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Pharmalot, Pharmalittle: Duchenne Drug Nixed in US Available in the UK

By Beenthere2Hippie, Jul 9, 2016 | |
  1. Beenthere2Hippie
    And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. And our agenda is rather modest. We plan to spend time with two of our short people and escort Mrs. Pharmalot to a festive gathering. And what about you? Summer is in full swing, so perhaps this calls for a jaunt to the shore or a lake. You could use the time to exercise outdoors or simply catch up on chores. That rhymes. Well, whatever you do, have a grand time, but be safe. Enjoy and see you soon …

    The National Health Service in England agreed to cover a Duchenne muscular dystrophy drug made by PTC Therapeutics, PharmaTimes says. The deal includes an outcomes-based incentive for the company, as well as a mechanism to monitor how well the medicine has actually worked before future funding decisions are made. The application for the same drug, which costs about $288,000 a year, was rejected earlier this year by US regulators.

    Meanwhile, Eisai is considering possible legal action to fight delays in the UK health care system that prevent patients from accessing one of its drugs to treat a rare form of cancer, Reuters tells us. Its Lenvima treats a form of thyroid cancer and was approved by the European Commission in May 2015, but will not receive a recommendation from the UK’s National Institute for Health and Care Excellence until at least April 2017.

    Juno Therapeutics halted a clinical trial of its lead immunotherapy treatment after three patient deaths, STAT reports. Shares in the company, which is pursuing an approach called CAR-T immunotherapy, dived 30 percent in after-hours trading Thursday. Juno blamed the deaths on a recent decision to add the chemotherapy fludarabine to the mix of drugs used to treat patients before administering their own JCAR015 compound.

    The pharmaceutical industry and government officials created a task force to review regulatory and other issues following the UK’s decision to leave the European Union, Reuters writes. Drug makers account for 25 percent of UK business research spending and worry about drug approval delays. The task force will be chaired by GlaxoSmithKline chief executive Andrew Witty, AstraZeneca chief executive Pascal Soriot, and life science minister George Freeman.

    The US Centers for Medicare and Medicaid Services banned Theranos founder Elizabeth Holmes from operating a blood-testing laboratory for at least two years and pulled regulatory approval for its California lab, the Wall Street Journal informs us. The sanctions include an unspecified monetary penalty.

    The Council of the European Union disclosed a plan to analyze the pharmaceuticals markets in Europe in hopes of improving patient access to medicines.

    BioMarin Pharmaceutical shares jumped 9 percent Thursday on speculation that Roche is preparing a takeover offer, according to CNBC. The Drugs Controller General of India has again found Sanofi’s popular painkiller drug, Combiflam, to be of sub-standard quality in its latest test, the Business Standard writes.

    Ablynx’s hopes for a potential blockbuster were boosted Thursday by strong clinical trial results in rheumatoid arthritis, vindicating a $175 million bet placed on the product by AbbVie, Reuters says. Lupin received an inspection report from the US Food and Drug Administration for its Goa facility and a review remains underway, the Economic Times reports.



    By Ed Silverman - STAT/July 8, 2016
    https://www.statnews.com/pharmalot/2016/07/08/duchenne-ptc-therapeutics-eisai-juno/
    Art: Alex Hogan
    Newshawk Crew

    About Author

    Beenthere2Hippie
    BT2H is a retired news editor and writer from the NYC area who, for health reasons, retired to a southern US state early, and where BT2H continues to write and to post drug-related news to DF.

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