All articles by Vishnu Priyan
FDA grants approval for Gilead’s multi-drug resistant HIV-1 treatment
A long-acting HIV capsid inhibitor, Sunlenca is intended for dosing twice a year.
Lilly and ProQR to expand genetic medicine development agreement
Lilly will make an upfront payment and equity investment totalling $75m to ProQR under the latest agreement.
Merck and Kelun-Biotech enter ADC development deal
Kelun-Biotech is entitled to get payments of up to $9.3bn on meeting development, regulatory and sales milestones from Merck.
Moderna and UK government sign deal to establish mRNA facility
The centre is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses.
EC approves Sobi-ADC’s Zynlonta for diffuse large B-cell lymphoma
With the approval, Zynlonta can be used in all member states of the European Union, Norway, Liechtenstein and Iceland.
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US FDA grants approval for Radius’ Tymlos for osteoporosis in men
This approval is based on findings from the multicentre, double-blind, 12-month Phase III ATOM clinical trial.
Japan approves BMS’ Breyanzi for large B-cell lymphoma
The approval is based on trial findings in subjects with r/r aggressive B-cell non-Hodgkin lymphoma following first-line therapy.
Sanofi and Innate Pharma extend cancer therapeutics partnership
Innate is eligible to receive a total of up to $1.43bn in preclinical, clinical, regulatory and commercial milestone payments.
FDA grants approval for AbbVie’s major depressive disorder therapy
Cariprazine is a once-a-day oral atypical antipsychotic developed by AbbVie and Gedeon Richter.
EMA CHMP recommends Moderna’s Covid-19 booster for children
A Phase II/III trial of mRNA-1273.214 as a booster and initial regimen in children aged six months to five years is progressing.