Europe

AELIS FARMA, a biotechnology company specialized in the treatment of brain disorders, announces the completion of a €11 million financing round from the Region Nouvelle Aquitaine, Inserm Transfert Initiative, Bpifrance and the ACI, NACO and Aelis Innovation regional funds.
Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, is presenting a scientific poster assessing acute care involving chemotherapy-induced nausea and vomiting amongst breast cancer patients receiving various treatments for CINV prophylaxis including NEPA, at the San Antonio Breast Cancer Symposium.
If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for newly diagnosed patients who are eligible for a stem cell transplant in six years
Positive Opinion is based on data from the Phase 3 TITAN study which were published in The New England Journal of Medicine
PharmaMar shall receive an upfront payment and is eligible for additional remunerations, including regulatory milestone payments.
CELLINK’s goal is to grow sales organically with a minimum of 35% per year and grow additionally through acquisitions.
Horizon Discovery Group plc, a global leader in the application of gene editing and gene modulation technologies, announces a strategic collaboration with Mammoth Biosciences, that will see the two companies develop new CRISPR tools to provide the next generation of engineered cell lines for the biopharmaceutical industry.
FDA
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
The two trials were evaluating the drug for reducing the rate of moderate-to-severe exacerbations compared to placebo over a 52-week period for inadequately controlled moderate-to-severe asthma (GINA Steps 4 and 5).
Study fails to meet primary endpoint of overall response rate in patients whose tumors express low-to-no PD-L1
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