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AstraZeneca announced on Saturday that it has resumed its phase 3 COVID-19 vaccine trial in the UK after pausing it last Tuesday due to a single “unexplained illness.” Read More
Refocusing new drug R&D to a more patient-centric approach, an using new technology alongside soft skills like empathy and collaboration, are among the changes the pharmaceutical industry can expect in coming years. Read More
The abuse-deterrent formulation of Purdue Pharma’s OxyContin (oxycodone Hcl) does have some benefit in reducing abuse of the opioid medication, a joint meeting of two FDA advisory committees decided in three separate votes on Friday. Read More
TSC has shown in preclinical models to increase oxygen availability and provide functional benefit for acute lung injury and hemorrhagic shock. Read More
The National Institutes of Health (NIH) launched two phase 3 trials yesterday, evaluating different types of blood thinners to treat COVID-19 patients. Read More
As long as a safety review of an AstraZeneca COVID-19 trial that’s been paused due to an illness allows the trial to resume, the drugmaker expects to stay on track and submit its vaccine candidate for regulatory approval by the end of the year. Read More
A second government agency, the Biomedical Advanced Research and Development Authority (BARDA), is now scrutinizing contracts awarded to Moderna, examining whether the vaccine maker failed to disclose millions of dollars it got in federally funded awards in several patents and patent applications the firm has filed for its vaccines. Read More
Reports “are incorrect” that a participant in AstraZeneca’s COVID-19 vaccine trial that was paused Tuesday suffered from transverse myelitis, an AstraZeneca spokesperson told FDAnews Wednesday. Read More
AbbVie has signed a collaboration agreement with Chinese biotech I-Mab to develop and commercialize, lemzoparlimab (TJC4), I-Mab’s monoclonal antibody under development for multiple cancers. Read More
AstraZeneca has paused a late-stage trial of its promising COVID-19 vaccine candidate while it evaluates a single UK patient who may have experienced a serious adverse reaction. Read More