Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antengene, Bioinvent, Can-Fite, CG, Checkmate, Henlius, Iliad, Mediwound, Novartis, Summit, Targovax, Viridian.
Everest Medicines Ltd. and Providence Therapeutics Holdings Inc.’s COVID-19 vaccine was cleared for inclusion in the World Health Organization’s (WHO) Solidarity Trial Vaccines clinical trial.
Antibiotics continue to take a beating as top-line results from Summit Therapeutics Inc.’s phase III study of ridinilazole failed to meet the primary endpoint for sustained clinical response and treating C. difficile infection (CDI). Looking for an upside on its lead candidate’s results, the company noted participants treated with ridinilazole had substantially less recurrence of CDI, the most common cause of diarrhea in hospitalized patients, as compared to those who were administered vancomycin (nominal p-value = 0.0002).
A recently published study demonstrated that Viome Life Science Inc.’s metatranscriptomic signature for oral cancer identified the malignancy from samples of saliva with more than 90% accuracy. The mRNA platform received breakthrough device designation from the FDA in May for both early-stage oral squamous cell carcinoma and oropharyngeal cancer.
Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis.
Wall Street didn’t much like Uniqure NV’s decision to hold off reporting efficacy measures in the phase I/II trial with one-time gene therapy AMT-130 for the treatment of Huntington’s disease (HD), but safety findings proved encouraging and analysts held out hope.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
Vaccine specialists Sanofi SA and Glaxosmithkline plc have been behind the curve throughout the pandemic, with upstarts such as Moderna Inc. and Biontech SE stealing the show with their ground-breaking mRNA technology. While their rivals were beginning to launch the first wave of vaccines early last year, Sanofi and GSK had to reformulate theirs after it failed to produce a strong enough immune response in older people. New results show that the shot, SP-0253, could play a role as a booster but there will be another delay after the companies struggled to recruit enough participants in a crucial phase III trial.
RSS
