ChemoCentryx/Vifor Change Tack On EU Avacopan Filing
ChemoCentryx and Vifor Fresenius have changed their conditional marketing authorization application for avacopan to a full MAA in the EU after it emerged that data from the ADVOCATE study will be more comprehensive than expected.
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Switzerland’s leader in iron deficiency therapies wants to add new products in this and adjacent therapeutic areas, as strong revenue growth in 2018 backs its strategy of concentrating its efforts on the pharmaceuticals business.
No New Patients For Lartruvo In EU After Trial Failure
The EMA says that in light of the disappointing results of the ANNOUNCE trial, no new treatments should be initiated with Lilly’s Lartruvo in patients with soft tissue sarcoma. This is the first time the agency has taken action such as this on a product that has received a conditional marketing authorization.
International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.