Archimedes Pharma

Business Insights

Athira Pharma, Inc. | October 18, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The committee also determined that, with the additional enrollment of fewer than 150 patien...

Business Insights

Commonwealth Informatics, a Genpact company | January 25, 2022

Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom. MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Comm...

Pharma Tech

Astellas Pharma Inc. | September 30, 2022

Astellas Pharma Inc. announced the European Medicines Agency has accepted for regulatory review the company's marketing authorization application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 "More than half of women 40 to 64 years of age ex...

Political News - POLITICO | February 07, 2020

Lawmakers are raising concerns anew about the U.S. reliance on foreign drug manufacturing amid the Wuhan coronavirus outbreak that has pushed FDA inspectors out of China. The novel disease outbreak could spark medical product shortages if the epidemic is not resolved swiftly, experts say. The challenges come as Chinese drug manufacturing has been in Congress's spotlight following a series of warnings last year about contaminated batches of foreign-made drugs. “There is emerging and I t...