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BioWorld - Sunday, December 28, 2025
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Illustration of mouse with chip implant

Columbia neuroelectronic system could improve epilepsy treatment and reduce side effects

May 13, 2021
By Annette Boyle
In the last decade, responsive neurostimulation (RNS) has become a mainstay of treatment for refractory focal epilepsy, but challenges with the technology remain. Researchers at Columbia University in New York appear to have overcome some of the major limitations through development of a compact, flexible, high performance implantable device that permits reading and manipulation of brain circuits.
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Digital heart illustration

Egnite aims to spark change in structural heart disease care with new predictive suite

May 12, 2021
By Annette Boyle
Egnite Inc. emerged from stealth mode in February 2021 with the goal of combining data analytics and digital health technology to illuminate and solve persistent issues in the diagnosis and treatment of structural heart disease. Three months later, it has added artificial intelligence (AI) to its flagship solution, Cardiocare, to drive better diagnosis of aortic stenosis and help physicians predict patient outcomes.
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Syringes in an apple

ACIP says yes to EUA expansion, caught off-guard by change in CDC guidance

May 12, 2021
By Mari Serebrov
It came as no surprise May 12 that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, to recommend the use of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), in 12- to 15-year-olds following the FDA’s decision earlier this week to expand the vaccine’s emergency use authorization (EUA) to that age group.
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World trade illustration

Déjà vu sets in with Special 301 Report

May 11, 2021
By Mari Serebrov
The 2021 Special 301 Report recently released by the U.S. Trade Representative is mostly déjà vu for the 32 countries included on the Priority Watch and Watch Lists, as all of them have appeared before on the lists that call out U.S. trading partners for unfair IP practices that disadvantage foreign companies.
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regulatory-washington-white-house-president.png

U.S. change of course on IP waiver facing backlash

May 11, 2021
By Mari Serebrov
The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.
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Vaccine and data illustration

U.S. switches stance on IP waiver, sponsors promise revision

May 11, 2021
By Mari Serebrov
Once again, the World Trade Organization postponed a decision on a temporary IP waiver for COVID-19 vaccines and other related medical products.
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U.S. EPA building

U.S. EPA OIG prods agency to revisit ethylene oxide question

May 11, 2021
By Mark McCarty
The controversy over the use of ethylene oxide (EtO) is back in play, thanks to a May 5 letter from the Office of Inspector General at the Environmental Protection Agency to the EPA. The letter recommends that the agency revisit its work on determining the status of EtO based on new data, data that may lead to more restricted use of EtO to sterilize medical devices.
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COVID-19 vaccine vial on ice

U.S.-supported patent waiver meets with skepticism in Asia

May 11, 2021
By David Ho, Gina Lee, and Elise Mak
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
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U.S. vaccine illustration

U.S. turning point in sight, but innovation still needed in COVID-19 fight

May 11, 2021
By Mari Serebrov
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
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Pfizer-Biontech COVID-19 vaccine vial

FDA expands EUA for Pfizer-Biontech COVID-19 vaccine to adolescents

May 11, 2021
By Michael Fitzhugh
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
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