All articles by Vishnu Priyan

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.

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.