The Daily Biotech Pulse: FDA Wants Omicron-Targeted COVID-19 Boosters, Provention Bio Clears Hits Hurdle For Diabetes Prevention Drug, Oxford Biomedica, AstraZeneca Strike Vaccine Pact


Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

FDA Expert Panel Favors COVID-19 Boosters Targeting Omicron BA.4, BA.5 Subvariants

The FDA's independent experts voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.

The panel has advised manufacturers to develop modified vaccines that add an omicron BA.4/5 spike protein component to the vaccine composition to create a two-component (bivalent) booster vaccine.

Genmab Plans To File US Application For Epcoritamab In Blood Cancer Setting

Genmab A/S (NASDAQ: GMAB) plans to submit a marketing application to the FDA for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for relapsed/refractory large B-cell lymphoma, in 2H of 2022.

The planned submission is supported by results from the large b-cell lymphoma cohort of the pivotal EPCORE NHL-1 open-label, multicenter trial.

FDA Extends Decision Date For Provention Bio's Lead Product Candidate 

The FDA has extended the review period by three months for Provention Bio Inc's (NASDAQ: PRVB) marketing application for teplizumab to November 17.

Teplizumab is under review for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk …

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