Healthcare Roundup – Lilly/Innovent rituximab injection OK’d in China; BioNTech, Pfizer announce rolling submission for COVID-19 vaccine candidate

Published on: October 9, 2020
Author: Amy Liu

Lilly/Innovent rituximab injection OK’d in China

Eli Lilly (NYSE:LLY) and Innovent Biologics (OTCPK:IVBIY) jointly announce that HALPRYZA has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China.

HALPRYZA (rituximab injection) is a recombinant human/murine chimeric monoclonal antibody drug.

BioNTech, Pfizer announce rolling submission for COVID-19 vaccine candidate in Canada

BioNTech (BNTX +1.1%) and Pfizer (PFE -0.5%) have initiated a rolling submission to Health Canada seeking approval of lead COVID-19 vaccine candidate BNT162b2.

This rolling review, will allow Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.

Recently, both companies commenced rolling submission for COVID-19 vaccine candidate in Europe.

OPKO Health’s BioReference Labs launches COVID-19 testing program for NYC schools

OPKO Health’s (NASDAQ:OPK) unit BioReference Laboratories has commenced its COVID-19 testing program for New York City schools throughout the 2020-2021 school year.

Under a collaboration with New York City, the Department of Health, New York City Health & Hospital, the Test & Trace, and the Department of Education, BioReference will be performing COVID-19 molecular testing for NYC schools, as well as collect specimens from principals, teachers, administration and students from 950+ schools across the city.

Update: Shares up 2% premarket on modest volume.

FDA OKs emergency use of new Beckman coronavirus antibody test

The FDA grants emergency use authorization to Danaher (NYSE:DHR) unit Beckman Coulter’s Access SARS-CoV-2 Immunoglobulin M (IgM) assay (the body first produces IgM antibodies in response to an infectious pathogen so it is an indicator of recent infection).

The company says the test boasts 98.3% sensitivity (correctly identifying true positives) and 99.9% specificity (correctly identifying true negatives).

The Access IgG (antibodies produced after IgM) assay was approved in June for emergency use in the U.S. during the pandemic.

Both tests can be performed on the company’s automated high-throughput instrumentation.

Sorrento holder registers nearly 1M shares

Sorrento Therapeutics (NASDAQ:SRNE) files an S-3 registering up to 996.8K shares that may or may not be offered for sale by a Selling Shareholder at some point.

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