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Biomedtracker: 開発中医薬品をFDA承認確率で評価, Datamonitor...

2020 Early Outlook Webinar

By Michael ​ Haydock 28 Feb 2020

Anticipate the biggest, most impactful expected catalysts of early 2020 with the guidance and insights from Pharma Intelligence. Building off Biomedtracker’s Early 2020 Outlook report, our live webinar will include market context for these upcoming milestones and additional insights from Datamonitor Healthcare’s Therapeutic Area Directors.

Topic fda

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

US Researchers Working Toward Universal Coronavirus Vaccine

18 Feb 2020

Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Coronavirus Supply Chain Threats Demand Coordinated Industry Response

18 Feb 2020

Just as they did during the heparin crisis a decade ago, pharmaceutical companies must coordinate on coronavirus, Rx-360 CEO says.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

18 Feb 2020

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

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.

Topic Infectious Diseases Vaccines Coronavirus

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

For Coronavirus US FDA Is At The Podium But Not On The Task Force

18 Feb 2020

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.

Topic fda vaccines infectious-diseases Coronavirus

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

18 Feb 2020

72 Products Approved Under Expanded Emergency Pathway A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

UK Firms Asked To Check Coronavirus Supply Chain Impact

18 Feb 2020

Authorities Also Investing In Vaccines And Tests Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

A Positive Outlook For Deals, With Election Year Caveats

17 Feb 2020

Industry advisers at the BIO CEO & Investor meeting remained optimistic about the pharmaceutical deal environment in 2020 – even with the uncertainty around a looming US election year.

Topic biopharmaceutical

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Another Alzheimer's Setback As Roche And Lilly Drugs Fail

17 Feb 2020

As Biogen moves to file its controversial amyloid drug aducanumab for approval in the US, two similar investigational Alzheimer's drugs – Eli Lilly's solanezumab and Roche's gantenerumab – did not slow memory loss or cognitive decline in a rare, inherited form of the disease.

Topic Alzheimer's Disease

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