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ASU drug manufacturing licence goes online
Policy | October 09, 2021

ASU drug manufacturing licence goes online

The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence


Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation
Biotech | October 09, 2021

Roche’s Alzheimer antibody granted U.S. FDA Breakthrough Therapy Designation

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022


Tezepelumab granted Orphan Drug Designation in the US
Biotech | October 09, 2021

Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)


Sanofi says positive results from flu vaccine with mRNA booster study
Biotech | October 08, 2021

Sanofi says positive results from flu vaccine with mRNA booster study

The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older


CDSCO approves Syntellix implants
News | October 08, 2021

CDSCO approves Syntellix implants

This opens up a huge market for the company’s Magnezis implants in India


Lilac Insights launches mental health platform AtEase
Healthcare | October 08, 2021

Lilac Insights launches mental health platform AtEase

The platform will provide a safe and nurturing space for women, and non-binary individuals


Janssen announces novel mechanism that shows promise against dengue
Biotech | October 07, 2021

Janssen announces novel mechanism that shows promise against dengue

Early-stage research suggests the potential to prevent and treat all dengue serotypes and builds on Johnson & Johnson's work to advance science against emerging and entrenched global public health threats


U.S. FDA clears Venclose Maven to treat incompetent perforator veins
Medical Device | October 07, 2021

U.S. FDA clears Venclose Maven to treat incompetent perforator veins

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years


Thermo Fisher Scientific introduces On the Go mobile app in India
Digitisation | October 07, 2021

Thermo Fisher Scientific introduces On the Go mobile app in India

The applications navigate through more than 100 workflows across biotech, pharma, healthcare, food, forensics, industrial and applied sciences industries