Clinical updates, including trial initiations, enrollment status and data readouts and publications: Avacta, Co-Diagnostics, Limacorporate, Medtronic, Phagenesis, Renalytix AI, Vivasure Medical.
LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials.
Keeping you up to date on recent developments in cardiology, including: PCI still the treatment of choice for COVID-positive STEMI patients; Utility of risk scores for TAVR patients questioned; Plaque similarly predictive in women and men.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Qorvo, Seigla.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acutus Medical, Hemanext, Lumiradx.
LONDON – The U.K. is moving on to the next phase of testing mixed dosing schedules for COVID-19 vaccines, launching a study in which it will assess the effect of using Moderna Inc. or Novavax Inc.’s products as the second dose in a heterologous prime boost trial.
LONDON – A large scale prospective study has shown that increased blood plasma viscosity is correlated with disease severity and the likelihood of progression to organ failure, in patients who are hospitalized with COVID-19 infections. Researchers at Addenbrooke’s Hospital in Cambridge, U.K. suggest this could be an easy but sensitive way to quickly triage patients admitted to hospital with symptoms of COVID-19.
