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RSS FeedPosted by Michael Wonder on 18 Apr 2020
NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
17 April 2020 - The National Institutes of Health (NIH) and the Foundation for the NIH are bringing together more than ...
Posted by Michael Wonder on 18 Apr 2020
Finding effective treatments for COVID-19: scientific integrity and public confidence in a time of crisis
16 April 2020 - Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). ...
Posted by Michael Wonder on 17 Apr 2020
FDA approves first targeted treatment for patients with cholangiocarcinoma, a cancer of bile ducts
17 April 2020 - Today, the U.S. FDA granted accelerated approval to Pemazyre (pemigatinib), the first treatment approved for adults with ...
Posted by Michael Wonder on 17 Apr 2020
FDA approves first new drug under international collaboration, a treatment option for patients with HER2-positive metastatic breast cancer
17 April 2020 - Today, as part of Project Orbis, the U.S. FDA approved Tukysa (tucatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 17 Apr 2020
Chi-Med announces surufatinib granted U.S. FDA fast track designations for the treatment of both pancreatic and non-pancreatic neuroendocrine tumours
17 April 2020 - Hutchison China MediTech today announces that the U.S. FDA has granted two fast track designations for the ...
Posted by Michael Wonder on 17 Apr 2020
The coronavirus is mutating. What does that mean for a vaccine?
16 April 2020 - Around the world, hope for a return to normalcy is pinned on a vaccine, the “ultimate ...
Posted by Michael Wonder on 17 Apr 2020
Health Canada approves an extended indication for Kisqali (ribociclib) in combination treatment
16 April 2020 - Breast cancer is the most common female cancer in Canada. ...
Posted by Michael Wonder on 17 Apr 2020
FDA accepts for priority review biologics license application for REGN-EB3 to treat Ebola
16 April 2020 - REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy. ...
Posted by Michael Wonder on 16 Apr 2020
Provention Bio initiates rolling submission of biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
16 April 2020 - Rolling submission initiated under breakthrough therapy designation. ...
Posted by Michael Wonder on 16 Apr 2020
Japan, China vie to be global supplier of unproven coronavirus drug
16 April 2020 - Diplomatic tug of war over favipiravir comes despite lack of evidence that the drug works. ...
Posted by Michael Wonder on 16 Apr 2020
Can the world find a good COVID-19 vaccine quickly enough?
16 April 2020 - And can it mass produce it fairly if it does? ...
Posted by Michael Wonder on 16 Apr 2020
Bayer's chloroquine donation to U.S. raises concern about FDA standards in pandemic
16 April 2020 - On March 21, two days after President Donald Trump first touted chloroquine drugs as a “game ...
Posted by Michael Wonder on 16 Apr 2020
EMA shares advice on validated computer systems used in clinical trials
16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...
Posted by Michael Wonder on 16 Apr 2020
COVID-19 update: FDA continues user-fee related reviews
16 April 2020 - The U.S. FDA's User Fee programs help us fulfil our mission to protect public health while ...
Posted by Michael Wonder on 16 Apr 2020
Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data
16 April 2020 - Observational studies of data generated in clinical practice in the context of COVID-19 can contribute to the ...