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PTA-News: NAVSTONE SE: Positive Geschäftsentwicklung im ersten Halbjahr 2021

PTA-News: NAVSTONE SE: Positive Geschäftsentwicklung im ersten Halbjahr 2021
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Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease

Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Nirsevimab PhII/III trial confirms safety profile

  and tolerability profile in infants at high risk of RSV     The MEDLEY Phase II/III trial evaluated the safety and tolerability of nirsevimab compared to Synagis (palivizumab) when given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season. 1   The trial assessed the safety of nirsevimab in infants with chronic lung disease (CLD), congenital heart disease (CHD) and/or prematurity. Occurrence of treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) were similar between groups. 1   Nirsevimab is a long-acting antibody, using AstraZeneca s proprietary YTE technology, being developed by AstraZeneca and Sanofi with the potential

Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Forxiga recommended in EU for patients with CKD

  for the treatment of patients with chronic kidney disease   for millions of people in the EU suffering from chronic kidney disease   AstraZeneca s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).   The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo.

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