It was a good day for Novartis: A second drug with huge selling potential has been approved for the US market. The FDA gave the go ahead for breast cancer drug Piqray (alpelisib), the first and only treatment developed specifically for patients with a PIK3CA mutation in HR+/HER2-advanced breast cancer.
The FDA has approved Novartis-subsidiary AveXis Inc’s spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi). The company wants to set the price tag at $2,125m per dose.
At BioEquity 2019, Spanish Bioindustry Association ASEBIO has given a sneak peek into its 2018 Annual Report, that each year describes the news and trends from the Spanish Biotech Sector.
Chiesi Farmaceutici has licenced commercialiation rights for LHON treatment Raxone (idebenone) from Santhera Pharmaceuticals for CHF50m (44m) in cash plus sales milestones.
Evotec SE is set to acquire biologics manufacturing specialist Just Biotherapeutics, Inc in a deal that could amount up to $90m.
Researchers at German regulatory authority Paul-Ehrlich Institute (PEI) have patented a method to accurately forecast biotech-based protein synthesis in host cells.
In an oversubscribed Series B round led by LSP, Paris-based DNA Script raised US$38.5. Bpifrance and existing investors Illumina Ventures, M. Ventures, Sofinnova Partners, Kurma Partners and Idinvest Partners contributed.
Researchers from Universities Nijmegen and Naples have presented a retinal AAV-based gene therapy delivery system that can express huge genetic elements by assembling protein fragments from several vectors.
Molecular diagnostics company Mobidiag has received an EIB loan to accelerate the development and commercialisation of its in vitro diagnostic solutions for infectious diseases.
Privately financed Italian antibody-cytokine fusion protein specialist Philogen SpA has secured 62m from private investors including the Neri and Dompé families to push registration of two wholly owned Phase III products.