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nobleonetoo 18 posts  |  Last Activity: Aug 30, 2014 8:53 PM Member since: Dec 23, 2009
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  • I am from England and I found this latest news exciting and very hopeful for a lot of sick people.
    Ebola vaccine trials fast-tracked by international consortium
    28 August 2014

    Unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine

    A candidate Ebola vaccine could be given to healthy volunteers in the UK, The Gambia and Mali as early as September, as part of a series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in west Africa.

    Human trials of this candidate vaccine, being co-developed by the US National Institutes of Health (NIH) and GlaxoSmithKline, are to be accelerated with funding from an international consortium in response to the Ebola epidemic, which the World Health Organization recently declared a public health emergency of international concern.

    A £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID) will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the USA run by the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).

    The phase 1 trials will begin as soon as they receive ethical and regulatory approvals, which will be considered on an expedited basis. If approvals are granted, the UK research teams could start vaccinating volunteers from mid-September.

    The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities.

    The candidate vaccine is against the Zaire species of Ebola, which is the one circulating in west Africa, and uses a single Ebola virus protein to generate an immune response. As it does not contain infectious virus material, it cannot cause a person who is vaccinated to become infected with Ebola. Pre-clinical research by the NIH and Okairos, a biotechnology company acquired last year by GSK, has indicated that it provides promising protection in non-human primates exposed to Ebola without significant adverse effects.

    Safety trials with small groups of healthy volunteers are now required to ensure that the vaccine does not cause unforeseen side effects, and that it generates a good immune response to Ebola in humans, before it can be rolled out to larger at-risk populations, even on an experimental basis.

    To accelerate these trials, the NIH has generously agreed to provide the NIAID/GSK Ebola vaccine for safety studies led by the Oxford team, which will run in parallel to its own trials. Oxford’s Jenner Institute has extensive experience of clinical trials of similar vaccines, which they have evaluated clinically for six other diseases in Europe and Africa.

    If the first volunteers vaccinated in the Oxford study show a good response with no adverse reactions, the trial will, after approval from the relevant authorities, be extended to volunteers at the MRC Unit in The Gambia. A second West African arm of the study, led by Professor Myron M Levine of the Center for Vaccine Development at the University of Maryland School of Medicine, and Professor Samba Sow of the Center for Vaccine Development in Mali (a joint initiative between the University of Maryland School of Medicine and the Ministry of Health of Mali), will then begin in Bamako, Mali.

    The Oxford study will involve 60 healthy volunteers, while those in The Gambia and Mali will each involve 40. Each set of volunteers will be split into groups of 20 that will receive different doses of the vaccine so researchers can evaluate the best dose to use in terms of both safety and activity.

    NIAID are testing this same vaccine in the USA, in addition to a related vaccine that is designed to protect against two Ebola species (Ebola Zaire and Ebola Sudan).

    This collaborative multi-trial approach will help ensure the fastest possible progress to determining the best candidate vaccine approach and delivery. The addition of west African arms will also ensure that the studies take account of differences between European and west African populations that might affect safety or immune response.

    It is hoped that the phase 1 trials might be finished by the end of 2014, after which deployment of the vaccine could be fast-tracked should it prove to be safe and immunogenic.

    Dr Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK said: “Today’s announcement shows how private and public partners can pull together to respond to this critical public health emergency. Developing a new vaccine is complex with no guarantees of success and it’s still early days for our Ebola vaccine candidate. But we are encouraged by progress so far and will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to the control of this or future Ebola outbreaks.”

    Sentiment: Hold

  • I believe this to be a big news item.

    I am from England and it has just been announced Glaxo Smith Kline who also has an interest in Acadia, has submitted and will senk more of a new 'hopeful' help and/or cure for he horrendous Ebola outbreak. They were already testing a vaccine and it had not fully passed all the required testing with the British Medical Assoc. but as this is a frightening and so dangerous an outbreak - they are going to use the vaccines.
    One of the biggest pharmaceutical firms in the British Isles and beyond. I saw this on the BBC news yesterday Less

    Sentiment: Hold

  • On July 31, 2014, MannKind Corporation ("MannKind") and Amphastar France Pharmaceuticals S.A.S., a French corporation ("Amphastar"), entered into a Supply Agreement, pursuant to which Amphastar will manufacture for and supply to MannKind certain quantities of recombinant human insulin ("Insulin") for use in MannKind's product AFREZZA�. Under the terms of the Supply Agreement, Amphastar will be responsible for manufacturing the Insulin in accordance with MannKind's specifications and agreed-upon quality standards. MannKind has agreed to purchase annual minimum quantities of Insulin under the Supply Agreement of an aggregate of approximately �120.1 million in calendar years 2015 through 2019. MannKind may request to purchase additional quantities of Insulin over such annual minimum quantities.

  • Tomorrow should be interesting

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  • Reply to

    BRK Up, was there a div announcement?

    by alysheba1 Aug 4, 2014 3:24 PM
    nobleonetoo@att.net nobleonetoo Aug 4, 2014 4:05 PM Flag

    Just a 'little' discussion on the TRILLION dollar value attributed to Warren and his investments!

    Sentiment: Hold

  • nobleonetoo@att.net nobleonetoo Jul 29, 2014 3:47 PM Flag

    That is the WHOLE POINT! He knows nothing but never the less runs his mouth and says NOTHING!

  • nobleonetoo@att.net nobleonetoo Jul 29, 2014 3:45 PM Flag

    Another pathetic person seeking his 'few minutes of fame' The Company will make news known when and if
    they are ready and sure of what they are going to announce!

  • MannKind Corporation stock got a jolt in early trading today from hedge fund Tourbillion Capital Partners, which told clients that it expects the company’s stock to fall 90% because its new drug for diabetes is over-hyped.

  • http://seekingalpha.com/article/2343745-mannkind-why-the-short-argument-is-shortsighted

  • nobleonetoo@att.net by nobleonetoo Jul 25, 2014 2:01 AM Flag

    ACAD or the new Diabetes oral medication MKND ??? BOTH serve as a wonderful help to patients in either medical predicament!

  • The road to approval has been a tough one for MannKind. The product was developed in the shadow of Pfizer Inc's failed inhaled insulin Exubera, which was approved in 2006 and expected to generate annual sales of $2 billion. But the inhaler was big and bulky and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn.

    That failure, together with concerns the inhaled powder could increase the risk of lung cancer, has led to considerable investor skepticism about Afrezza's future.

  • nobleonetoo@att.net nobleonetoo Jul 7, 2014 8:55 PM Flag

    There is NO news! The imagination of some people gives them a personal 'high' Ignore most of the messages and wait until the Company has some real statements to make!

    Sentiment: Hold

  • Reply to

    I Just Spoke With The Company !

    by kevinmik Jul 2, 2014 4:18 PM
    nobleonetoo@att.net nobleonetoo Jul 2, 2014 4:40 PM Flag

    kevin - wants to be known as an 'insider' gleaning information possibly the Company is even not sure will happen now or in the future! Hate to personally see the price falling back but until the CEO decides to make information available to all investors - will have to wait and hope for the best like everyone else!

    Sentiment: Hold

  • nobleonetoo@att.net nobleonetoo Jul 1, 2014 2:54 PM Flag

    Actually statement was 5.3 billion in debt! Have you seen how long this Company has been 'trying'?

  • Have to wonder if the CEO was there pushing the Company in order to boost the companies financial venue. They are in debt over 5 billion and volume today pushed greatly by the FOX interview has really boosted the 'coffers' I do hope the diabetes help claims are true. I have the disease and help would be greatly appreciated! L

    Sentiment: Hold

  • Have to wonder if the CEO was there pushing the Company in order to boost the companies financial venue. They are in debt over 5 billion and volume today pushed greatly by the FOX interview has really boosted the 'coffers' I do hope the diabetes help claims are true. I have the disease and help would be greatly appreciated!

    Sentiment: Hold

  • Old 'positive' news and the testing a year older now - we need new positive results NOW!
    Come back when you research updated 'positive' reports.

    Sentiment: Hold

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