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U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


Glenmark’s PMS study allays concerns on use of Favipiravir for Covid-19 treatment
News | September 15, 2021

Glenmark’s PMS study allays concerns on use of Favipiravir for Covid-19 treatment

These were the findings of the Post Marketing Surveillance (PMS), study of Favipiravir (FabiFlu) on over 1000 patients


ICMR to use drones for vaccine delivery
Supply Chain | September 14, 2021

ICMR to use drones for vaccine delivery

ICMR receives conditional exemption from Drone Rules 2021 to speed up vaccine delivery in the A&N Islands, Manipur and Nagaland


US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test


Laurus Labs, Unitaid and Clinton Health Access Initiative to develop HIV medication for children
Public Health | September 14, 2021

Laurus Labs, Unitaid and Clinton Health Access Initiative to develop HIV medication for children

Laurus will be incentivised for a portion of its development and commercialisation costs. CHAI will also provide technical and regulatory support to enable accelerated generic development


BDR Pharmaceuticals launch Cabozantinib to treat thyroid cancer
Drug Approval | September 14, 2021

BDR Pharmaceuticals launch Cabozantinib to treat thyroid cancer

In several trials like Celestial (double-blind phase III trial), Phase III Meteor trials, Cabozantinib has shown better PFS (Progression-Free Survival).


Boehringer Ingelheim and Twist Bioscience ink antibody discovery collaboration
News | September 13, 2021

Boehringer Ingelheim and Twist Bioscience ink antibody discovery collaboration

Research collaboration covers multiple antibody research programs


Zydus Cadila seeks approval for a two-dose ZyCoV-D Covid-19 vaccine
News | September 13, 2021

Zydus Cadila seeks approval for a two-dose ZyCoV-D Covid-19 vaccine

The three-dose vaccine approved for EUA contains 2mg for each dose, whereas the two-dose plan will have 3mg in each dose.


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


Zydus Cadila gets US FDA approval for antidepressant tablets
Drug Approval | September 09, 2021

Zydus Cadila gets US FDA approval for antidepressant tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.