Pink Sheet: 世界の薬事規制と承認審査に関するニュース
16 Oct 2019
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.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
16 Oct 2019
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.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
14 Oct 2019
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
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...
30 Sep 2019
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
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
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.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
14 Aug 2019
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
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
09 Aug 2019
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
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
09 Aug 2019
Investigation may help define when rebate arrangements seeking to protect a brand against biosimilar competition are anticompetitive.
Topic 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
29 Jul 2019
A national pharmacare program in Canada could make it harder to access higher cost drugs.
Topic 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
26 Jul 2019
Price inflation rebates are expected to generate $50bn in savings over 10 years, according to the Congressional Budget Office.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
15 Jul 2019
Get expert insights into the events driving drug pricing polices around the world. This Article Pack covers drug pricing issues for: The EU - Vital developments for Norway, Denmark, and other EU countries, including the UK The US – Essential drug pricing info from a country where the issue has taken center stage Australia – Developments surrounding drug pricing issues in Australia
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Francesca Bruce 05 Jul 2019
Latin American joint price negotiations have proved successful and other countries are taking note.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Vibha Sharma 04 Jul 2019
Four drugs are up for an opinion this week on whether they should be granted EU-wide approval, including Amgen/UCB's osteoporosis drug romosozumab.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Brenda Sandburg 03 Jul 2019
Fallout from Supreme Court's Escobar decision and Department of Justice memos could impact types of healthcare fraud complaints in which the government intervenes.
Topic drug-approval strategy
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By Brenda Sandburg 03 Jul 2019
'Number of different initiatives' coming in next several months to make drugs more affordable, including for PrEP prophylaxis, HHS Assistant Secretary for Health Giroir says. Multi-agency approach is key strategy.
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15 Oct 2019
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Biomedtracker(バイオメドトラッカー)は開発中の医療用医薬品の承認に影響を与えるイベントをリアルタイムで追跡し、アメリカ食品医薬品局(FDA)の承認確率(LOA: Likelihood of Approval)で示すデータベースです。臨床試験の結果や学会発表、ライセンス活動や規制当局の動きなど、開発中医薬品の商業的可能性に影響を与える過去と未来のイベントを包括的に分析し、承認確率として算出するデータベースサービスです。
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