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BioWorld - Friday, May 15, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Oct. 18, 2021

Oct. 18, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Histosonics, Thermo Fisher Scientific.
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Valneva vaccine vials

Regulatory submissions ahead on solid phase III data for Valneva’s COVID-19 vaccine

Oct. 18, 2021
By Nuala Moran
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.
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In the clinic for Oct. 18, 2021

Oct. 18, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Astrazeneca, Eli Lilly, Medigen, Merck, Protalix, RDIF, TG.
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Alinity m system

Abbott Alinity tests for COVID subject of class I recall

Oct. 15, 2021
By Mark McCarty
The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best.
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Regulatory actions for Oct. 15, 2021

Oct. 15, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cepheid.
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Other news to note for Oct. 15, 2021

Oct. 15, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andau Medical, Detect, Ganymed Robotics, Milestone Scientific, New Al Farwaniya Surgicals and Medical Equipment, Pathai, Roche, Sanolabor.
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Other news to note for Oct. 15, 2021

Oct. 15, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biothera, Pharmapark, Shortwave, Treadwell, Vaxil and Xortx.
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Janssen COVID-19 vaccine vial

FDA adcom unanimously supports a booster for Janssen’s COVID-19 vaccine

Oct. 15, 2021
By Lee Landenberger
The FDA’s Vaccines and Related Biological Products Advisory Committee unanimously agreed to recommend a booster dose of Janssen Biotech Inc.’s COVID-19 vaccine for those age 18 years and older at least two months following the first dose. In the end, the vote swung on numbers from Janssen showing a booster significantly improved efficacy among study participants. Janssen’s data leaped to 94% protection after a booster dose, up from 70% efficacy following the first dose. That higher efficacy rate nearly matches that of the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE.
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Hands holding gears

BIA Autumn Forum: Keep collaboration, innovation momentum post-pandemic, new UK science minister urges

Oct. 14, 2021
By Nuala Moran
LONDON – After the hard, solitary slog through months of pandemic, U.K. biotech finally convened in person, buoyed by the contribution the sector has made to dealing with COVID-19, and evidently pleased to be face-to-face once more.
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Moderna COVID-19 vaccine

Unanimous booster vote more a desire to avoid confusion

Oct. 14, 2021
By Mari Serebrov
Given the FDA’s Vaccines and Related Biological Products Advisory Committee’s unanimous vote last month to recommend use of a booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine in certain high-risk groups, it came as no surprise when the committee again voted unanimously Oct. 14 for a mirror use of Moderna Inc.’s proposed booster.
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