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BioWorld - Friday, January 9, 2026
Home » Topics » Coronavirus, BioWorld

Coronavirus, BioWorld
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Regulatory actions for Oct. 7, 2020

Oct. 7, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Arca, Arch, Biomarin, Eton, Lilly, OWP, Pluristem, Polarean, TLC, Y-Mabs.
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Other news to note for Oct. 7, 2020

Oct. 7, 2020
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aetion, Anpac, Bintai Kinden, Biogen, Calithera, Citius, Complix, Denali, Foundation, Generex, Greenwich, Innovent, Kindred, Lilly, Mapi, Novellus, Nugenerex, Olix, Provention, Renibus, Spartina, Sunovion, Sunshine, Théa, UCB, Urovant, Vaccibody, Vaxart.
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In the clinic for Oct. 7, 2020

Oct. 7, 2020
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Abfero, Achieve, BMS, Epizyme, Ilya, Immunitybio, Lilly, Nantkwest, Napo, Onconano, Pfizer, Redhill, Stoke, Teva.
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Jeff Shuren
Virtual Medtech Conference

FDA’s Shuren pounds on inadequacy of statute in CDRH town hall

Oct. 6, 2020
By Mark McCarty
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology.
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Drug vials and syringe

FDA delivers on promise of guidance for vaccine EUAs

Oct. 6, 2020
By Mari Serebrov
Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.
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Kiniksa shares rise on phase II GCA readout

Oct. 6, 2020
By Michael Fitzhugh
New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo.
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Japanese shield and coronavirus

Astrazeneca resumes AZD-1222 trials in Japan

Oct. 6, 2020
By Gina Lee
HONG KONG – Cambridge, U.K.-based Astrazeneca plc has resumed phase I/II trials in Japan for AZD-1222, the experimental, adenovirus vector-based candidate coronavirus vaccine that it is co-developing with the University of Oxford.
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Handshake with cityscape and businesspeople

Q3 sets stage for record-hitting deals; M&As to pick up in fourth quarter

Oct. 6, 2020
By Karen Carey
Just as financings are hitting record levels, biopharma deals should finish out 2020 on top, based on solid partnerships signed in the first three quarters of the year. While mergers and acquisitions have slowed this year, particularly in the third quarter, several big-money M&As slated to close in the fourth quarter could move the needle, putting this year within the top three highest values.
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Regulatory actions for Oct. 6, 2020

Oct. 6, 2020
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegle, Amag, Amphastar, Biogen, Biontech, Curtana, Glycomimetics, Huya, Iovance, Oncternal, Oragenics, Pfizer, Samsung, Y-mabs.
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Regulatory front

Study puts the numbers to U.S. insulin prices

Oct. 6, 2020
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: FDA’s PRV fees drop again; PMDA offering early COVID-19 vaccine advice; NICE, SIGN go long on COVID-19.
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