Reports of two patient deaths prompted Celyad Oncology SA to voluntarily pause a phase Ib trial testing its allogeneic CAR T-cell therapy, CYAD-101, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with refractory metastatic colorectal cancer (mCRC), the latest safety hitch among efforts to advance the promise of CAR T beyond the first approvals in hematological malignancies.
For years, a vaccine against respiratory syncytial virus (RSV) has been out of reach. But this could change thanks to several candidates in the late-stage pharma pipeline. Among them, Moderna Inc. became one of the front-runners in the race to develop a vaccine for the virus after this week announcing that its entrant in the contest, mRNA-1345, is moving into phase III development.
PERTH, Australia – Prota Therapeutics Ltd.’s lead candidate PRT-120 induced clinical remission of peanut allergy in 51% of children in a phase IIb clinical trial. There are currently no curative therapies to treat food allergies, Prota Therapeutics CEO Mimi Tang told BioWorld. Peanut allergy in children can be particularly problematic because the only treatment is avoidance.
Kodiak Sciences Inc. shares (NASDAQ:KOD) closed at $9.86, down $40.49, or 80.42% after the firm unveiled top-line data from its randomized, double-masked, active comparator-controlled phase IIb/III trial testing KSI-301, an antibody biopolymer conjugate, in treatment-naïve subjects with wet age-related macular degeneration (AMD).
In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.
Jubilant Therapeutics Inc. started 2022 with an IND clearance for JBI-802, its oral, selective dual inhibitor of lysine-specific demethylase 1 (LSD1) and HDAC6, setting up a year that could be important for LSD1 in the hands of others as well.
Shares in Synairgen plc have cratered after a phase III trial of its inhaled COVID-19 therapy SNG-001 failed to produce conclusive results, with the company blaming improvements in standard care for the disappointing findings in patients hospitalized with the disease. The Southampton, U.K.-based biotech’s shares (LSE:SNG) touched lows of 10 pence, down 94%, and stabilized around 85% below their previous closing price of £25.36 after the announcement on Monday.
Livzon Pharmaceutical Group Inc.’s key interim data from the phase III trials of its recombinant SARS-CoV-2 fusion protein vaccine, V-01, has shown efficacy against the omicron variant. The phase III trial aims to evaluate the efficacy, safety and immunogenicity of V-01 as a booster in adults older than 18 after they have received two doses of inactivated vaccines.
Phase III data are due any day from Ascendis Pharma A/S, and Wall Street’s thoughts have turned to hypoparathyroidism (HPT), an indication fraught with questions in recent years.
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