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RSS FeedPosted by Michael Wonder on 08 Jun 2020
U.K. lab to sidestep pharma industry to sell potential virus vaccine
7 June 2020 - Imperial College aims to develop a vaccine that is cheaper and easier to manufacture and is forming ...
Posted by Michael Wonder on 08 Jun 2020
The quest for a vaccine could restore faith in big pharma
4 June 2020 - The boffins of AstraZeneca are showing the way forward ...
Posted by Michael Wonder on 07 Jun 2020
The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate
5 June 2020 - A vaccine is anticipated to be available in 2021 if clinical trials are successful. ...
Posted by Michael Wonder on 07 Jun 2020
Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure
5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
Posted by Michael Wonder on 07 Jun 2020
Lilly bags expanded EU approval for Taltz
5 June 2020 - The European Medicines Agency has expanded the reach of Lilly's Taltz (ixekizumab) to include the treatment ...
Posted by Michael Wonder on 06 Jun 2020
AiCuris was granted breakthrough therapy designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients
5 June 2020 - AiCuris is currently preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 ...
Posted by Michael Wonder on 05 Jun 2020
Genmab announces European marketing authorisation for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of patients with multiple myeloma
4 June 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies. ...
Posted by Michael Wonder on 04 Jun 2020
FDA re-evaluates user fees for biosimilar reviews
4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...
Posted by Michael Wonder on 04 Jun 2020
Trump Administration selects five coronavirus vaccine candidates as finalists
3 June 2020 - The Trump administration has selected five companies, including Moderna, AstraZeneca and Pfizer, as the most likely ...
Posted by Michael Wonder on 04 Jun 2020
The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs
4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...
Posted by Michael Wonder on 04 Jun 2020
Adamas announces FDA filing acceptance of sNDA to modify the indication statement for Gocovri to include treatment for Parkinson’s disease patients receiving levodopa and experiencing OFF episodes
4 June 2020 - Adamas Pharmaceuticals today announced that its supplemental new drug application for Gocovri as a treatment for OFF ...
Posted by Michael Wonder on 04 Jun 2020
FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
4 June 2020 - Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat ...
Posted by Michael Wonder on 04 Jun 2020
U.S. FDA accepts Pharmaessentia's application for ropeginterferon alfa-2b to treat polycythemia vera
4 June 2020 - U.S. team begins commercial preparations for novel pegylated interferon with appointment of General Manager Meredith Manning. ...
Posted by Michael Wonder on 04 Jun 2020
TVAX Biomedical receives fast track designation from the FDA for brain cancer
4 June 2020 - TVAX Biomedical announced today receipt of fast track designation from the U.S. FDA for the use of ...
Posted by Michael Wonder on 04 Jun 2020
Patients’ and health care professionals’ organisations updated on EMA’s response to COVID-19
4 June 2020 - EMA updated patients’ and healthcare professionals’ organisations about its COVID-19 activities. ...