FDA approval of Biogen’s Aducanumab could change the Alzheimer’s treatment landscape
Biogen has completed the submission of a Biologics License Application (BLA) of its monoclonal antibody (mAb) aducanumab to the FDA…
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![ACE inhibitors; ARBs]()
ACE inhibitors, ARBs kindle interest to repurpose for Covid-19; potential risk apparent
by Manasi Vaidya in New York. Despite it being implicated in Covid-19, there is still equipoise on the role of…
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Increased visibility into patient-reported outcomes during clinical trials through FDA initiative: Project Patient Voice
On 23 June, the FDA, in collaboration with its Oncology Center of Excellence, launched an initiative, Project Patient Voice, designed…
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Virtual trials: welcome to the present
With Covid-19 delivering a great big slap in the face to ongoing and planned studies,...
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Clinical trial disruption due to Covid-19 has begun to decline
Since early March, around 1,000 organisations supporting clinical trials as the sponsor, collaborator, or contract research organisation (CRO) have publically…
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Why Asia-Pacific attracts 60% of all ongoing and planned hepatology trials globally
There are more than 1,300 clinical trials in hepatology, either ongoing or planned, in Asia-Pacific. This represents about 60% of…
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The impact of Covid-19 on the global clinical supply chain
It goes without saying that the coronavirus pandemic has had an unprecedented impact on economies...
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FDA may be risk-averse to grant emergency use for a Covid-19 vaccine; political pressure and hazy EUA standards are factors
by Reynald Castaneda in London, with additional reporting by Jennifer C Smith The FDA’s revocation of chloroquine and hydroxychloroquine’s Emergency…
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Covid-19 drug studies could highlight speed, flexibility and reduced risk of virtual clinical trials
After announcing a partnership to assess the safety of potential Covid-19 drugs, TRHC and Regence...
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Gilead’s remdesivir to commence Phase I trials as inhaled therapy to target mild Covid-19 patients
On 22 June, Gilead announced that it will begin Phase I clinical trials for inhaled remdesivir in healthy volunteers, and…
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