BioBiz: Bristol-Myers Squibb and Sanofi ordered to pay for Plavix warning label; Bluebird Bio suspends gene therapy trials; Thermo Fisher snags EUA for COVID-19 test; and other news

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Bristol-Myers Squibb and Sanofi were ordered to pay Hawaii $834 million over Plavix warning label. A judge in Hawaii on Monday ordered Bristol-Myers Squibb Co and Sanofi SA to pay more than $834 million to the state for failing to warn non-white patients properly of health risks from its blood thinner Plavix. Judge Dean Ochiai in Honolulu concluded the companies engaged in unfair and deceptive business practices from 1998 to 2010 by failing to change the drug’s label to warn doctors and patients despite knowing some of the risks.

Bluebird Bio has placed its Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease (SCD) (bb1111) on a temporary suspension due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).

In line with the clinical study protocols for HGB-206 and HGB-210, bluebird bio placed the studies on temporary suspension following a report received last week that a patient who was treated more than five years ago in Group A of HGB-206 was diagnosed with AML. The company is investigating the cause of this patient’s AML in order to determine if there is any relationship to the use of BB305 lentiviral vector in the manufacture of LentiGlobin gene therapy for SCD. In addition, a second SUSAR of myelodysplastic syndrome (MDS) in a patient from Group C of HGB-206 was reported last week to the company and is currently being investigated.

Thermo Fisher Scientific has obtained Emergency Use Authorization from the US Food and Drug Administration for a multiplex real-time PCR test for COVID-19 and influenza. The Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit can detect and differentiate RNA from SARS-CoV-2, influenza A, and influenza B viruses using nasopharyngeal or nasal swab samples.

The kit includes the Applied Biosystems Pathogen Interpretive Software, which converts genetic analysis data into a report. Use of the kit is limited to laboratories that are CLIA-certified to perform high-complexity tests and to similarly qualified non-US laboratories.

Sesen Bio, a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, said that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

Cytovia Therapeutics, Inc. and Cellectis announced today that they have entered into a strategic research and development collaboration to develop TALEN® gene-edited iPSC NK and CAR-NK cells.  The financial terms of the partnership include up to $760 million of development, regulatory, and sales milestones from Cytovia to Cellectis for the first 5 TALEN® gene-edited iPSC-derived NK products. Cellectis will also receive single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia. Cellectis will receive an equity stake of $15 million in Cytovia stock or an upfront cash payment of $15 million if certain conditions are not met by December 31, 2021, as well as an option to invest in future financing rounds. Cellectis will develop custom TALEN®, which Cytovia will use to edit iPSCs.