Tag Archives: European Commission approval

EMA Supports AstraZeneca’s Eco-Friendly Trixeo Aerosphere for COPD with Ultra-Low Emission Propellant

(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release

European Commission approves Conexxence and Bomyntra denosumab biosimilars from Fresenius Kabi for all reference indications, boosting access and the #FutureFresenius Biopharma agenda

(IN BRIEF) The European Commission has approved Fresenius Kabi’s denosumab biosimilars, Conexxence® and Bomyntra®, for all uses of the originator product. These include osteoporosis treatment for postmenopausal women and at-risk men, mitigation of treatment-related bone loss, prevention of skeletal complications … Read the full press release

AstraZeneca’s Calquence Combination Therapy Approved for Untreated CLL in Europe Following Positive AMPLIFY Phase III Results

(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release

SSAB received EC approval to sell 50% of the shares in Norsk Stål AS (Norway) to Leif Hübert AS

STOCKHOLM, 9-2-2015 — /EuropaWire/ —  SSAB has received approval from the European Commission to sell 50% of the shares in Norsk Stål AS (Norway) to Leif Hübert AS. This transaction is part of the divestment remedies that the European Commission … Read the full press release