Phesi COVID-19 study indicates obesity a major complicating factor
The virtual clinical development firm’s analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.
Archives for June 7, 2021
FDA approves Biogen’s Alzheimer's drug, Aduhelm
The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.
Moderna applies to expand COVID-19 vaccine authorization to adolescents
Moderna has applied to expand use of its COVID-19 vaccine to adolescents in the EU: and also plans to submit an application for emergency use authorization (EUA) for this age group in the US.
Bluebird's gene therapy trials to resume after FDA clearance
The FDA has lifted the clinical holds on bluebird bio’s trials of gene therapies in sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), an inherited blood disorder.
Eliminating Variables Is Central to Kitting Design
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Flexibility has become a necessity in clinical trials. The trend of decentralization is a significant change for the industry and has grown increasingly common. While certain treatment or assessment visits still need to occur at the investigators’...
ADC developer, Iksuda Therapeutics, closes $47m financing round
UK-based biotechnology company, Iksuda Therapeutics, has completed a US$47m (£34m) financing round, which was led by Mirae Asset financial group and included a strategic investment from Korean biopharma player, Celltrion.
Notes on compliance: USP 60 compliance doesn’t have to be complicated
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When United States Pharmacopeia 60 (USP 60) came into effect little more than a year ago, it added a new dimension to testing for objectionable organisms in pharmaceutical products. The regulation, which was triggered by a string of Burkholderia...