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CHMP backs approval of remdesivir as COVID-19 treatment pharmatimes
June 29, 2020
The EMA’s human medicines committee (CHMP) is backing approval of Gilead's remdesivir – under the brand name Veklury – for the treatment of COVID-19 in patients aged 12 years and over with pneumonia who require supplemental oxygen.
Eight medicines leap towards EU approval pharmatimes
June 29, 2020
The European Medicines Committee's human medicines committee (CHMP) has backed approval of eight new medicines across a range of indications.
Samsung Bioepis secures positive CHMP opinion for Aybintio pharmaceutical-technology
June 28, 2020
Korean biopharmaceutical firm Samsung Bioepis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Aybintio, a biosimilar to Avastin (bevacizumab).
Lynparza Recommended for Approval in EU by CHMP for BRCA-Mutated Metastatic Pancreatic Cancer americanpharmaceuticalreview
June 10, 2020
AstraZeneca and Merck announced Lynparza (olaparib) has been recommended for marketing authorization in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
Nabriva Receives Positive Opinion for XENLETA for Community-Acquired Pneumonia americanpharmaceuticalreview
June 09, 2020
Nabriva Therapeutics announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of XENLETA (lefamulin) for the treatment of community-acquired pneumonia..
EMA gives positive opinion to investigational Ebola vaccine regimen europeanpharmaceuticalreview
June 09, 2020
Developed by Janssen, the two-dose regimen has already been given to 60,000 patients and now has the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
EMA to assess conditional authorisation of first COVID-19 treatment in European Union expresspharma
June 09, 2020
The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted.
Lynparza backed by CHMP for BRCA-mutated pancreatic cancer pharmatimes
June 02, 2020
AstraZeneca and MSD's Lynparza (olaparib) has been recommended for marketing authorisation in the EU for the first-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
New vaccine for prevention of Ebola virus disease recommended for approval in the EU expresspharma
June 01, 2020
The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster.
Ranitidine Banned again after being Removed from the U.S. Market: Will a Chain Reaction be in China? PharmaSources/Laoxue
May 21, 2020
The Committee for Medicinal Products for Human Use (CHMP) under the EMA has recommended the suspension of all ranitidine drugs in the EU on Apr. 30.

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