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BioWorld - Sunday, December 10, 2023
Home » Topics » Infection » Coronavirus

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U.S. Securities and Exchange Commission

SEC clamping down on companies’ COVID-19 claims

April 16, 2020
By Mari Serebrov
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Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
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Regulatory front for April 16, 2020

April 16, 2020
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The latest global regulatory news, changes and updates affecting biopharma, including: Amneal.
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Regulatory actions for April 16, 2020

April 16, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai.
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Other news to note for April 16, 2020

April 16, 2020
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acucela, Aeterna, Al Vivo, Atlas, Azurrx, Batavia, Biogen, Biohaven, Botanix, Cerespir, Cevec, Clinigen, Dynavax, Eagle, Elicio, Evotec, Evox, Fairjourney, F-star, Fusion Antibodies, Galapagos, Immutep, Iksuda, Inovio, Iontas, Jaguar, Kubota, Legochem, Leo, Leon-Nanodrugs, Medison, Napo, Novartis, Octapharma, PDS, Porton, Pulmatrix, Ryvu, SAB, Scitech, Sinovac, Soligenix, Starpharma, Synthon, Turning Point, Urogen, Valbiotis, Vivoryon.
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In the clinic for April 16, 2020

April 16, 2020
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Adial, Affimed, Amag, Biosig, Indivior, Inovio, Magenta, Novavax, Nucleus, PDS, Roivant, Sunovion, Vir.
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Hand holding dollar sign

Chinese investors continue to show appetite for biopharma and med tech, with Qiming’s $1.1B fund

April 15, 2020
By Elise Mak
No Comments
BEIJING – During the market downturn caused by COVID-19 disruptions, biotech and med-tech companies continue to attract investors at a time when medical solutions are needed more than ever. Qiming Venture Partners said that it has established a new $1.1 billion fund to target early stage health care and technology investments, the latest good news sector for biopharma and med-tech startups.
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WHO headquarters, Geneva

EU leaders pan Trump’s move to halt U.S. funding as WHO updates COVID-19 response plan

April 15, 2020
By Nuala Moran
No Comments
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
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COVID-19, coronavirus paper dolls

Mass fever scanner could reduce spread of COVID-19

April 15, 2020
By Meg Bryant
No Comments
As state and federal authorities deliberate over how to safely reopen U.S. society during the ongoing COVID-19 pandemic, tools that effectively monitor body temperature at a population level could help to get the ball rolling. To that end, software development firm Altoros Inc., of Sunnyvale, Calif., has released the Fever Screener, a fully automated, enterprise-grade system for setting up temperature scanning checkpoints. Fever Screener can scan up to 30 people simultaneously at a distance of 3 meters, or nearly 10 feet, with a temperature accuracy of roughly 0.6 degrees Fahrenheit. Installed in entryways, checkpoints or other crowded venues, it can provide mass screenings, as well as recurrent temperature monitoring for potentially infected individuals.
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Business pipeline illustration

J&J beats Wall Street expectations for Q1, but medical devices hit hard by COVID-19

April 15, 2020
By Stacy Lawrence
No Comments
Johnson & Johnson (J&J) managed to beat analyst earnings estimates due to unexpectedly strong first-quarter results in its consumer health and pharmaceutical businesses. But while those saw revenues climb in the double digits, its medical devices business declined by almost 5% due to deferred procedures. Wall Street rewarded the New Brunswick, N.J.-based company by driving its shares (NYSE:JNJ) up more than 5%. That’s even though the company also lowered its 2020 guidance.
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Respiratory infection

FDA’s Stenzel: EUA for COVID-19 home collection sample kit will happen ‘very soon’

April 15, 2020
By Mark McCarty
No Comments
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
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