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BioWorld - Sunday, December 28, 2025
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Gavel and pill blister packs

Biologic patent thickets, global settlements at stake in 7th Circuit case

Feb. 25, 2021
By Mari Serebrov
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
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Woman using Appliedvr virtual reality headset at home

Appliedvr releases pivotal data on virtual reality-based pain therapy

Feb. 24, 2021
By Meg Bryant
In 2020, Appliedvr Inc. reported results from a three-week proof-of-concept study showing reduction of lower back pain with the use of its Easevrx virtual reality (VR) therapy. Now the company has pivotal data affirming the benefit to patients with chronic low back pain who used Easevrx at home for eight weeks.
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Product image

Pixcell Medical’s Hemoscreen going RURAL as part of research initiative

Feb. 24, 2021
By Annette Boyle
The National Institutes of Health selected Pixcell Medical Ltd.’s Hemoscreen hematology analyzer as part of the six-year Risk Underlying Rural Areas Longitudinal (RURAL) research study, aiming to gain insight into the specific health-related concerns of the rural southeastern United States' population. The RURAL study is funded by the National Heart, Lung and Blood Institute and aims to understand health concerns specific to rural communities in the South, particularly related to increased rates of heart, lung, blood and sleep disorders.
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Xavier Becerra, HHS secretary nominee

Price transparency emphasized in Becerra’s first Senate hearing for HHS job

Feb. 23, 2021
By Mark McCarty
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice.
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In congressional update, vaccine makers stress manufacturing complexity

Feb. 23, 2021
By Mari Serebrov
In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization to waive intellectual property protection for SARS-CoV-2 vaccines.
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Product image

Lexagene Miqlab detects U.K. and South African variants

Feb. 22, 2021
By Annette Boyle
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
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Phlebotomist draws blood from patient

CMS to cover blood-based tests for CRC screening, but no FDA-approved tests qualify

Feb. 22, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
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Architectural pillars

Grassley again eyes peel-back of materiality standard under Supreme Court’s Escobar decision

Feb. 19, 2021
By Mark McCarty
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.
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Device image

Rhythmedix rolls out next-gen wearable cardiac monitor

Feb. 18, 2021
By Meg Bryant
Cardiac monitoring company Rhythmedix Inc. reported the launch of its next-generation, wearable Rhythmstar device with built-in 4G cellular connectivity. The low-profile, water-resistant cardiac telemetry monitor provides extended remote monitoring to quickly detect arrhythmia without the need for a phone or other communication device.
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UCSD patch on skin

UCSD skin patch integrates heart health and biochemical monitor

Feb. 18, 2021
By Annette Boyle
Researchers at the University of California San Diego (UCSD) have taken wearables to a new level with a soft skin patch that integrates functions currently siloed in continuous glucose monitors, wearables, wellness apps and hospital monitors. The all-in-one patch can be worn on the neck to continuously track blood pressure, heart rate, glucose, lactate, alcohol and caffeine.
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