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.
Koelis SAS reported the first successful procedures for its platform in 3D fusion imaging-guided focal ablation of prostate cancer at the Clinique Nantes Atlantis in Saint-Herblain, France. These first procedures take place against the background of a multicenter prospective clinical trial starting on the Koelis platform. This includes eight European urology centers, of which six are in France, with data being stored in a dedicated registry.
Chicago-based public benefit corporation Neopenda LLC secured the CE mark for its wireless, wearable vital signs monitor and picked up $1.4 million in new funding led by Assiduity Capital and the Sorenson Impact Foundation. The organization developed Neoguard to monitor critically ill infants in resource-poor regions, but adapted it last year to meet the monitoring needs of adult patients with COVID-19. The CE mark approval covers adult, pediatric and neonatal patients.
Lumicks BV raised $93 million in a series D financing led by new investors Farallon Capital Management and Lauxera Capital Partners. The proceeds are earmarked for expansion of the Lumicks’ product pipeline and for commercialization of its Z-Movi cell avidity analyzer.
Organoids cultured from patient-derived colorectal cancer cells have been used to demonstrate for the first time that tumors which have developed resistance to the full range of existing treatments, across chemotherapies, targeted therapies and immunotherapies, retain a requirement for Werner helicase (WRN) for survival. WRN has a key role in the maintenance of genome stability, but although loss of WRN is known to initiate synthetic lethality in DNA mismatch repair deficient colorectal cancer, studies into the effect of inhibiting that helicase have to date been limited to a handful of cell lines.
DUBLIN – The Biden administration’s proposals on global corporation tax reform have set alarm bells ringing across the Irish government, as officials digest the possible implications of the plan for Ireland's foreign direct investment model of economic development.
DUBLIN – A newly published retrospective analysis of the electronic health care records of more than 500,000 COVID-19 patients has found that infection with SARS-CoV-2 carries “a significantly and substantially” greater risk of cerebral venous thrombosis (CVT) than does either one of the two approved mRNA COVID-19 vaccines or infection with influenza virus.
PARIS – Roche SAS, the French division of Swiss pharmaceuticals manufacturer Roche Holding AG, has signed a partnership with Unicancer that brings together all the cancer centers in France. They have created Oncodatahub (ODH), the first real-world cancer data platform in France. This makes a set of quality, longitudinal data representative of cancer patient care in France available to all those involved in the health care ecosystem.
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.
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