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FDA gives Emergency Use Authorization for Nirmidas Biotech’s COVID-19 Rapid Antibody Fingerstick Test.

Nirmidas Biotech recently announced that the Food and Drug Administration (FDA) has given an Emergency Use Authorization (EUA) for their COVID-19 rapid antibody IgG/IgM test. 

The rapid test also known as MidaSpot COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test to detect antibodies against the COVID-19 virus. The test is easy to use, no instrument is needed, and gives results within 20 minutes. 

In their clinical studies of COVID-19 patients with fingerstick whole blood, the MidaSpot test showed 100% sensitivity for IgG after 14 days post symptom onset and 100% sensitivity for IgM after a week post symptom onset.

(Source: Business Wire, 2021)

Biocon receives $75,000 capital injection from ADQ. 

Biocon recently revealed that the company has received a capital injection of $75,000 from Abu Dhabi-based ADQ.                       

The transaction values the Biocon unit at $4.17 billion. Post the completion of this transaction, Biocon will hold an 89.89% stake in Biocon Biologics on a fully diluted basis.

As per the terms of the agreement, ADQ will invest $75,000  for a 1.80% minority stake in Biocon.     

Currently, Biocon has a wide spectrum of insulins in its product pipeline and the global scale needed to make a difference to diabetes patients all over the world.

(Source: Live Mint, 2021)

Y Biologics and 3D Medicines partners to develop novel cancer therapeutics in the Chinese market.

Y-Biologics and 3D Medicines have recently entered into a license agreement to develop, manufacture, and commercialize YBL-013 based on ALiCE platform technology in Greater China. 

Under the terms of their agreement, Y-Biologics will receive an upfront fee of $2 million and is eligible to receive up to $85 million in additional development, regulatory, commercialization, and sales milestone payments.

Meanwhile, 3D Medicines will have the exclusive rights to develop, manufacture, and commercialize for YBL-013 in Greater China, with potential expansion collaboration opportunities in the United States and other regions.

YBL-013 is a novel I/O therapeutic candidate that simultaneously targets CD3 on T cell and PD-L1 on a cancer cell, is the first candidate developed based on Y-Biologics’ proprietary T cell bispecific engager technology, namely ‘ALiCE’ (Antibody Like Cell Engager).

(Source: BioSpectrum Asia, 2021)