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医療用医薬品・医療機器産業の経営層向けニュース

In Vivo(インビボ)は主に「成長」「イノベーション」「リーダーシップ」「マーケットアクセス」「マーケットインテリジェンス」の5つの観点から世界の医療用医薬品産業のトレンドを取材しています。

世界の開発パイプラインを分析したインフォーマ・ファーマインテリジェンス発行のレポート「Pharma R&D Annual Review 2018」によると、日本は創薬能力では世界第2位、市場規模でも3位につけています。欧米の新薬創出国と比較して劣っているわけではありません。

一方で世界の大手医薬品企業の経営幹部は、激しい国際競争を勝ち抜くために最新情報を常に把握し、戦略的思考で成長の機会をうかがっています。

In Vivoを読むことによって、経営に携わる人々は根拠をもって意思決定をし、リスクをコントロールできるようになります。In Vivoは今日の経営層または新規ビジネス開発担当者にとっては必須のビジネスツールです。

経営戦略・トップマネジメントの視点から研究開発や財務戦略なども含む医薬品産業ニュースを読めるのはIn Vivoだけです。特集記事、注目の人物、KOLの独占インタビュー、業界幹部の異動情報なども充実しています。

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無料の最新記事&レポート

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    A Visual Guide To US FDA's Evolutionary Decade In Review

    16 Jan 2020

    An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

    Topic fda policy-and-regulation

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    EU 2019 Approvals: Novel Therapies Make Strong Showing

    15 Jan 2020

    Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019. 

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Sharfstein: US FDA Incentives Not Broke, But Fix Them

    15 Jan 2020

    The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines

    By Sue Sutter 08 Jan 2020

    Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    US FDA Approval Of Lynparza For Pancreatic Cancer Opens Door For PFS Endpoint In Disease

    08 Jan 2020

    US_FDA_Approval_Of_Lynparza_1

    AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

    Topic cancer clinical-trials

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Mylan/Biocon's Insulin Glargine Would Get A Respite Under US Budget Legislation

    By Cathy Kelly 18 Dec 2019

    Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Rising's Generic Price Fixing Settlement Follows Bankruptcy, Cooperation With DOJ

    06 Dec 2019

    Rising Pharmaceuticals agrees to pay $3.1m, admits to conspiring to fix prices for hypertension drug, and enters into deferred prosecution agreement. Pfizer asks court to be removed from complaint by state AGs.

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Former FDA Commissioner Frank Young Passes Away At 88

    By Michael Cipriano 28 Nov 2019

    From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    How Sustainable Is England's Cancer Drugs Fund?

    By Francesca Bruce 20 Nov 2019

    The Cancer Drugs Fund has improved access to oncology drugs, but if it is to remain fit for purpose it will need to evolve.

    Topic cancer

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Zolgensma Data Integrity Fallout

    20 Nov 2019

    Zolgensma Data Integrity Fallout

    Novartis finds itself facing possible criminal or civil action for admitted data manipulation on its application for Zolgensma, a gene therapy used to treat children with spinal muscular atrophy (SMA) – manipulation disclosed only after FDA approval. Pink Sheet was the first to report on the drug’s loss of EU accelerated assessment, nearly 3 weeks before the pharma giant admitted to submitting falsified data to FDA. Follow the scandal and anticipate its implications on the industry with Pink Sheet’s coverage and timeline.

    Topic cell-and-gene-therapy fda

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Amarin's Vascepa: US FDA Panel To Scrutinize Breadth Of CV Risk Reduction

    13 Nov 2019

    REDUCE-IT enrolled a higher risk group than the broad population targeted by Amarin’s proposed indication statement, agency says; although reviewers conclude an interaction between the mineral oil placebo and statins cannot be excluded, any impact would have been small and unlikely to change overall treatment effect.

    Topic drug-review fda

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

    By Mandy Jackson 08 Nov 2019

    Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

    Topic infectious-diseases

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Webinar: FDA and its Commissioners

    By nielsen-hobbs 05 Nov 2019

    The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

    Topic fda

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Twirla Gets Strong Advisory Cmte. Endorsement Even After USA FDA Pans Application

    05 Nov 2019

    The Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1, with one abstention, in favor of approving Agile's transdermal contraceptive patch Twirla in a sharp divergence from the US FDA's negative evaluation of the drug, though it remains an open question of how the agency will ultimately come down.

    Topic drug-review fda

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Pink Sheet Sample Article Pack: The Hottest Topics in Pharma Regulatory Compliance

    16 Oct 2019

    Pink Sheet Sample Article Pack: The Hottest Topics in Pharma Regulatory Compliance

    When you look at newly approved drugs, the latest product reviews and the decisions made during the process, you can gain critical insights to inform your own strategic decisions. That’s what Pink Sheet delivers, and now you can try it for free.

    Topic Drug approval Drug development landscape

医薬品産業専門のジャーナリスト&アナリスト

Editor

William Looney

Editor, Executive Editor, In Vivo

USA

William Looney

William specializes in

  • Biopharma pipeline strategy
  • Biotech
  • Commercial Strategy
  • Market Access
  • Policy and Regulation

+40 year(s) experience

Editor

Cathy Kelly

Editor, Senior editor

Washington DC, USA

Cathy Kelly
Management

Denise Peterson

Management, Editor In Chief, Pharma US

Washington DC, USA

Denise Peterson

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