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BioWorld - Wednesday, April 15, 2026
Home » Topics » Infection » Coronavirus

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U.S. FDA headquarters

FDA’s Stenzel says agency ‘very interested’ in fingerstick serology as POC screening test

July 24, 2020
By Mark McCarty
The question of screening for the COVID-19 pandemic continues to absorb the interest of both the U.S. FDA and test developers, and Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said in a July 22 webinar that the FDA is “very interested” in a fingerstick test at the point of care for screening purposes, adding that the agency sees any such applications as a priority.
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Device in heart

Edwards exceeds Wall Street expectations in Q2, in spite of COVID-19

July 24, 2020
By Meg Bryant
Edwards Lifesciences Corp. reported better-than-expected results when it released its second quarter earnings late July 23, with revenue down 15% to $924 million, from $1.1 billion in the same period of 2019. The results beat Wall Street consensus of $797.5 million, and reflected an uptick in surgical procedures that had been delayed by the COVID-19 pandemic. The Irvine, Calif.-based company sustained a net loss of $121.9 million, or $0.20 per share, based on generally accepted accounting principles (GAAP), a sharp drop from $242.3 million, or $0.38 per share, in the same quarter last year. However, adjusted earnings looked brighter at $0.34 per share.
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Other news to note for July 24, 2020

July 24, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aroa Biosurgery, A*Star, Baxter International, Bionano Carequality, Dt Medtech, Genetworx, Genomics, Haemonetics, HintMD, Inlog Holdings France, Joimax, Lifehealthcare, Medalliance, Microgendx, Mp Biomedicals, Progenity, Redox, Revance, Synchron, Vilex, Vipun Medical.
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In the clinic for July 24, 2020

July 24, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: enscript, Polarityte.
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BioWorld MedTech’s Neurology Extra for July 24, 2020

July 24, 2020
By Andrea Applegate
Keeping you up to date on recent developments in neurology, including: Novel drug delivery particles use neurotransmitters as a 'passport' into the brain; SARS-CoV-2 infection of non-neuronal cells, not neurons, may drive loss of smell in patients with COVID-19; Pandemic to accelerate adoption of electronic patient portal for epilepsy.
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Scissors cutting Euro

‘Shrinking’ Horizon as EU leaders cut R&D funding even as researchers fight pandemic

July 24, 2020
By Nuala Moran
LONDON – Research and health emerged as the biggest losers following a marathon four days of negotiations by EU leaders on the bloc’s €1.1 trillion (US$1.3 trillion) 2021 - 2027 budget and the formation of a €750 billion (US$872 billion) pandemic recovery fund. Rather than €94.4 billion over the next seven years as proposed, the R&D program Horizon Europe, will get €80.9 billion.
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Asia at night from space
BIO Asia-Taiwan 2020

Boosted by COVID-19 success, Taiwan life sciences sector building government, investor support

July 24, 2020
By Elise Mak
With no new cases reported for more than 100 days, Taiwan appears to have successfully contained the spread of COVID-19 and has drawn attention to its medical achievements. Experts said at BIO Asia-Taiwan conference this week that with continuous government and investor support, the East Asian nation could move further up to join other leading biotech players.
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Other news to note for July 24, 2020

July 24, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptorum, Arcturus, Cel-Sci, Fujifilm, Hansoh, Menarini, Novavax, Protalix, Radius, Sarcomed, Sareum, Sorrento, Smartpharm, Tissue Regenix.
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Telehealth illustration

CBO scoring a significant hurdle in proposals to permanently expand telehealth coverage

July 23, 2020
By Mark McCarty
The support for permanent changes to Medicare coverage of telehealth has risen drastically in the months since the COVID-19 pandemic began, but Krista Drobac of Sirona Strategies said on a July 23 webinar that stakeholders will have to help make the case that telehealth is cost effective. That cost effectiveness argument may be absolutely crucial if any of the related legislative proposals are to stand up to budget scoring in a time of skyrocketing U.S. budget deficits, she said.
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Regulatory front for July 23, 2020

July 23, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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