“Now it’s all about time to market,” Bavarian Nordic A/S CEO Paul Chaplin said as the company disclosed positive results from the phase IIa study with its respiratory syncytial virus (RSV) vaccine, MVA-BN RSV. “We’re looking at designs [for phase III] that give us the fastest approval possible” in the competitive space, he said, adding that the previously envisioned two-season setup “has gone out the window” with the latest findings.
LONDON – One in seven children and young people who have COVID-19 go on to develop symptoms of Long COVID, according to the first cut of data from a large national study involving 6,804 participants ages 11 to 17 who had PCR tests between January and March this year.
The race to develop better antivirals for COVID-19 is heating up after Pfizer Inc. and Merck & Co. Inc. pushed ahead with clinical development of late-stage candidates, while Rigel Pharmaceuticals Inc. announced encouraging midstage data.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Adial, Amarin, Axerovision, Bayer, Curevac, Genentech, Gennova, Gensight, GSK, HDT, J&J, Nocion, Pharmaxis, Poseida, Roche, Senhwa, SK Bioscience, Tauriga.
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation.
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA.
Recently published phase II data with Takeda Pharmaceutical Co. Ltd.’s TAK-906 (trazpiroben), a dopamine D2/D3 receptor antagonist, fueled hope for patients as Processa Pharmaceuticals Inc. proceeds with a different – and more focused – approach against gastroparesis.
Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
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