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BioWorld - Thursday, April 9, 2026
Breaking News: Best of BioWorld: Q1Breaking News: Best of BioWorld Science: Q1
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Veralox lands orphan status for thrombocytopenia candidate

Jan. 26, 2021
By Michael Fitzhugh
Veralox Therapeutics Inc., a Maryland-based startup developing a small molecule for halting aberrant platelet activation and thrombosis, said the FDA has granted the candidate, VLX-1005, orphan drug status for the treatment of heparin-induced thrombocytopenia (HIT).
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Cancer cells
Newco news

Market ‘solutes’ Nirogy small-molecule flag with $16.5M series A

Jan. 26, 2021
By Randy Osborne
Boston-based Nirogy Therapeutics Inc.’s $16.5 million series A round is meant to enable a pipeline of small-molecule drugs targeting the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane, and let the firm bring its front oncology runner to the clinic in 2022.
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Antibodies attacking SARS-CoV-2 virus

Regeneron and Lilly antibody studies produce positive COVID-19 data

Jan. 26, 2021
By Lee Landenberger
Regeneron Pharmaceuticals Inc. posted positive initial results from its ongoing phase III study of its monoclonal antibody cocktail, REGEN-COV (casirivimab and imdevimab), used as a passive vaccine, designed to provide immediate short-term passive immunity to prevent COVID-19 in people at high risk of infection due to household exposure to a COVID-19 patient. Eli Lilly and Co. reported upbeat news the same day, as the phase III Blaze-1 trial testing its antibody cocktail met its primary and key secondary endpoints.
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U.S. flag and White House podium

Biden EOs keep on coming

Jan. 26, 2021
By Mari Serebrov
In signing an executive order (EO) on strengthening American manufacturing Jan. 25, President Joe Biden made it clear that the order is aimed at more than infrastructure. While Biden’s Build Back Better Recovery Plan calls for investing hundreds of billions of dollars in buying American products and materials to modernize the nation’s infrastructure and increase its competitiveness, “it also means replenishing our stockpiles to enhance our national security,” the president said.
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FDA Approved stamp with pills, bottle, blister pack

FDA approves record number of NMEs in 2020

Jan. 26, 2021
By Peter Winter
Following the FDA giving the green light to seven new medicines in December, it brought the approval total of new molecular entities (NMEs) in 2020 to 53, an amount that equals the number of new medicines that were approved in 1996 and ranking it second equal all-time just behind the 59 NMEs that were approved in 2018.
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Regulatory front

Global initiative to take on Alzheimer’s

Jan. 26, 2021
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: Endo, Impax under antitrust scrutiny again; More on EMA cyberattack.
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Regulatory actions for Jan. 26, 2021

Jan. 26, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biontech, Cardiff, Cidara, Edesa, Faron, Fosun, Immunicum, Meiragtx, Merck, Mundipharma, Nanoscope, OS Therapies, Recordati, Veralox, Vertex.
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Other news to note for Jan. 26, 2021

Jan. 26, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief:Aclipse, Adagio, Adamis, Adial, Allarity, Amarin, Aslan, Atai, Bicycle, Bridgebio, Curadigm, Eidos, Entasis, Enzychem, Galmed, Health Net, Humanetics, I-Mab, Janssen, Moderna, Morphosys, Nanobiotix, Pharmacyte, Sanofi, Silo, Synaptogenix, Therapeutic Solutions, Vaxart.
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Financings for Jan. 26, 2021

Jan. 26, 2021
Biopharmas raising money in public or private financings, including: Ambulero, Bridgebio, Caladrius, Chimerix, Curevac, Cytomx, Inovio, Lipocine, Noxxon, Oncosec, Phio, Seelos, Tevogen, Vyne.
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Appointments and advancements for Jan. 26, 2021

Jan. 26, 2021
New hires and promotions in the biopharma industry, including: Accure, Amunix, Connect, Exact, Kronos, Nervgen, Taysha, Timber.
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