Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
By Don Tracy, Associate Editor JAMA study aims to determine whether financial barriers impact access to mental health services.In the United States, a number of low-income adults struggle to gain access to appropriate mental health care. Despite efforts such as new legislations aimed at extending both private and public insurance through the Affordable Care Act (ACA), financial barriers are still an issue. In a study published in JAMA Psychiatry, researchers aimed to discover whether there was an association between medical debt and delayed or forgone mental health care among adults in the United States. The study included data from the 2022 National Health Interview Survey, which measured responses from 27,651 adults with current or lifetime diagnoses of depression or anxiety. Additionally, Asian, Black, and Hispanic households were oversampled to improve precision of estimates for these groups. To provide accurate results, mental health status was assessed for depression and anxiety, measured ...
Mushroom gummies being sold to promote brain function may contain the illegal hallucinogen psylocibin and other harmful ingredients not listed on the label, UVA Health experts are warning after five people – including a 3-year-old child – were sickened. A spate of cases seen in UVA Health Medical Center’s emergency department between September and June prompted poison experts with UVA’s Blue Ridge Poison Center to test five different brands of the products sold in Central Virginia gas stations and smoke shops. Of those, three contained psilocybin or psilocin, substances classified as “Schedule I” drugs by the U.S. Food and Drug Administration, meaning they have no medical use and high potential for abuse. Psilocybin and psilocin are illegal at both the federal and state level. All the products tested claimed to contain the Amanita muscaria mushroom, which is legal, or a proprietary mushroom blend. But none disclosed the inclusion of psilocybin ...
In a Perspective, Daniel Drucker highlights the growing body of evidence that hints at the potential of glucagon-like peptide-1 (GLP-1)-based medications in treating conditions other than diabetes and obesity, including cardiovascular disease and neurodegenerative disorders. GLP-1 is a hormone released from the gut after eating that enhances glucose-dependent insulin secretion. Pharmacological GLP-1 receptor (GLP-1R) activation reduces glucagon secretion and slows gastric emptying, making it an effective treatment for type 2 diabetes. Later studies found that GLP-1 administration also inhibited food intake through GLP-1R activation in the brain, leading to their use in treating obesity. Recently, research has demonstrated that GLP-1 drugs produce additional health benefits beyond glucose and weight control, including reduced heart and kidney diseases. Here, Drucker discusses the potential mechanisms underlying these benefits, such as reducing systemic inflammation, and their implications for future clinical applications and drug development. According to Drucker et al., GLP-1 drugs have shown promise ...
By Mike Hollan The network includes organizations that represent over 45,000 agents and brokers. Industry leaders are taking steps to combat unauthorized plan switching in the Affordable Care Act (ACA) Marketplace. Unauthorized switching occurs when a user’s plan or agent of record is changed without their knowledge or consent. This is a form of fraud and can cause users to face unexpected costs, along with other consequences. Insurers across multiple states have joined together to form a network to prevent users from facing unauthorized switching.1 These insurers include BluCross BlueShield of North Carolina, Group Health Cooperative of South Central Wisconsin, Highmark BlueCross Blue Shield, and others. The network is named the Member Defense Network and it will launch in Florida in July, 2024. According to a press release, the network’s partners represent over 45,000 insurance agents and brokers. The cause of unauthorized switching has been a topic of debate. In ...
By Mike Hollan The tech company’s data platform will be implemented into the genomic research department’s workflow. Genomics research is growing in importance for the pharma industry with each passing year. One issue that researchers face, however, is the significant amount of data that genomics research generates and requires. Not surprisingly, recent advancements in data technology have caught the eye of many in the life sciences industry. Texas A&M Health and BurstIQ announced that they have formed a partnership which will leverage BurstIQ’s LifeGraph management platform to improve genomic data governance. The Texas A&M Health PROVENANCE clinicogenomics registry programs will be the primary benefactors of this partnership. In a press release, Texas A&M’s executive director of clinical, translational, and industry collaborations at the Institute of Biosciences and Technology, Center for Precision and Genomic Medicine Rick Silva, PhD, said, “LifeGraph provides a unique foundation for a modern, data-driven, and scalable approach ...
Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic small interfering RNA (siRNA) pipeline in clinical settings. The company will also use the investment proceeds to develop next-generation RNA platforms. LongRiver Investments spearheaded the financing round, which saw contributions from Zhaode Investment, Zhongqi Capital, BioTrack Capital and Lilly Asia Ventures. LongRiver Investments will become part of Rona’s board. The company focuses on developing siRNA programmes, with its first product, RN0191, having completed Phase I clinical studies in Australia and China. In December 2023, Rona received clinical trial application clearance from the National Medical Products Administration in China to assess RN0191 injection to treat hypercholesterolemia, mixed hyperlipidemia and atherosclerotic cardiovascular disease, to reduce the risk of cardiovascular events. The asset is set to enter Phase II clinical development for hypercholesterolemia. Rona’s second programme, RN0361, is scheduled to enter clinical trials in the second quarter of ...
The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for Pierre Fabre Pharmaceuticals’ Tabelecleucel (Tab-cel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). Tabelecleucel is being developed as a monotherapy for EBV+ PTLD treatment in adult and paediatric patients aged two years and above who have undergone a minimum of one previous therapy. It is an allogeneic, EBV-specific T-cell immunotherapy and acts on EBV-infected cells. The company’s BLA is supported by the outcomes of 430 subjects who received Tab-cel. For patients who have received solid organ transplants, previous therapy typically includes chemotherapy, except in cases where this is deemed inappropriate. No FDA-approved therapies are currently available for this treatment setting. A decision by the US regulator under the Prescription Drug User Fee Act (PDUFA) is anticipated by 15 January 2025. In November 2023, Pierre Fabre Laboratories obtained marketing rights to ...
Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region. Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how. Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US. An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI). Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections. CONTEPO’s new dosing approach aims to optimise the compound’s pharmacokinetics and pharmacodynamics. It met the primary endpoint in the ZEUS trial enrolling patients with cUTI. Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ...
The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) of Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals‘ vimseltinib to treat tenosynovial giant cell tumour (TGCT). Vimseltinib is a colony-stimulating factor 1 receptor (CSF1R). The review will be carried out under the centralised review process of the European regulator for all 27 member states of the European Union (EU), Iceland, Norway and Liechtenstein. The MAA filing is based on the findings of the Phase III MOTION clinical trial assessing the safety and efficacy of vimseltinib in people with TGCT not amenable to surgical procedure without previous anti-CSF1/CSF1R therapy, versus placebo. The study showed a significant objective response rate (ORR) at week 25 – the trial’s primary endpoint – compared to placebo. Secondary endpoints of the study included ORR per tumour volume score, active range of motion, physical function and quality of life assessments. Vimseltinib also showed a manageable ...
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