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FDA Accepts sNDA with Priority Review for FETROJA americanpharmaceuticalreview
June 11, 2020
Shionogi announced the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA? (cefiderocol) and granted Priority Review designation ...
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..
Merck’s sNDA for RECARBRIO Wins FDA Approval contractpharma
June 08, 2020
For the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by Gram-negative microorganisms.
Interim analysis indicates Auxora? is effective in severe COVID-19 pneumonia patients europeanpharmaceuticalreview
June 05, 2020
Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone.
FDA approves Merck’s antibiotic drug to treat hospital-acquired bacterial pneumonia expresspharma
June 05, 2020
The US Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
Roche to begin Covid-19 pneumonia trial with Actemra/RoActemra plus remdesivir pharmaceutical-business-review
June 02, 2020
Roche has announced the commencement of phase III clinical study of Actemra/RoActemra plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.
Roche Initiates Phase III Trial in COVID-19 Pneumonia contractpharma
May 29, 2020
To evaluate Actemra/RoActemra plus remdesivir in hospitalized patients with severe Pneumonia.
Marinomed receives FFG funding to research SARS-CoV-2 therapy based on carragelose expresspharma
April 29, 2020
Available clinical data show that Carragelose binds previously known coronaviruses and other viruses that trigger respiratory infections.
Vanda Initiates Study of Tradipitant in Hospitalized Patients with Severe COVID-19 Pneumonia americanpharmaceuticalreview
April 08, 2020
Vanda Pharmaceuticals announced the initiation of clinical study, ODYSSEY VLY-686-3501, in hospitalized patients with COVID-19.
Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia worldpharmanews
March 23, 2020
Roche is working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration ...