エクソンスキッピング薬巡るFDA文書に見る米国のすごさ【日経バイオテクONLINE Vol.2551】
from 日経バイオテクONLINE
(2016-10-28 8:00)
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私が担当しているコラム「谷本佐理名の“FDAウォッチ”」でも取り上げましたが、米国で迅速承認された筋ジストロフィーに対するエキソンスキッピングの治療薬eteplirsenですが、承認の直前まで臨床試験で得られたエビデンスをどう評価するかを巡り、米食品医薬品局(FDA)内で対立が起きていたことが明らかになりました。
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Chimps and bonobos interbred and exchanged genes
from New Scientist - News
(2016-10-28 3:00)
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Humans are not the only great apes to have had an ancient fling with related species. New evidence shows that chimps carry genes from bonobos
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Male contraceptive injection works? but side effects halt trial
from New Scientist - News
(2016-10-28 3:00)
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The injection was effective in nearly 96 per cent of couples, but researchers have voiced concerns over?side effects including depression, muscle pain, acne and increased libido
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Male contraceptive pill works? but side effects halt trial
from New Scientist - News
(2016-10-28 3:00)
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The injection was effective in nearly 96 per cent of couples, but researchers have voiced concerns over?side effects including depression, muscle pain, acne and increased libido
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Brown pebble turns out to be first ever pickled dinosaur brain
from New Scientist - News
(2016-10-28 2:01)
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The petrified specimen comes from a large plant eater such as Iguanodon, which lived about 133 million years ago, and whose brain was pickled in mud after it died
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Bump hiding in 20-year-old data could be undiscovered particle
from New Scientist - News
(2016-10-28 1:24)
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After re-analysing millions of particle decays in an old physics experiment, one physicist has found a tantalising bump that could signal a new particle
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Swifts break record by staying aloft for 10 months at a time
from New Scientist - News
(2016-10-28 1:00)
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Common swifts probably sleep and mate on the wing, and juvenile birds may fly even longer than adults? perhaps for two years non-stop
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UK must face reality on climate impact of new Heathrow runway
from New Scientist - News
(2016-10-28 0:57)
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We can’t pretend that emissions from aircraft are somebody else’s problem, says climate and energy expert Richard Black
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NZ発のDupont社ビフィズス菌の機能性表示食品の第1号はヤツレン
from 日経バイオテクONLINE
(2016-10-28 0:15)
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米Dupont社が事業化しているビフィズス菌HN019株(Bifidobacterium lactis HN019)の機能性表示食品の届け出が受理された。消費者庁が2016年10月27日夕方に公表した。
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厚労省、複数ウイルスへの抗原特異的T細胞療法など、2件の適合を確認
from 日経バイオテクONLINE
(2016-10-28 0:10)
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厚生労働省は、2016年10月27日、第14回厚生科学審議会再生医療等評価部会を開催し、名古屋大学医学部附属病院と東京医科歯科大学医学部附属病院から提出されていた2件の第1種再生医療等提供計画について、再生医療等提供基準に適合していると確認した。いずれも臨床研究として実施される。
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