Medtech Insight(メドテックインサイト)では、世界の医療機器・医療技術に関する最新の開発状況(臨床試験の結果、承認審査、市販後の更新情報等)や投資動向、ディール活動、参入企業の動きなど医療機器・医療技術産業全体の最新情報をお伝えします。
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Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Razor-thin majorities in both chambers of Congress mean Democrats can’t enact a bold agenda, and the pandemic and attendant recession mean that the initial legislative focus won’t be on Rx issues.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
The UK regulator, the MHRA, has published guidance on its new integrated pathway for innovative drug approvals, which it says is intended to bring together partners including health technology assessment agencies, health care bodies and patient organizations to offer “sustained collaboration” with drug developers.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Warp Speed’s Slaoui predicts vaccinations starting within days of the 10 December advisory committee for Pfizer’s coronavirus vaccine. Regeneron’s monoclonal cocktail follows Lilly’s antibody product with an EUA.
Topic Coronavirus FDA
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated
Topic Vaccines Coronavirus Distribution
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Topic Pharma-Brexit brexit Regulation
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
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
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
The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
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
An EU pilot project will assess whether there is sufficient demand from companies to obtain simultaneous scientific advice from EU national competent authorities.
Topic EU Innovation Regulation
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Building more cold chain warehouses, finding alternative sources of medicine supplies, and halting parallel exports to mitigate product shortages. Just some of the ideas for tackling the consequences of a no-deal Brexit scenario put forward by industry representatives at a recent parliamentary committee hearing.
Topic Pharma-Brexit brexit EU
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
The October panel will not review a specific application, but is expected to offer FDA advice on whether emergency use authorization is an appropriate pathway for COVID vaccines, and what data would be needed for full licensure. Sponsors may present data on their candidate vaccines.
Topic Coronavirus vaccines
Biomedtracker: 開発中医薬品をFDA承認確率で評価, Trialtrove: 医療用医薬品の臨床試験情報デ...
Access the infographic below which explores the number of treatment drugs for COVID-19 currently in clinical trials or in development, events including progress updates, partnerships, regulatory and trial announcements etc, and the number of articles published on COVID-19 as of March 3, 2020. This data has been tracked and reported via Informa Pharma Intelligence’s clinical, regulatory and commercial data and analytics, and news and insight tools including Biomedtracker, Trialtrove, Pharmaprojects, Scrip, Pink Sheet, Medtech Insight, and Generics Bulletin etc.
Topic Coronavirus
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.
Topic Manufacturing vaccines Coronavirus
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制動向＆情報を配信
25 Jan 2021
世界の薬事規制<br>動向＆情報を配信
24 Jan 2021
世界の薬事規制<br>動向＆情報を配信
22 Jan 2021
世界の薬事規制<br>動向＆情報を配信
22 Jan 2021
世界の薬事規制<br>動向＆情報を配信
22 Jan 2021
世界の薬事規制<br>動向＆情報を配信
22 Jan 2021
世界の薬事規制<br>動向＆情報を配信
22 Jan 2021
世界の薬事規制動向＆情報を配信
21 Jan 2021
世界の薬事規制動向＆情報を配信
21 Jan 2021
世界の薬事規制動向＆情報を配信
21 Jan 2021
世界の薬事規制動向＆情報を配信
21 Jan 2021
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