NLS Pharma Business

European regulators have validated Chiesi's submissions for two next-generation propellant inhalers, part of the biopharma company's shift toward lower-carbon respiratory products.

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer — the first new regimen in more than ten years for this patient group.

Uppsala-based Readily Diagnostics has received a grant of approximately USD 970,000 (about SEK 9 million) from the Gates Foundation to develop a low-cost point-of-care test for chlamydia, gonorrhea and trichomoniasis, aimed at low-resource settings.

Lytix Biopharma has received FDA feedback on its proposed registrational Phase III trial design for ruxotemitide (LTX-315) in patients with resectable high-risk melanoma, with no objections raised – removing a key source of regulatory uncertainty as the company seeks a partner to fund and run the study.

The company has received an indicative offer for all shares in the company.

EMA has decided to grant  Orphan Drug Designation (ODD) for OXC-201 for idiopathic pulmonary fibrosis (IPF).