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Becton, Dickinson and Company

https://www.bd.com/en-us

Latest From Becton, Dickinson and Company

From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots

Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.

Coronavirus COVID-19 Vaccines

Novartis, Takeda See Industry Better Prepared For Next Pandemic

Novartis and Takeda’s R&D efforts saw an impact from the COVID-19 pandemic, but both Lutz Hegemann and Andrew Plump believe that when the next pandemic hits, the industry and regulators will be better prepared for it.

Coronavirus COVID-19 Commercial

J&J's COVID-19 Vaccine May Face Efficacy Comparison Questions At US FDA Panel Review

Efficacy against moderate to severe/critical COVID-19 was 66%-67%, well above the FDA’s stated 50% efficacy threshold for an EUA but far short of the 94%+ efficacy rates posted by the Pfizer and Moderna vaccines against symptomatic disease; agency says efficacy against specific variants cannot be evaluated at this time because sequencing data are incomplete.

Advisory Committees Vaccines

Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space

More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.

Clinical Trials Advisory Committees
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    • BD
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    • Caesarea Medical Electronics
    • CareFusion
    • Carmel Pharma, Inc.
    • Carmel Pharma, AB
    • Cellular Research, Inc.
    • C.R. Bard, Inc.
    • CRISI Medical Systems
    • Davol, Inc.
    • Embo Medical Limited
    • FlowCardia, Inc.
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    • Sirigen Group Limited
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    • Rochester Medical, Inc.
    • Safety Syringes Inc.
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