A healthy ecosystem supporting research and development of new anti-infectives is emerging with the considerable help of government efforts to address the threats of spreading antimicrobial resistance.
Anti-Infective R&D Ecosystem Getting Healthier, But Trials Remain
FDA and other government agencies have successfully nurtured a healthy ecosystem to rebuild the antibiotics pipeline, and a new crop of antibiotics has now reached the pivotal stage of clinical trials. But the sponsors are largely small companies: can they survive in the highly constrained commercial market for serious infections?
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EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
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DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
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Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.
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The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.