Approvals

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Hympavzi, Pfizer's treatment for adults and adolescents with severe hemophilia A or B without inhibitors.

In a competitive immunology landscape, Eli Lilly is looking for novel agents, oral formulations of injectables, and combination therapies that can optimize response and expand the patient pool.

The European Medicines Agency is encouraging companies to submit the type I variations they want to make to their marketing authorizations by the end of this month.

Dual filings for Formycon’s aflibercept biosimilar have delivered results, with the Eylea rival endorsed under two names by the EMA’s CHMP.

Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.