Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer.
Astrazeneca plc and Ionis Pharmaceuticals Inc. have unveiled some eye-catching figures from their cholesterol drug, AZD-8233, in a phase IIb trial, taking aim at the PCSK9 inhibitor market where Novartis AG, Sanofi SA/Regeneron Inc. and Amgen Inc. are vying for supremacy.
Preclinical data on two newly designed mRNA molecules from Sunshine Biopharma Inc., of Montreal, showed they are effective at killing cancer cells grown in culture. Tests were performed on a variety of cancer cells, including multidrug-resistant breast cancer cells, ovarian adenocarcinoma cells and pancreatic cancer cells, while toxicology studies using normal human cells showed that the mRNA molecules had little or no cytotoxic effects.
Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
The fortunes of Protalix Biotherapeutics Inc. improved dramatically with phase III results from the Fabry disease study called Balance, and a resubmission of the BLA for pegunigalsidase alfa (PRX–102) is planned for the second half of this year. In February, an MAA for PRX-102 was submitted to the EMA.
Shares in Pharming Group NV were up after the company announced detailed data from its phase II/III trial of leniolisib for the rare disease activated phosphoinositide 3-kinase delta (PI3K-delta) syndrome (APDS).
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
With the Russian invasion of Ukraine continuing to disrupt thousands of clinical trials throughout the region, the European Commission, the EMA and the Heads of Medicines Agencies are developing advice to help sponsors mitigate the issues.
Clovis Oncology Inc. is trying to claw its way into ovarian cancer relevance against vastly larger competitors Astrazeneca plc and Glaxosmithkline plc with positive top-line phase III data from its study of PARP inhibitor Rubraca (rucaparib). The study’s monotherapy arm of Rubraca as a first-line maintenance treatment of ovarian cancer hit the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared to placebo. The median PFS was 20.2 months for Rubraca compared to 9.2 months for placebo in the intent-to-treat group.
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