Ocugen: FDA Lifts Hold on Covid-19 Vaccine Candidate Study
May 23 2022 - 7:30AM
Dow Jones News
By Colin Kellaher
Ocugen Inc. on Monday said the U.S. Food and Drug Administration
lifted the clinical hold on a Phase 2/3 study of the biotechnology
company's Covaxin Covid-19 vaccine candidate.
The Malvern, Pa., company said it plans to resume study dosing
immediately.
Ocugen in April said the FDA had placed the hold on the study
after the company paused dosing while it evaluated statements made
by the World Health Organization following an inspection of
manufacturing plant in India owned by Bharat Biotech International
Ltd., Ocugen's partner on the vaccine.
The WHO identified certain good-manufacturing-practice
deficiencies. Ocugen in April said it would work with the FDA to
address any questions.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 23, 2022 07:15 ET (11:15 GMT)
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