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WuXi ATU opens manufacturing facility in Shanghai to enhance its CTDMO services
Biotech | October 22, 2021

WuXi ATU opens manufacturing facility in Shanghai to enhance its CTDMO services

It’s the company’s fourth manufacturing site worldwide. Others are located in the US, UK and China


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Ivenix selects Eastman Tritan copolyester for its new infusion system
Medical Device | October 21, 2021

Ivenix selects Eastman Tritan copolyester for its new infusion system

Ivenix selected Tritan MXF for the pump exterior because of its excellent chemical resistance and durability in the face of the aggressive disinfection protocols needed to prevent the spread of healthcare-associated infections


FDA approves Cyltezo, the first interchangeable biosimilar to Humira
Drug Approval | October 20, 2021

FDA approves Cyltezo, the first interchangeable biosimilar to Humira

Second interchangeable biosimilar product approved by agency


WHO to take call on Covaxin's EUL on October 26th
News | October 18, 2021

WHO to take call on Covaxin's EUL on October 26th

The WHO chief scientist Soumya Swaminathan tweeted on Oct. 17


U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer
Drug Approval | October 18, 2021

U.S. FDA approves Roche’s Tecentriq as adjuvant treatment for small cell lung cancer

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting


Imfinzi plus tremelimumab significantly improved overall survival in liver cancer
Biotech | October 18, 2021

Imfinzi plus tremelimumab significantly improved overall survival in liver cancer

The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib


Lancet Respiratory Medicine publishes Phase 2 data of Medigen Covid-19 vaccine
News | October 16, 2021

Lancet Respiratory Medicine publishes Phase 2 data of Medigen Covid-19 vaccine

The interim analysis showed that the MVC-COV1901 vaccine has a good safety profile and elicits promising neutralising antibody titres