first meeting of a new China-UK Healthcare Working Group.
“The British healthcare system is the best in the world, and there will be important export opportunities as China invests huge sums of money in its healthcare system over the years ahead,” said Mr Clarke, speaking ahead of the delegation’s arrival in China.
“Healthcare and life sciences are among the strongest sectors of the British economy and our standards are held in high regard overseas. From building a hospital to training the staff to building the IT and management systems, the UK has the expertise that China needs as it builds a healthcare system that is projected to be spending a trillion dollars every year by 2020,” the Minister added.
With the Chinese economy set to continue its impressive growth theree are many investment opportunities for the UK government and healthcare industry to avail of in China.
Danish Pharma firm signs deal with GlaxoSmithKline
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In a deal that could be worth over £420 million, Danish pharmaceutical firm Santaris has formed an alliance with GlaxoSmithKline to develop new antiviral medicines. Santaris will receive £1.83 million up front as well as a £3 million investment from GSK into their product development. The rest of the money will depend on the success of any drug candidates in reaching the market and whether GSK opts to further develop and commercialise them.
The collaboration will allow GSK access to patented RNA antagonist compounds, based on Santaris Pharma's unique Locked Nucleic Acid technology, for development as potential new treatments for certain viral diseases.
Commenting on the collaboration Dr Henrik Ørum, Santaris Chief Scientific Officer and VP Business Development said "We are delighted that GlaxoSmithKline has chosen to collaborate with Santaris Pharma in the RNA medicines field. We are confident that the high potency and exquisite precision of RNA targeting achievable by LNA oligonucleotides has the potential to achieve clinical breakthroughs in viral infections. I can think of no stronger partner for Santaris Pharma in infectious disease research than GSK"
Dr Zhi Hong, Senior Vice President and Head of GlaxoSmithKline's ID CEDD said "The Locked Nucleic Acid technology platform developed by Santaris Pharma has the potential to transform Gene Interference therapies. We are facing numerous challenges in infectious disease areas where tractable targets are limiting. Innovative medicines with unprecedented mechanisms of action are lacking. This alliance has the ability to accelerate our drug discovery programmes against multiple infectious disease targets".
The deal is sure to be beneficial to both parties with Santaris potentially set for a very large injection of funds for future developments.
For more on this story see:
Artificial bone marrow developed in Germany
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Scientists at KIT, the Max Planck Institute for Intelligent Systems, Stuttgart, and Tübingen University in Germany have successfully developed a prototype for artificial bone marrow that mimics its natural partner and could be used for the treatment of leukemia in the future.
Current stem cell donor methods for treating leukemia are limited by the lack of appropriate transplants and so the researchers looked into developing an artificial bone marrow whereby the required hematopoietic cells could be produced in the laboratory and successfully applied to any patient.
The research team utilised synthetic polymers to create a porous structure that is similar to the sponge-like structure of the bone in the area of the blood where bone marrow is formed. Additionally, they added protein building blocks for the cells to anchor to. To ensure successful exchange of substances, the team also added other types of cells from the stem cell niche into the structure.
Then, the researchers introduced hematopoietic stem cells, (which supply immune cells to the blood) isolated from cord blood into the artificial bone marrow. The cells were then allowed to reproduce for a number of days, after which analyses showed that the cells really reproduce in the newly developed artificial bone marrow.
The research is still in its infancy and it will be another ten to fifteen years before a practical application of this method can be utilised in a clinical environment.
For more on this story see the World Pharma News website
Sanofi outlines its trial data sharing plan
The new joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing took effect on 1 January 2014 and Sanofi have been quick to outline their intentions for the sharing of data. The new principles from EFPIA, the European Federation of Pharmaceutical Industries and Associations. and the Pharmaceutical Research and Manufacturers of America (PhRMA) provide a framework for researchers to access patient-level data, clinical-trial protocols and clinical-study reports for new medicines approved in the US and the European Union after 1 January 2014.
Christopher Viehbacher, chief executive officer of Sanofi, and current president of EFPIA had this to say "Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow.”
Under the new principles companies are obliged to share data created only on or after the 1st of January 2014. Requests for access to clinical trial data will be judged by a panel of industry experts not connected with the company and will be accepted based on the scientific importance of the research being conducted as well as the qualifications and ability of the research team to successfully carry out the research using shared data.
Read more at: http://www.pharmatimes.com/Article/14-01-07/Sanofi_sets_out_trial_data-sharing_stall.aspx#ixzz2piomwby8
An apple a day really does keep the doctor away
Picture Source: www.healthcaredesignmagazine.com
We've all heard that age-old proverb "An apple a day keeps the doctor away". New research from the University of Oxford has shown that there's quite a lot of truth to the proverb with their studies indicating that vascular deaths could be cut dramatically if everyone over the age of 50 was prescribed an apple a day.
Of course the treatment of choice these days is statins with numerous trial results suggesting that statins can reduce the risk of vascular events, whether the patient has an underlying risk or not. As such, calls are being made for greater use of statins at a population level, particularly for people aged 50 years and over.
As part of their research they used mathematical models to predict the outcomes for people offered a statin a day or an apple a day. The statins produced the more favourable results as a daily dose to 17.6 million more adults would reduce the annual number of vascular deaths by 9,400, while offering a daily apple to 70% of the total UK population aged over 50 years (22 million people) would avert 8,500 vascular deaths. The research was published in the Christmas edition of the British Medical Journal.
So there you have it, an apple a day really does keep the doctor away. But of course the pharmaceutical industry can always improve on nature and increase the efficacy of natural medicines making them even more effective.
For more on this study see here.
GlaxoSmithKline overhauls sales practices
GlaxoSmithKline has responded to recent bad press by overhauling their sales practices, in a move widely welcomed by the industry. The new policy will esssential see GSK stop paying doctors for promoting its drugs and scrap prescription targets for its marketing staff. The move comes as a result of GSK's plans to avoid conflicts of interest that could put commercial interests ahead of the best outcome for patients.
Commenting on the announcement Fiona Godlee, editor of the British Medical Journal said "Where GSK leads we must hope that other companies will follow,"
GSK's Chief Executive Andrew Witty released a statement about the change stating that it was necessary to ensure that patients' interests always came first. "We recognize that we have an important role to play in providing doctors with information about our medicines, but this must be done clearly, transparently and without any perception of conflict of interest," he said.
The plan is to have the new procedures in place by 2016 when doctors will no longer be paid for speaking at medical conferences. Regarding the prescription targets, marketing staff will now be assesssed based on their overall performance as well as that of GSK as a whole.
It will be interesting to see if other companies change their policies in a similar fashion but at the end of the day it is the patient who stands to reap the most benefit from such actions.
For more on this story see here
AstraZeneca boosted by trial results for new gout treatment
AstraZeneca's (AZ) newest candidate treatment for gout, lesinurad has succeeded in a phase III trial and is scheduled to be filed next year. The LIGHT study used lesinurad to treat patients who are unable to be treated with xanthineoxidase inhibitors such as allopurinol and febuxostat.
Lesinurad is the lead compound in a new class of gout treatments called selective uric acid re-absorption inhibitors (SURIs), which increase uric acid excretion from the body, the buildup of which causes pain. AstraZeneca acquired the novel compound when it took over Ardea Biosciences last year.
In the Phase III trial, lesinurad performed better than a placebo and showed a significant reduction in the amount of uric acid production.
Gout is a very painful condition in which uric acid crystals are deposited into the joints of the body which brings pain similar to that experienced by arthritis sufferers. It affects almost 15 million people worldwide and is still a somewhat small market within the pharmaceutical industry however it is predicted to grow as new treatments come on to the market.
Univesity receives funding to reduce animal research in drug development
Picture Source: University of East Anglia
Rats and mice have long been a key tool in the study of toxicity when it comes to developing new drugs but new research aided by a £1.26 million funding boost is hoping to explore alternative methods in order to reduce the number of animals being tested on.
Researchers at the University of East Anglia in the UK received £90,000 from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) as part of a £1.26 million funding round. THe alternative methods being considered include mammallian cells, early frog embryos and computer modelling.
Dr Grant Wheeler from the UEA School of Biological Sciences will oversee the project. He said: "Drug toxicity is an important concern in the development of pharmaceuticals that are effective and safe for use in patients. Currently this requires the use of a large number of animals to ensure that new drugs are non-toxic and therefore safe to use in human clinical trials."According to the Home Office almost 80,000 rats and mice were used in studies on drug testing in 2012 alone. This is a huge number of animals, so any new protocols that can reduce this burden on animal testing could have a huge impact in significantly reducing the number of animals used for drug safety testing each year.
The sheer number of animals being tested on per year according to the figures released by the Home Office is quite staggering and any methods which could reduce this number could be of great benefit to the pharmaceutical industry from a cost perspective, but also to the animals themselves of course.
See more on this story here.
Johnson & Johnson expands UK partnering network
Johnson and Johnson (J&J) are expanding their network of life sciences innovation centres worldwide with the UK being the first to receive the new partnering offices.
Earlier this year J&J annoucned that they would be creating four innovation centres in London, San Francisco, Shanghai and Boston. The five new UK offices will act as satellites to the London hub with offices being opened in Cambridge, Oxford, Manchester, Edinburgh and Cardiff where life sciences are focused. The new innovation centres are designed to create closer links with academic researchers with the teams in the centres comprised of science and business experts who will work on identifying early stage innovation and support the translation of research into new products for patients.
"Each J&J innovation centre has local deal-making capabilities with the flexibility to adapt deal structures to match early-stage opportunities and establish novel collaborations that speed development of those innovations," said Dr Kurt Hertogs, incubator strategy leader for the London centre.
Following on from recent announcements by GlaxoSmithKline who are boosting their presence in the Pharmaceutical sector with the upgrading of their facilities, this comes as another positive sign that the UK is seen as a great source of innovation and research talent.
See more on this story on the PM Live site here.