Pharma Research Blog - Whitehall Training

  • Internet searches could find hidden ADRs

    It must be the goal of every pharmacovigilance system to make the capture of accurate and comprehensive ADR data as efficient as possible. Recently, schemes have made it easier for patients to report … more

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  • Investors apply pressure for full disclosure

    I have written about the All-Trials Initiative several times. It has many vocal supporters and equally vocal critics – especially in the US. I thought that with the recent EU legislation on full … more

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  • 10 percent of SUSARs miss FDA 15-day deadline

    A recent study shows that around 10% of serious and unexpected drug adverse reactions (SUSARs) miss the FDA’s mandatory 15-day reporting window. What seems even more alarming is that the … more

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  • Why is Japanese generic drug use so low?

    The Japanese health ministry wants generics to account for 80% of prescriptions in the country by 2017 – but the country has one of the lowest uses of generics. There is some general suspicion … more

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  • The risk-benefit equation that doesn’t balance

    At the end of June, the US Supreme court ruled that the EPA needs to consider the cost of implementing regulations to curb emissions from power plants.

    The problem is that one side of the … more

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  • Has China crossed an ethical red line?

    China’s recent biotech research has shocked many observers for apparently crossing ethical boundaries.

     

    China is investing massively in biomedical research. Earlier this year, … more

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  • MHRA makes record seizure of counterfeit medicines

    Today, the UK MHRA (Medicines and Healthcare products Regulatory Agency) announced biggest haul of counterfeit and unlicensed medicines in the agency’s history – almost double its total … more

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  • Greece runs up £1 billion drug debts

    It’s a well-worn principle. When the poorest in society need healthcare, it falls on the state to meet their needs – to some extent at least.  But what when we are talking about the … more

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  • Cake and death to raise the profile of biobanking

    This week, the University of Bradford has been holding a series of “Death Cafés” with sessions on subjects ranging from how to donate organs and tissue to biobanks to how to plan … more

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  • The problem and the solution?

    Cuba is famous for several things – Fidel Castro, communism, Guantanamo Bay, rum and cigars... The latter have been enjoyed by moneyed smokers the world over – albeit covertly in the US. … more

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  • EudraVigilance drug AEs fall by 17% in 2014

    The number of links between drugs and adverse events identified by the European Medicines Agency fell by 17% in 2014. However, the EMA does not believe that the drop is a sign of an inherent increase … more

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  • Case highlights the vital role of tissue tracking

    A recent case in Milwaukee has highlighted the vital importance of accurate and effective real-time tissue tracking.

     

    The tissue in this case was destined for the treatment of a 25-year … more

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  • Sexism and Good Clinical Practice

    According to Tamarra James-Todd, an epidemiologist at Harvard Medical School, female subjects have historically been excluded from toxicology or biomedical research.

     

    Even when women are … more

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  • UK Meningitis B vaccine decision stirs emotions

    The UK is soon to become the first nation routinely to immunize babies against Meningitis B. However, the decision took over a year from the Department of Health being recommended that Bexsero MenB … more

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  • Novartis accused of trying to block UK wet AMD trials

    The British Medical Journal has alleged that Novartis has been using some shady practices to hinder trials comparing Lucentis and Avastin for wet age-related macular degeneration. 

    For many … more

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  • Reduce-Reuse-Recycle comes to clinical trials

    Making the best use of scarce resources makes sense in all areas of life – none more so than in the vastly expensive world of pharmaceutical development.  A trial at University College … more

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  • US FDA publishes electronic informed consent Q&A

    Informed consent is much more than just getting a signature on a form. Whilst the ICF (Informed Consent Form) still plays a vital role, it is only part of an increasingly diverse picture. Recently … more

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  • New blood test could predict severe ADRs

    A study at Imperial College, London is examining the use of stem cells to help predict cytokine storms in first human trial participants.

    Back in 2006, the papers were full of stories and horrific … more

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  • A blind dog walks into a bar...

    A study at the University of Arizona is investigating whether pet dogs may help cultivate probiotics in their owners.  My first thoughts were around how you’d study this whilst following … more

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  • iPhone medical research app raises GCP questions

    “Now everybody can do their part to advance medical research.”  This is the up-beat message emblazoned across the webpage Apple uses to promote its new ResearchKit app. An application … more

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  • Informed consent vs the Sun orbiting the Earth

    A recent viral video shows Saudi cleric, Sheik Bandar al-Khaibari, explaining in some detail why the Sun clearly revolves around a stationary Earth.  Indeed, he claims that air travel would not … more

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  • IT security and big pharma

    "As a global pharmaceutical company, our systems are subject to frequent attacks."

     

    The quote above caught my eye and comes from the risk factor section of Pfizer’s US Securities and … more

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  • Pharma advertising complaints down in 2014

    The MHRA’s report, Delivering high standards in medicines advertising, was published yesterday and reveals a fall in complaints received last year. In 2014, it received 193 complaints, down from … more

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  • No news is good news – except in clinical research

    The press agencies like nothing more than bad news – disaster sells. But the opposite seems true in clinical research, according to a recent paper in JAMA (Journal of the American Medical … more

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  • Letting the genie out of the bottle?

    Earlier this week, the UK House of Commons voted in favour of allowing the use of DNA from a third person in IVF to help eliminate mitochondrial disease. This was hailed as a major development … more

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  • What if universities were fined for retractions?

    Retraction Watch (the body that monitors academic retractions and criticism) has posed an interesting ethical question – if researchers are found to have falsified data in publicly-funded … more

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  • Hanging on by their fingertips...

    Yesterday I heard the news that two climbers had become the first to successfully free-climb a sheer 3,000 ft rockface in Yosemite National Park – for some reason this leapt to the forefront of … more

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  • First six drugs chosen for EMA fast track programme

    The European Medicines Agency (EMA) has selected the first six drugs for its fast-track “adaptive pathways” pilot programme.

     

    The adaptive pathways programme was announced in March … more

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  • An eventful week for oncologic manufacturers

    This has been an interesting week for manufacturers of oncology drugs. On Wednesday, the US FDA’s ODAC (Oncologic Drugs Advisory Committee) unanimously recommended approval for the … more

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