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BioWorld - Sunday, April 5, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for May 12, 2021

May 12, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Bioecho Life Sciences, Desktop Health, Chordate Medical, Endologix, Johnson & Johnson Vision, Qiagen.
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Other news to note for May 12, 2021

May 12, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Burning Rock Biotech, Cyduct Diagnostics, E Ink, Ers Genomics, Flagship Biosciences, Fluorogenics, Fujifilm, Galaxy Medical, Genscript Biotech, Helio Health, Hhc Preferred, Japan Lifeline, Leap Therapeutics, Lucira, New England Biolabs, Novartis, Nuclera Nucleic, Pmb-Alcen, Sagentia Innovation, Sientra, Tilak Healthcare, Wearable Health Solutions.
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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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Pandemic recovery key theme of Australia’s budget with med-tech, biotech sectors praising new measures

May 12, 2021
By Tamra Sami
PERTH, Australia – Australia’s budget theme for the 2021 to 2022 fiscal year is rebuilding the economy following COVID-19, and med-tech and biotech leaders were praising some of the new measures.  
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Other news to note for May 12, 2021

May 12, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atai, Atyr, Azurrx, Biogen, Caladrius, Cassava, Cellectis, Diurnal, Citrine, ERS, Exelixis, Genfit, Genscript, Inovio, Intelgenx, Ipsen, Iqvia, Lianbio, Moderna, Nanobiotix, Protokinetix, Respirerx, Rubius, Sanofi, Voyager, Xilio.
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In the clinic for May 12, 2021

May 12, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ADC, Algernon, Amylyx, Biomarck, Biophytis, Cage, Checkpoint, Clene, Connect, Constant, Context, Graybug, GT, Incyte, Inflarx, Magenta, Medeor, Minerva, Morphosys, Ocuphire, Providence, Qpex, Scholar Rock, Ultimovacs, VBI.
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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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Pfizer: IP not the vaccine bottleneck

May 11, 2021
By Mari Serebrov
In an open letter to Pfizer Inc. employees, the company’s CEO, Albert Bourla, provided some insight about why some countries don’t have COVID-19 vaccines and others have a surplus. It has nothing to do with intellectual property (IP), or even price, Bourla said.
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Other news to note for May 11, 2021

May 11, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Bionostica, Applied DNA Sciences, Biointellisense, Castle Biosciences, Cytosorbents, Doctor On Demand, Grand Rounds Health, Ott Scientific, Protech Home Medical, Quipt Home Medical, Speedx, Veemed.
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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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