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Luminex Will Be Acquired By DiaSorin For About $1.8Bn

Italian diagnostics company DiaSorin SpA agreed to buy Luminex Corporation for about $1.8bn in an all-cash transaction.DiaSorin said on 11 April the acquisition of Austin, TX-based Luminex, ..... see more

Source : Medtech Insight

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FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation

An independent report on the US Food and Drug Administration’s COVID-19 response is spurring the agency to make some changes intended to improve how it handles emergency use authorization applications ..... see more

Source : Medtech Insight

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NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission

A COVID-19 test recently cleared for over-the-counter (OTC) sales in the US will do more than expand consumer access to tests for infections. The National Institutes of Health is paying for ..... see more

Source : Medtech Insight

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Diagnostic Company LumiraDX Goes Public In $5Bn SPAC Merger

Diagnostic company LumiraDX announced it will merge with blank check company CA Healthcare Acquisition Corp. in a deal that is valued at $5bn. The deal, announced on 7 April, is ..... see more

Source : Medtech Insight

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Analyst Insight: Stay At Home, Work At Home, Image At Home?

Imagine your child runs into the house crying after falling on their arm while playing outside. You quickly grab the first aid kit and a small portable X-ray system. A ..... see more

Source : Medtech Insight

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CDC Awards Counterfeit Mask Prevention Contract To Underwriter Laboratories

Safety certification company Underwriter Laboratories is set to land a contract with the US Centers for Disease Control and Prevention (CDC) to develop strategies to prevent the sale and distribution ..... see more

Source : Medtech Insight

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First At-Home COVID-19 Serology Test From Symbiotica Granted EUA By FDA

The first at-home serology test has been granted emergency use authorization (EUA) by the US Food and Drug Administration, the agency announced on 6 April.The COVID-19 Self-Collected Antibody Test System ..... see more

Source : Medtech Insight

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Ellume CEO Ponders Future Of Company’s Rapid COVID-19 Antigen Test

Earlier this year the Biden administration made a big bet on small Australian test maker Ellume by giving the company $231m to build a plant in the US to mass ..... see more

Source : Medtech Insight

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Lucira Health’s Unexpected Sprint To A First-Of-Its-Kind EUA From FDA: The Inside Story

It was early 2020, and Lucira Health was busy working on an at-home test for detecting influenza A and B when the first reports of a novel coronavirus began trickling ..... see more

Source : Medtech Insight

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French Market Survives On New Generics

Despite the turmoil of the COVID-19 pandemic, France’s generics market maintained its trajectory in 2020, according to the latest data published by local industry association Gemme.For the reimbursable generics market, ..... see more

Source : 'Generics Bulletin'

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UK Weathers Challenges Of COVID-19 And Brexit

Over the past year, Brexit and the COVID-19 pandemic have represented two major threats to the smooth functioning of the UK generics and biosimilars market. And after discussing how far ..... see more

Source : 'Generics Bulletin'

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FDA Guides On Generic Development During COVID-19

The US Food and Drug Administration has published fresh guidance giving abbreviated new drug application developers advice on how to operate during the COVID-19 pandemic, in the form of a ..... see more

Source : 'Generics Bulletin'

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COVID-19: FDA Schedules 4 More Virtual Town Halls Through April

The US Food and Drug Administration is continuing its run of virtual town halls aimed at labs and manufacturers that are (or have) developed diagnostic tests for COVID-19.The FDA announced ..... see more

Source : Medtech Insight

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Coronavirus Mutations: FDA Singles Out 4 Molecular Tests That Can Give False Readings

The US Food and Drug Administration has published a page on its website to update stakeholders about how mutations in the SARS-CoV-2 virus cause lower sensitivity of some COVID-19 tests ..... see more

Source : Medtech Insight

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BTG SP Makes A Virtue Of Manufacturing And Supply Discipline Despite COVID

No noise and no drama. It is a precept that has been keenly respected by the staff and management of BTG Specialty Pharma over the past few years, much to ..... see more

Source : IN VIVO

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FDA No Longer Accepting Certain Face Mask EUAs, Signaling A More Manageable Pandemic

The US Food and Drug Administration has updated its emergency use authorization (EUA) list of imported disposable filtering facepiece respirators (FFRs) for health care workers for the last time. The ..... see more

Source : Medtech Insight

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Thermo Fisher Develops Sentry Device To Detect COVID-19 In The Air

In a bid to improve the surveillance of COVID-19 in hospitals, Thermo Fisher Scientific announced the release of its AerosolSense Bioaerosol Sampler on 24 March.The device, roughly the size ..... see more

Source : Medtech Insight