FarmaKology-AI Identifies Patients at Risk of Diabetes
Prospection is a Pioneer in healthcare data analytics. Using predictive analytics and machine learning with real world healthcare data to unearth insights that help research, develop and target better healthcare outcomes for patients. Founded out of Sydney’s Cicada Innovations in 2012, Prospection works with government, pharmaceutical companies and the medical community across more than 70 therapy programs, including immuno-oncology, HIV and hepatitis.
Algernon Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for Ifenprodil for the Treatment of Idiopathic Pulmonary Fibrosis
Algernon Pharmaceuticals Inc., a Canadian clinical stage pharmaceutical development company, is pleased to announce that the United States Food and Drug Administration (“U.S. FDA”) has granted Orphan Drug Designation (ODD) to Ifenprodil as a treatment for Idiopathic Pulmonary Fibrosis (IPF). Ifenprodil is the sole active ingredient in NP-120, an NMDA receptor antagonist and the Company’s lead clinical candidate being developed for the treatment of IPF and chronic cough.
European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
Biogen Inc. announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of tofersen, an investigational drug for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). SOD1-ALS is a progressive and uniformly fatal disease that affects less than 1,000 people in Europe. There is currently no treatment targeted for SOD1-ALS.
Novartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancer
Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI1. No unexpected safety findings were observed in PSMAfore; data are consistent with the already-well established safety profile of Pluvicto.
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years
Pfizer Inc. and BioNTech SE today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.
Research & Study
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