Sanofi and Ad Scientiam have partnered to launch an international, multicentre, longitudinal study to evaluate the ability of medical software, MSCopilot, to assess disability progression in people with multiple sclerosis (MS). The main objective of the MS-DETECT study, which explores digital biomarkers of MS, is to determine whether the MSCopilot software can effectively identify subtle and early signs of disability worsening. MS is a chronic immune-mediated, neurodegenerative disease of the central nervous system that currently affects 2.8 million people globally. The study will include 314 people with MS and will be conducted in the US, Canada, Germany, Italy, Spain, Denmark and France. Coordinating investigator and chairman of the study steering committee, professor Patrick Vermersch, believes that “these novel digital biomarkers are key to helping clinicians make appropriate treatment decisions and, ultimately, improve patients’ care.” As part of the agreement, the study will draw upon Ad Scientiam’s expertise in MS and ...
Monkeypox (mpox) is a zoonotic disease caused by the mpox virus (MPXV) that has been primarily limited to Central and West African nations since its discovery. The recent spread of the West African lineage of MPXV in historically unaffected countries has raised concerns for global public health. Despite a significant decrease in global mpox cases, there is still a risk of a global resurgence. This study reports the first local case of mpox caused by an imported case in the Chinese mainland. Polymerase chain reaction (PCR) diagnosed the two cases, and the viral genomes were obtained by next-generation sequencing. Genomic analysis revealed that the two strains shared an identical genome sequence and belonged to the B.1.3 branch of the West African lineage, which is the first local case of mpox caused by an imported case in the Chinese mainland, highlighting the potential threat of mpox in China and the immediate ...
Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
By Jamie Gumbrecht, CNN CNN — The FDA sent warnings letters to eight companies for marketing and manufacturing of unapproved eye products. Sarah Silbiger/Getty Images The US Food and Drug Administration on Monday sent warning letters to CVS, Walgreens and other companies over manufacturing and marketing of unapproved eye products the agency says could pose a risk to people who use them. The agency said the products are illegally marketed to treat conditions including conjunctivitis — pink eye — glaucoma and cataracts, and some of the warnings cited sterility issues with the products. The agency issued warning letters to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc. Some companies have also been placed on import alert to stop products from entering the United States. “The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic ...
By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
Charles River Laboratories International has signed a multi-programme collaboration agreement with Related Sciences (RS) for the artificial intelligence (AI)-powered drug platform, Logica. Last year, Charles River and Valo Health unveiled Logica, a solution that leverages the AI-powered Valo Opal Computational Platform, along with Charles River’s preclinical expertise. Logica will be used on multiple previously undrugged targets within the RS portfolio. RS will collaborate with the teams from both Charles River and Valo Health to deploy Logica to discover significant new medicines. These medicines will be used to meet unmet requirements across disease areas including autoimmunity, cancer immunotherapy and inflammatory diseases. Charles River senior vice-president and chief scientific officer Julie Frearson stated: “Logica’s unique platform, which combines AI/machine learning (ML)-enabled in silico discovery, high-powered DNA-encoded libraries and traditional screening techniques, has the capability to accelerate the drug discovery and development pipeline, transforming a target to a candidate in just over two ...
US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
First Wave BioPharma has acquired Sanofi’s capeserod with plans to repurpose it as a gastrointestinal (GI) disease therapy. Following the news, First Wave’s stock skyrocketed by over 80% in pre-market trading. The US-based company has a market cap of $3.112m. The agreement includes a $500,000 upfront payment, with developmental and commercial milestone payments of up to $46m and $235m, respectively. Additionally, Sanofi would have the right of first refusal on any capeserod sublicensing agreement and would be entitled to a percentage of any licensing payments. Sanofi also reserves the first refusal right to reacquire capeserod during development. Capeserod is a selective partial agonist of the serotonin type 4 (5-HT4) receptor. In the GI tract, these receptors perform various functions, including gastric emptying, decreasing oesophageal reflux, and promoting intestinal peristalsis. Sanofi had previously evaluated capeserod in Alzheimer’s disease and urinary incontinence but had since terminated the drug development. However, Fist Wave ...
Moderna and Immatics have announced a collaboration agreement aimed at developing ‘novel and innovative’ cancer therapies, with the deal potentially worth over $1.7bn. The multi-platform partnership will combine Moderna’s mRNA technology with Immatics’s T-cell receptor platform and cover various therapeutic modalities such as bispecifics, cell therapies and cancer vaccines. The companies outlined in a statement that their research will focus on three main pillars, including applying the mRNA technology for in vivo expression of Immatics’s half-life extended TCR bispecifics (TCER) targeting cancer-specific HLA-presented peptides. They will also leverage Moderna’s mRNA experience alongside Immatics’s tumour and normal tissue data included in its Xpresident target discovery platform and Xcube bioinformatics and AI platform to develop mRNA-based cancer vaccines, as well as evaluate Immatics’s IMA203 TCR-T therapy targeting preferentially expressed antigen in melanoma (PRAME) in combination with Moderna’s investigational PRAME mRNA-based cancer vaccine. Under the terms of the agreement, Immatics will receive an ...
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