LONDON – The U.K. has set up the first randomized controlled trial of COVID-19 vaccines in pregnant women, to assess different dosing schedules. The aim is to find the balance between longer intervals that are known to spur a greater immune response, against shorter intervals that provide faster protection.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Biogen, Biophytis, Cytokinetics, Flugen, Humanigen, Ionis, Moderna, Novartis, Prometheus, Servier, Zentalis.
LONDON – More than six years after the technical specification was agreed, the EMA clinical trial information system (CTIS) has cleared the final hurdle and can go live in January 2022, after notice of approval was published in the EU Official Journal on Saturday July 31. The approval, following an independent audit of the system, was the spur for the EMA to intensify the training program it is putting in place for trial sponsors and national regulators, to ensure CTIS’ successful implementation.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Astrazeneca, Beigene, Biogen, Cyclo, Enyo, Lilly, Optinose, RDIF, Vaxart.
Annovis Bio Inc. presented new clinical efficacy and biomarker data from two phase II studies of its lead candidate, ANVS-401 (posiphen), at the 2021 Alzheimer's Association International Conference (AAIC) that saw the stock sink soon afterward. The Berwyn, Pa.-based company’s shares (NYSE:ANVS) took a powerful hit as shares had plunged a dramatic 60% to close at $43.50 each on July 29.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Arca, Ascletis, Astrazeneca, Clarity, Disc, Eccogene, Enyo, Hutchmed, Karyopharm, Kintor, Mersana, Mind Medicine, Zucara, Zymeworks.
Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Biogen, Cerecor, Effector, Eisai, Entasis, Grunenthal, Infinity, Merck, Redx, Relmada, Xylocor.
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