Tags : EU’s Approval

Regulatory

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment

Shots: The approval is based on P-lll ETHOS involve the assessing of Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) vs Bevespi Aerosphere and PT009 in adult patients with mod. to sev. COPD. P-III KRONOS study also supported the approval The study showed a reduction in rate of mod. or sev. exacerbations. EMA’s CHMP has recommended the MAA […]Read More

Regulatory

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to

Shots: The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs. The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and […]Read More

Clinical Trials

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Shots: The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and […]Read More