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In Vivo: 医療用医薬品・医療機器産業の経営層向けニュース, Scrip: 世界の医...

Webinar: Is Biopharma Fit For the New Decade?

Webinar: Is Biopharma Fit For the New Decade?

Download your article pack now for a glimpse of some of the topics that will be covered by our panel of experts during the “Is Biopharma Fit for the New Decade?” webinar.

Topic Cell and gene therapy Policy and regulation

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

China Coronavirus Cases Up Sharply As Pharma Rushes To Aid

AbbVie’s HIV therapy Kaletra is now being used by the Chinese government to treat coronavirus-infected patients after a respiratory expert endorsed its use, while other pharma companies from Bayer to Innovent are showering support as China battles its worst virus outbreak since the SARS epidemic 17 years ago.

Medtech Insight: 世界の医療機器・医療技術の最新情報

CDC Shares Blueprint For Coronavirus Diagnostic With US State Laboratories

A new coronavirus test template developed by the US Centers for Disease Control and Prevention is being refined by the agency so it can be shared with domestic and international partners to help identify more cases of the virus.  In the meantime, state labs can use the posted assay for coronavirus on the CDC’s website for testing of residents within their jurisdiction and send results to the CDC.

Medtech Insight: 世界の医療機器・医療技術の最新情報

Diagnostics Development For Coronavirus Begins As Second US Patient Tests Positive

Bioresearchers at the Centers for Disease Control and Prevention are hoping that diagnostic platforms previously used to develop tests for outbreaks of other epidemic respiratory diseases, including SARS and MERS, can be built on to develop new diagnostics to detect more cases in the current coronavirus outbreak, US infectious disease authorities say. This comes as more patients are monitored around the US for the disease, and a Chicago woman returning from China tests positive.

Topic Drug approval Clinical Trials Coronovirus Policy and regulation

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA ‘Stands Ready’ To Fight Coronavirus Via Emergency-Use Test Kits While WHO Mulls Virus Spread, Gets Out Guidance

The US Food and Drug Administration (FDA) stands poised to proceed with hastened approvals for 2019-coronavirus (nCoV) diagnostics, treatments and vaccines, if a public health emergency is declared, after an infected US traveler who caught the disease in Wuhan, China returned from the province to Washington State. Spread of the disease has reached a crisis level in China, and the World Health Organization met on 22 and 23 January to consider what actions to take to contain the virus, while issuing an interim laboratory test guidance for use in diagnosing the disease.

Topic drug-approval clinical-trials Coronovirus 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

China Coronavirus Outbreak Response Critical As First US Case Confirmed

A quickly spreading coronavirus outbreak in China could upend the country’s healthcare priorities as the health regulators and reimbursement agency officials gear up to “control and prevent” the worst public health emergency since the deadly SARS outbreak in 2003.

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

Pink Sheet: 世界の薬事規制と承認審査に関するニュース

A Visual Guide To US FDA's Evolutionary Decade In Review

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

Topic fda policy-and-regulation

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