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Medtech Insight

More Problems For Software Used In Baxter Spectrum IQ Infusion Pumps

By Shawn M. Schmitt 26 Aug 2021

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Baxter says customers complained of “multiple pumps within their fleets” encountering system errors after they made changes to their network configuration and server systems. It’s the second software-related setback for the device maker in recent weeks.

Medtech Insight

2 Deaths Linked To Missing IFU For Cardinal Health Scalpel Used For Newborns

By Shawn M. Schmitt 20 Aug 2021

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The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.

Scrip

Chinese Biotechs Join COVID-19 Treatment Race With Repurposed Cancer Drugs

By Dexter Yan 18 Aug 2021

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Chinese bioventures leap into the COVID cure fray as two little-known companies kick off clinical studies of androgen receptor antagonists in Brazil and the US.

HBW Insight

US FDA Focused On Vulnerable Populations As Cosmetic Risk Assessment Protocol Develops

By Ryan Nelson 17 Aug 2021

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The agency’s recent request for contractor quotes cites infants and children, people of color, and immunosuppressed individuals among users whose “unique biological characteristics” could require special consideration in the evaluation of cosmetic ingredients. The FDA also is interested in accounting for unique physicochemical aspects of ingredients such as engineered nanomaterials.

In Vivo

‘We Have A Lot Of Work To Do,’ Says Head Of HIV + Hepatitis Policy Institute

By William Masters 16 Aug 2021

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Progress in reducing HIV infections has plateaued in the US. But with bipartisan support, federal funding and momentum in drug development there is reason for optimism, says HIV + Hepatitis Policy Institute executive director Carl Schmid.

Pink Sheet

AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis

By Sue Sutter 16 Aug 2021

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After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.

Scrip

Quick Listen: Scrip’s Five Must-Know Things

By Ian Haydock 16 Aug 2021

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In this week's podcast edition of Five Must-Know Things: a history of Alzheimer’s drug development; BioNTech looks beyond COVID-19 vaccines; gene therapy setbacks for bluebird; new promise for Roche’s Polivy in B-cell lymphoma; and rising US momentum for US drug price negotiations.

HBW Insight

After US FDA Objects To CBD Safety As NDIs, Supplement Industry Responds, What Else Is New?

By Malcolm Spicer 13 Aug 2021

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Rejection of two firms’ proposals for using hemp-derived CBD in supplement isn’t stirring US businesses selling CBD supplements to pull products from market. For one firm that filed an unsuccessful NDI notification for full-spectrum hemp extract CBD, FDA rejection was agenda item with numerous other business, regulatory and legislative developments in its latest quarter.

Medtech Insight

Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls

By Ashley Yeo 13 Aug 2021

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There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.

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