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At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
TALZENNA® is the first PARP inhibitor approved in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC) in the EU.
A $5.9 billion acquisition of biotech Iveric Bio by Astellas is set to accelerate development of treatments for blinding retinal diseases.
Xtandi reduced the risk of death by 34 percent in men with metastatic hormone sensitive prostate cancer in a Phase III study.
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-300x278.jpg)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-e1617017465349.jpg)
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
The Chinese National Medical Products Administration has given its approval to XTANDI® to treat prostate cancer, following a successful Phase III trial.
XTANDI® sNDA seeks to add an indication for men with prostate cancer that's spread but is sensitive to hormone therapy.
Amgen and Astellas Pharma US have agreed to pay a total of $124.75 million to settle allegations that they paid kickbacks to Medicare copays for their own medications.
7 March 2016 | By Victoria White
The Scottish Medicines Consortium (SMC) has accepted three new medicines for routine use in NHS Scotland.
