Respiratory syncytial virus, which puts millions of otherwise healthy infants in the hospital each year, could soon face a new foe. Top-line results from a phase III test of the extended half-life monoclonal antibody nirsevimab, developed by Astrazeneca plc and Sanofi SA, found it reduced lower respiratory tract infections requiring medical attention due to the virus in both healthy preterm and term infants.
One of the keys to making a schizophrenia drug work is reducing the side effects, which, if they are powerful enough, will often cause patients to cease the treatment. Laxminarayan Bhat, Reviva Pharmaceuticals Holdings Inc.’s CEO, told BioWorld that new phase II data of the company’s lead candidate shows the drop-out rate was low compared to other schizophrenia drugs.
Shares of Inovio Inc. (NASDAQ:INO) fell 25% to $6.85 on April 23 after the company said the U.S. Department of Defense scratched funding for the phase III portion of an ongoing trial of its COVID-19 vaccine candidate, INO-4800, in light of the broad availability of other COVID-19 vaccines in the U.S. The news followed recent phase I data showing '4800 performed about in line with already available competitors against SARS-CoV-2 variants now dominant in the U.S.
New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%. Symptomatic infections fell by 74% and infections with no reported symptoms by 57%, 21 days after receiving the first dose of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s vaccine.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arcutis, Arena, Avillion, Boehringer Ingelheim, Brickell, Bristol Myers Squibb, Eli Lilly, EMD Serona, Incyte, Janssen, Nicox, Novartis, Novavax, UCB, Verona.
TORONTO – Perimeter Medical Imaging Inc. has been awarded an FDA breakthrough device designation for a machine learning medical platform it said drives ultra-high-resolution, real-time imaging of breast cancer. Data collected from multiple pathology labs in Texas this past year were fed through the optical coherence tomography (OCT) imaging system which now is at the stage where its Imgassist artificial intelligence (AI)-based algorithms can be tested.
Atheart Medical Inc. came on the market with splash, simultaneously announcing the company’s formation and its launch of a U.S. investigational device exemption (IDE) trial for the Resept ASD occluder, a device designed to close atrial septal defects. Resept features a metal-free, bioresorbable frame to reduce the risks associated with the long-term presence of metal in the heart.
Advances lately in the genome-editing space include Beam Therapeutics Inc. publication in The CRISPR Journal details of its work with inlaid base editors, which the firm is applying in the BEAM-102 program for sickle cell disease. IBEs’ predictable, shifted editing window lets researchers go after disease-causing mutations that canonical base editors cannot reach, Beam said, and do the job with high efficiency and few off-target effects on the genome. The hottest news due in the near-term future from the sector will spill from Intellia Therapeutics Inc., of Cambridge, Mass., which is due to roll out first-in-human data with a systemic CRISPR-based genome editing therapy, NTLA-2001, in hereditary transthyretin amyloidosis.
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