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Results For "antibody"

448 News Found

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


Piramal Pharma Solutions commissions ADC manufacturing expansion in Scotland
News | December 21, 2023

Piramal Pharma Solutions commissions ADC manufacturing expansion in Scotland

The commissioning of the facility represents the culmination of a £45m investment to address rapidly growing demand for ADC manufacturing, supported by a £2.4m Scottish Enterprise grant


European Commission approves Pfizer’s Elrexfio for multiple myeloma
Drug Approval | December 09, 2023

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial


Aragen setting up a US$ 30 million bio-manufacturing site in Bengaluru
Biotech | October 31, 2023

Aragen setting up a US$ 30 million bio-manufacturing site in Bengaluru

Biologics manufacturing to expand the Aragen platform by offering “gene to GMP” solution


Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19
News | October 30, 2023

Pfizer and BioNTech announce data for mRNA-based vaccine program for influenza and COVID-19

The companies plan to start a pivotal Phase 3 trial in the coming months


Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer
Drug Approval | October 26, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients


Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs
News | October 20, 2023

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months


Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma
Drug Approval | August 16, 2023

Pfizer receives USFDA approval for Elrexfio for the treatment of relapsed or refractory multiple myeloma

ELREXFIO’s label contains a boxed warning for cytokine release syndrome and neurologic toxicity


Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin
News | July 22, 2023

Lonza delivers 5.6% CER sales growth and 30% CORE EBITDA margin

Good momentum in commercial CDMO business


Lonza launches new cell culture media system TheraPRO
News | July 18, 2023

Lonza launches new cell culture media system TheraPRO

The two-part production system is proven to yield high-quality proteins from GS-CHO cell lines, a prevalent mammalian host cell for protein production