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Medtech Insight: 世界の医療機器・医療技術の最新情報

QUOTED. 24 January 2020. Megan McSeveney.

The FDA has readied plans for hastened emergency-use approvals of coronavirus test kits after an infected US citizen returned to Washington State from Wuhan province in China. See what the FDA’s Megan McSeveney said about it here.

Topic Drug approval Coronovirus FDA

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

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Podcast: Significant Approvals, Diabetes and NASH In India, Japan M&A

Join the Asia-based content team for Scrip and the Pink Sheet for their first podcast as they take a look at some of the most significant regional pharma stories of the past few weeks.

Topic drug-approval business-strategies

Medtech Insight: 世界の医療機器・医療技術の最新情報

FDA Launches Pilot Program To Streamline EtO Facility, Process Changes

Article

As concerns continue to mount over a potential shortage of medical devices due to the closure of ethylene oxide (EtO) facilities, the US agency is looking for nine sterilizers in a pilot project that could allow them to get facility and process changes approved faster.

Datamonitor Healthcare: 医療用医薬品の市場調査レポート

オンラインセミナー:NASH治療薬の展望と市場動向

オンラインセミナー:NASH治療薬の展望と市場動向

NASH(非アルコール性脂肪性肝炎)はさらに大きな流行病となりつつあり、あらゆる規模の企業が、業界初のNASH治療薬を市場に出すためにしのぎを削っています。新薬および転用された新薬探索、NASHの治療に関する詳細なディスカッション、およびこの分野のディールメイキング、ライセンスシング、提携戦略についてお聞きください。

Topic cell-and-gene-therapy drug-development-landscape drug-approval

Datamonitor Healthcare: 医療用医薬品の市場調査レポート

NASH治療薬の価格戦略を考察する・無料ホワイトペーパー

NASH治療薬の価格戦略を考察する・無料ホワイトペーパー

NASH(非アルコール性脂肪性肝炎)治療薬の価格戦略を考察する無料ホワイトペーパー『Insight into NASH Pricing Strategies(全12頁)』です。後期臨床試験に進むパイプラインの数は増えているにもかかわらず、NASH市場の将来は不透明です。患者、保険者、製造業者を含むすべての関係者を満足させるため、NASH治療薬の持続的な価格戦略について多くの議論が行われています。

Topic drug-approval business-strategies

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

J&J's Spravato Set For EU Launches Soon

Ketamine-Like Antidepressant Backed By CHMP If the nasal spray is approved by the European Commission, seven months after getting the green light in the US, Spravato will offer the first new mechanism of action in 30 years to treat major depressive disorder.

Topic drug-approval drug-development-landscape

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