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
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
.jpg "NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission")
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
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
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
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
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
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
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
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'
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'
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'
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
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
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
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
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