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Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Lonza to establish manufacturing facility in Guangzhou, China
News | August 25, 2021

Lonza to establish manufacturing facility in Guangzhou, China

The investment will establish drug product manufacturing capacity for clinical trial and commercial supply in China and offer customers combined drug substance and drug product manufacturing services


Covid-19 severity screening method developed
Digitisation | August 23, 2021

Covid-19 severity screening method developed

Researchers from IIT Bombay and QIMR Berghofer Medical Research Institute, Australia have developed this method, based on the Agilent Cary 630 FTIR Spectrometer


Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study
Biotech | August 19, 2021

Second-Gen mRNA COVID-19 vaccine candidate CV2CoV show positive signs in preclinical study

The preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone


FDA grants Emergency Use Authorization for next-generation Covid-19 assays
Digitisation | August 19, 2021

FDA grants Emergency Use Authorization for next-generation Covid-19 assays

Thermo Fisher’s kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes Covid-19


Novartis secures new approval in China for Cosentyx in pediatric psoriasis
Drug Approval | August 18, 2021

Novartis secures new approval in China for Cosentyx in pediatric psoriasis

Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions and with more than 500,000 patients treated worldwide since launch