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insight analysis pharma intelligence




  • インフォーマ・ファーマインテリジェンスでは、承認済み医薬品または開発パイプラインの展望、ならびに承認に向けたスケジュールを立てるためのツールと情報を提供します。作用機序または薬剤分類ごとに選別されているため、大きな時間短縮になります。
  • デバイス/診断、特にFDAおよびCEマークの承認に関する包括的で正確な規制情報を見つけることもできます。



  • 最新の薬事規制動向
  • 競合品のラベルクレームを予測し、御社の製品が市場において将来的に有望であることを確認
  • 臨床開発計画において誤った判断を避けるために、臨床試験が中止となった類似薬の事例から学ぶ
  • 規制当局の優先審査指定を得るために成功(および不成功)した戦略を理解し、開発計画に組み込む
  • 業界トップのアナリストを活用して、御社の顧客のリサーチニーズに対応




HBW Insight : コンシューマーヘルスケア産業のニュース

HBW Insightでは、市販薬(OTC)、ビタミンなどのサプリメント(栄養補助食品)、化粧品、衛生用品やスキンケアなどコンシューマーヘルスケア産業のニュースをワンストップでお届けします。ビジネスの動向だけでなく、規制や法律に関しても専門アナリストの分析と見解を交えてお伝えします。今後ますますグローバル化する業界の機会とリスクを予測するのに役立ちます。

Key benefits:

  • 世界のコンシューマー ヘルスケア産業を把握
  • 市場の最新ニュースと 予測を誰よりもはやく
  • 国際競争力を強化する独自のニュースと分析

Generics Bulletin: ジェネリック&バイオシミラーニュース

インフォーマ・ファーマインテリジェンスのGenerics Bulletinは、過去15年間にわたってジェネリック医薬品(後発医薬品)、バイオシミラー(バイオ後続品)、付加価値医薬品業界の情報源として多くの方に読まれてきました。最新の規制、法律、市場動向を把握し、潜在的な脅威と機会の予測にお役立てください。

Key benefits:

  • 世界のジェネリック& バイオシミラーを把握
  • 国際競争力を強化する独自のニュースと分析
  • オンラインでアクセスできるから簡単&便利


Key benefits:

  • Manage portfolio risks
  • 成功要因の分析
  • Create meaningful benchmarks


  • 世界の薬事規制動向&情報を配信

    US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion


    CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

  • Generics Bulletin: ジェネリック&バイオシミラーニュース

    Overseas API Manufacturing Identified As Key Vulnerability In US Supply Chain


    After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    Bayer Leads Push For Self-Care In India As Local Business Launches


    Bayer has launched a dedicated Consumer Health business in India to market products in key OTC categories. The company is also working to bring different stakeholders together through the creation of a new organization dedicated to promoting self-care in the South Asian country.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    New York’s Age Restrictions On Weight Loss, Sports Supplement Sales Fail To Fly


    New York legislation to restrict sales of weight loss and sports nutrition supplements to minors failed without reaching a vote before the end of the session. But the proposal will continue to be a challenge for industry in New York as well as around the country.

  • Generics Bulletin: ジェネリック&バイオシミラーニュース

    Celltrion Opens Up Canadian Market For Remsima SC


    Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.

  • 世界の薬事規制動向&情報を配信

    Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial


    Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    US FDA’s Preferred Special Treatment For Cannabinoids Points To Mistreating Industry


    Senate bill provision allowing FDA to develop unique labeling and packaging for cannabinoid supplements and foods is unnecessary, as the products should following existing labeling regulations, says CRN chief Steve Mister.

  • 世界の薬事規制動向&情報を配信, Scrip: 世界の医療用医薬品&製薬産業に関するニュース

    Drug Pricing eBook

    Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.

    Topic drug-pricing

  • In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース, 世界の薬事規制動向&情報を配信

    Manufacturing and Distribution: Challenges and Opportunities

    The COVID-19 pandemic has brought about significant manufacturing and distribution challenges and opportunities for Pharma. Seize new opportunities and avoid risk with the strategic commercial and regulatory intelligence you need to stay competitive by subscribing to Pink Sheet and In Vivo.

    Topic strategy

  • 世界の薬事規制動向&情報を配信

    US COVID Vaccine Patent Waiver Is Big, Symbolic Blow For Pharma, But The Fight Is Just Beginning


    Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    Germany's OTC Market Struggling To Recover To Pre-Pandemic Levels


    As Germany remains in lockdown, sales in its OTC market struggle to return to pre-pandemic levels, according to new data from Sempora Consulting. Meanwhile, COVID-related trends for wellness and online shopping endure, indicating some strategic priorities for OTC firms operating in the country. 

  • Generics Bulletin: ジェネリック&バイオシミラーニュース

    Industry Steps Up To Help India Through Second Wave


    As India sees a consistent rise in daily cases and deaths due to COVID-19, the off-patent industry is stepping up to make drugs affordable and available. Zydus Cadila is seeking approval for virafin, while Natco has applied for molnupiravir approval. Vaccine production and availability has also come under focus. 

  • Generics Bulletin: ジェネリック&バイオシミラーニュース

    European Biosimilars Can Benefit From Sharing Experiences


    Attendees to Medicines for Europe’s virtual summit on biosimilars heard how learning from experiences across Europe can allow individual countries to build a toolbox of policies to help create a sustainable biosimilars market.

  • 世界の薬事規制動向&情報を配信

    Long-Awaited EU Clinical Trials Portal Meets Major Milestone


    A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.

  • HBW Insight : コンシューマーヘルスケア産業のニュース

    NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission

    NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission

    NIH pays for 2m of Quidel's QuickVue tests in a program it’s conducting with CDC to determine whether frequent self-administered testing helps reduce community transmission of SARS-CoV-2.