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世界の薬事規制と承認審査に関するニュースサービス

世界的に新薬の開発競争が激しさを増す中、売上の最大化やドラッグ・ラグ解消の必要性から、海外との同時申請や国際共同治験も増えています。特に薬価の抑制政策やジェネリック医薬品の普及などにより、国内新薬市場の伸び悩みが予想される日本の医薬品企業や医療機器メーカーにとって、海外の薬事規制や承認審査制度について知悉することはとても大切です。

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長年、世界のレギュラトリー・アフェアーズをみているジャーナリスト＆アナリストチームが、薬事規制がビジネスに及ぼす影響について独自の考察を交えて記事を執筆しています。

Pink Sheetの購読ページでは、ログインしなくても各ニュースの冒頭を読むことができます。また、姉妹サービスのScrip(スクリプ)では、世界中の医療用医薬品と製薬産業全般に関する包括的なニュースを配信しています。あわせて購読されるとより効果的です。
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ニュースや記事の内容またはデータや分析に関してご質問がございましたらお気軽にご連絡ください。ジャーナリストまたはアナリストがお答えします。

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

    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.

    article

  • 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

    article

  • 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

    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

    report

  • 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

    analysis

  • 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

    View article

  • 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

    Full video

  • 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

    article

  • 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

    View article

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

    16 Oct 2019

    Pink Sheet Performance Trackers: Navigate a complex world with the regulatory performance trackers from Pink Sheet

    Keep track of compliance, legislation, policy regulations, and industry developments with the expertise of our worldwide network of expert analysts and journalists on the ground in key global regions.

    Topic drug-development-landscape drug-review fda

    View article

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    The Opioids Crisis Regulatory Response to an Epidemic

    14 Oct 2019

    The Opioids Crisis Regulatory Response to an Epidemic

    With the opioid crisis in full swing in the US, government and regulatory agencies are announcing changes to guidance and legislation related to both new and existing drugs. Keep abreast of these critical changes with essential coverage from Pink Sheet.  

    Topic Drug approval FDA

    article

  • Scrip: 世界の医療用医薬品＆製薬産業に関するニュース, Pink Sheet: 世界の薬事規制と承認審査に関するニ...

    Mega Mergers

    30 Sep 2019

    Mega Mergers

    When it comes to M&A, Informa Pharma Insights has got it covered. Our readers benefit from exclusive executive interviews with industry leaders and expert analysts on business, pipeline and M&A strategy, broad and detailed coverage on implications of deal-making from antitrust to quality compliance, commercial and R&D infrastructure, regional repercussions and the impact on existing partners. 2019 has already been notable for major deals, from the closing of the $62bn Takeda/Shire acquisition to the agreed purchases of Celgene for $74bn by Bristol-Myers Squibb and of Allergan for $63bn by AbbVie, to Pfizer’s plan to merge its Upjohn generics business with Mylan.

    Topic business-strategies

    article

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Clinical Trial Design Report

    26 Sep 2019

    Rising costs, patient recruitment issues, shifting regulations, and more are making bringing new drugs to market more difficult than ever. Explore changes in clinical trial design being adopted in response to these challenges with reporting from Pink Sheet.

    Topic drug-development-landscape

    report

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

    14 Aug 2019

    Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

    Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

    Topic fda company-analysis

    article

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs

    09 Aug 2019

    The Stakes Are High So Get It Right: CHMP Oral Explanations & FDA AdComs

    The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. How they perform is critical. Consultant Kate Dion has a raft of helpful tips for companies facing this daunting situation. Neena Brizmohun reports.

    Topic drug-approval

    View article

  • Pink Sheet: 世界の薬事規制と承認審査に関するニュース

    FTC Wades Into ‘Rebate Walls’ And Biosimilar Access With Remicade Investigation

    09 Aug 2019

    FTC Wades Into ‘Rebate Walls’ And Biosimilar Access With Remicade Investigation

    Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.

    Topic policy-and-regulation

    article

医薬品産業専門のジャーナリスト＆アナリスト

Editor

Brenda Sandburg

Editor, Senior Editor

New York

Brenda Sandburg

Brenda specializes in

  • Policy and Regulation
  • Biosimilars
  • Biotech
  • Generics
  • Pricing

+38 year(s) experience

Profile
Editor

Cathy Kelly

Editor, Senior editor

Washington DC

Cathy Kelly

Cathy specializes in

  • Policy and Regulation
  • Market intelligence
  • Market Access
  • Pricing

+38 year(s) experience

Profile
Management

Denise Peterson

Management, Editor In Chief, Pharma US

Washington DC

Denise Peterson

Denise specializes in

  • Commercial Strategy
  • Policy and Regulation

+37 year(s) experience

Profile
See all analysts

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