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  • 4-Oct-18
    Celyad Announces Exclusive Agreement for Horizon Discovery’s shRNA Platform to Develop Next-Generation Allogeneic CAR-T Therapies

    Celyad to Present CYAD-01 Solid Tumor Clinical Updates and Pre-Clinical Pipeline Data at the 2018 SITC Annual Meeting
    The co-expression of a single shRNA targeting MICA and MICB with a NKG2D CAR (CYAD-01) generates CAR-T cells resistant to target driven fratricide and improves CYAD-01 cell persistence in vivo
    Date & Time: November 9, 12:45 – 2:15 p.m. and 6:30 – 8 p.m.

  • 2018/10/01 06:36

    BioSpace
    Just-Announced U.S. and Cuba Biopharma Venture Sees Fruit in Lung Cancer Study
    Published: Sep 27, 2018
    A three-year-old cancer research alliance between U.S. and Cuban scientists is bearing fruit. A Cuban-developed lung cancer treatment combined with Bristol-Myers Squibb’s anti-PDL1 Opdivo shows promise in treating patients who would not likely benefit from immune checkpoint inhibition

  • 2018/09/14 06:49

    SeekingAlpha
    Bristol-Myers Squibb Company (BMY) CEO Giovanni Caforio Presents at Morgan Stanley 16th Annual Global Healthcare Conference (Transcript)
    Sep. 13, 2018 3:24 PM

  • 2018/09/06 22:56

    NASH
    SeekingAlpha 9/6/2018
    •BMS-986036, a pegylated human fibroblast growth factor-21 analogue, is an investigative metabolism modulator drug candidate in mid-stage clinical trials for NASH fibrosis and cirrhosis.
    •FGF21 is prevalent in metabolically active tissues, liver, pancreas, and adipose tissue, where it positively regulates glucose and lipid metabolism.
    •BMS-986036 could be a likely source for new organic growth in future years given its promising preliminary data for NASH, a heterogeneous disease with an addressable market of >$30B.
    •NASH is a progressive chronic liver disease without therapeutic options that have been projected to surpass HCV infection as the leading cause of liver transplant in the US beginning in 2020.

  • カイプロリス
    FiercePharma 8/31/2018
    Can Amgen's new-and-improved Kyprolis kick-start myeloma sales?

  • 試験と実治療比較:患者年齢分布
    NSCLCに注目
    75歳以上対象外、キイトルーダの抜群の成績と関連ありか?
    Aero Data Lab
    Populations in Anti-PD1 Immunotherapy Trials vs. Real World Patients
    Added: August 26, 2018

  • 事実を知らせるメディア:
    国際医薬品情報‏ @IPI_editors · 2時間
    国際医薬品情報さんがモトリオンをリツイートしました
    オプジーボの薬価引き下げについては、
    主たる効能・効果に係る用法・用量に変更があったため、
    変更前後の「1日薬価が同じ」となるよう、
    再算定(用法用量変化再算定)を行っていますので、
    「フラット」とみています。

    クールな個人:
    モトリオン‏ @motorion
    薬価引下げの影響はほとんどないと思うけど。むしろプラスかも。

    後付けで理由こじつけしかできないメディア:
    <東証>小野薬が続落 オプジーボの価格引き下げを嫌気:日本経済新聞

    とにかくオプジーボを蹴落としたい、自称アナ●●●:
    山田創‏ @So_Yamada_ · 8月22日
    小野薬品オプジーボ100mgバイアル当たりの単価が2014年から2018年の4年間で約4分の1まで下がる。けっこう、けっこうエグい。

  • 国際医薬品情報‏
    オプジーボ薬価、37.5%引き下げへ。11月1日から。中医協。主たる適応(肺がん)に対し体重換算用量から固定用量(240㎎)への変更(8月21日承認)に伴い「用法用量変化再算定」を適用し、20㎎1瓶5万7225円→3万5766円、100㎎1瓶27万8029円→17万3768円。なお、240㎎1瓶が11月に薬価収載される見通し。

  • fuj***** さん

    日本医師会
    www.okinawa.med.or.jp/html/kaigo_iryo/.../h280326-1i.pdf
    53ページ
    別表8
    用法用量変化再算定の計算方法

  • Bristol-Myers to sell Opdivo in China at half the U.S. price
    Aug. 21, 2018 1:30 PM SA News Editor

  • 小細胞肺癌
    市場はニッチだが、朗報
    EndpointsNews
    トップの座への競り合いは続いている
    they(BMSvsMerck) are still fighting for every edge they can get looking for a comeback to the top spot.

    BMS PRより
    肺癌の約10%〜15%を占める
    厄介な疾患であり、進行するまで症状はしばしば検出されない
    今年米国で診断された患者は2万7000人。広範囲に播種した、またはIV期の5年生存率は約2%である

    *SCLCは診断時までに広範囲に播種する傾向が強いため、治癒の達成は困難
    *治療ガイドライン制定以降20年間予後不良と生存率は改善されていない

    ファーストライン治療も進行中
    現在SCLC患者を対象として、ニボルマブ単剤療法、ニボルマブとイピリムマブの併用療法、プラセボ対照の3群を比較するフェーズ3のCheckMate 451試験が進行中である。
    Estimated Primary Completion Date : September 20, 2018
    9月20日読出し予定

    がんナビ
    2017/6/7
    進行小細胞肺癌にニボルマブ単剤、ニボルマブ+イピリムマブで持続的な奏効【ASCO2017】

    がん情報サイト
    cancerinfo.tri-kobe.org > ... > がん情報要約 > 治療(成人

  • Celyadテンバガー候補

    Par Virgil Meyre | investir.fr | Le 14/08/18
    遺伝子治療におけるCelyadの可能性は非常に大きい
    Celyadは、最近、財務と経営を強化した
    FDAの治験許可を取得。Celyadは再びテンバガーを見込める
    les perspectives de la biotech sont une nouvelle fois décuplées.

    L’autorisation de la FDA (Food & Drug Administration), l’autorité sanitaire américaine, de lancer le premier programme clinique allogénique ne faisant pas appel à de l’édition du génome (Cyad 101), vient s’ajouter à une série de bonnes nouvelles. Grâce à sa récente levée de fonds ainsi qu’à la signature de plusieurs partenariats, la capacité financière de Celyad s’est renforcée. Le groupe a par ailleurs consolidé sa direction avec l’arrivée du docteur Margo Roberts, ex-directrice scientifique de Kite Pharma, au conseil d’administration, et celle de Filippo Petit de la banque Wells Fargo au poste de directeur financier.

    *経営財務だけではなく、開発、上市の人材も強化している

  • 2018/08/15 07:29

    EPVantage August 14, 2018
    Most valuable unpartnered assets reveal a changing of the guard
    Annual analysis shows a new crop of biotech assets with ballooning valuations and no major partners.

    2017.10.12小野提携
    米国カリオファーム社とXPO1阻害剤「Selinexor」および第二世代XPO1阻害剤
    オンコロ 2017.03.04 
    多発性骨髄腫の新薬Selinexor(KPT-330)の治験を受ける前に知っておきたい7つのこと

  • Aug. 14, 2018 /PRNewswire/ --
    Array BioPharma Inc. today reported results for its fourth quarter and full year of fiscal 2018 and provided an update on the progress of its key commercial products and clinical development programs.
    Array is developing binimetinib in combination with PD-1/PD-L1 checkpoint inhibitors and previously announced separate, strategic collaborations with Bristol-Myers Squibb, Merck and Pfizer.
    Each collaboration is pursuing a different rationally designed clinical approach.
    Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea
    Japan's Pharmaceuticals and Medical Devices Agency has accepted the Manufacturing and Marketing Approval applications submitted by Ono Pharmaceutical Co, Ltd.

  • 補足
    EPVantage August 10, 2018
    Another study, Bristol’s Checkmate-451, focuses on first-line maintenance.
    ファーストライン治療はCheckmate-451試験中

    NCT02538666
    Last Update Posted : August 1, 2018
    Estimated Primary Completion Date : September 20, 2018
    9月20日読出し予定

  • カナダの小さな州:Prince Edward Island でも
    Melanoma Network‏
    Amazing news. Opdivo listed in PEI as August 1st - Q4W is available as well
    •Opdivo is being added for the treatment of unresectable or metastatic melanoma BRAF wild-type melanoma; advanced or metastatic non-small cell lung cancer; advanced or metastatic renal cell carcinoma.

  • Opdivo+Cabiralizumab:膵がん

    Five Prime Therapeutics Announces Second Quarter 2018 Financial Results
    • Cabiralizumab continues to advance in randomized Phase 2 trial in pancreatic cancer
    August 08, 2018 04:05 PM Eastern Daylight Time
    We are pleased with the progress across our pipeline, including BMS’s ongoing randomized Phase 2 clinical trial to evaluate cabiralizumab and OPDIVO® with and without chemotherapy as a second-line treatment in patients with advanced pancreatic cancer,” said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. Additionally, we are pleased that the first clinical candidate from our immuno-oncology research collaboration with BMS, the TIM-3 antibody BMS-986258, is now in a Phase 1/2 trial investigating it as a single agent and in combination with OPDIVO. FPA150, our first-in-class B7-H4 antibody, is receiving strong interest from investigators and is progressing well in the Phase 1 trial.”

  • Jack Allen‏ ツイート
    The effectiveness of blood Tumor Mutational Burden (bTMB) may play a key role in $BMY strategy for their IO portfolio (Opdivo/Yervoy) moving forward

    BMS:TMBバイオマーカーFoundation Medicineの研究(ロシュ)
    nature medicine 8/6/2018
    Foundation Medicine
    Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab

  • Breakthrough Therapy指定:
    エンコラフェニブ(ONO-7702)+ビニメチニブ(ONO-7703)

    Aug. 7, 2018 /PRNewswire/
    Array BioPharma today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI™), in combination with binimetinib (MEKTOVI®) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease.
    BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation,
    and currently there are
    <no therapies specifically approved for this high unmet need population.>

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