The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective. The FDA expects the new advisory committee will become fully operational in 2024. It will discuss technologies such as artificial intelligence and machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software. In addition, topics covered by this new committee could include decentralized clinical trials, patient-generated health data, and cybersecurity. The committee will consist of a core nine voting members, including the chair. Members serve terms of up ...
As artificial intelligence (AI) hovers between a “buzz phrase” and marveled reality, many point to the potential the technology has in the pharma industry. While some criticize the rate at which pharma uptakes new technologies and implements them into their processes, the industry must also strike a fine balance with moving cautiously when it comes to changes due to the nature of the industry and the potential impact on patients those changes can bring. But it can’t be denied that there is a plethora of data in every part of the process of drug creation and distribution that needs to be more efficiently managed and utilized—from preclinical and R&D to manufacturing to commercialization and distribution. But perhaps one of the greatest appeals of AI is the potential it has for innovation. Andrew Hopkins, founder and CEO of Exscientia, an AI-driven precision medicine company founded in 2012, shares in this Q&A ...
Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
Collaboration based on Valo’s large human dataset and computation powered by artificial intelligence. Image Credit: Adobe Stock Images/Shutter2U Novo Nordisk and Valo Health revealed that they have struck a deal to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). According to Novo Nordisk, this will include access to real-world patient data, AI-enabled small molecule discovery and Biowire human tissue modeling platform designed to speed up the discovery and development process. As per terms of the deal, Valo will receive an upfront payment and a potential near-term milestone payment of $60 million, with the potential to earn additional milestone payments up to $2.7 billion, plus R&D funding and potential royalty payments. “Artificial Intelligence and machine learning hold the promise to positively impact drug discovery and development, in particular enabling our vision of leveraging human datasets early in the ...
Novo Nordisk has announced that it has entered into a partnership with Valo Health, worth up to $60m, to discover and develop new treatments for cardiometabolic diseases. The collaboration aims to utilise Valo’s Opal Computational Platform and real-world patient dataset, as well as its artificial intelligence (AI)-enabled small molecule discovery and its human tissue modelling platform, Biowire, to accelerate discovery and development. The Opal Computational Platform is an integrated, end-to-end drug discovery and development platform that is designed to enable a fully integrated and efficient approach for targeting and advancing candidates to regulatory approval. As part of the agreement, Valo will receive an upfront payment and a potential near-term milestone payment of $60m, as well as milestone payments for up to 11 programmes totalling up to $2.7 billion, plus research and development funding and potential royalty payments, said Novo Nordisk. Valo will enable the identification and validation of novel druggable ...
German group Merck has announced two new drug discovery collaborations with BenevolentAI and Exscientia to harness artificial intelligence (AI)-driven design and discovery capabilities to accelerate drug discovery. The partnerships are expected to generate several new clinical development drug candidates in key therapeutic areas of oncology, neurology and immunology. Under the terms of the agreements, three potential targets have been selected to initiate each partnership, with the potential of identifying and nominating additional targets in the future. The collaborations will focus on advancing small-molecule development candidates, which Merck will select for further preclinical and clinical development. As part of the agreements, both UK-based companies will receive upfront payments from Merck and will be eligible for future milestone payments plus tiered royalties based on net sales. Exscientia will receive an upfront payment of $20m and up to $674m in milestone payments if all three projects meet their objectives. Meanwhile, BenevolentAI is set ...
The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
Merck KGaA has announced two new strategic partnerships with Benevolent AI and Exscientia to support its artificial intelligence (AI)-driven drug discovery plans. Benevolent and Exscientia plan to leverage Merck KGaA’s expertise in oncology and neuroinflammation under the collaboration. As part of the agreement, the companies have collectively selected three potential first-in-class and best-in-class targets. The partnership will focus on finding viable small molecule candidates for development that Merck KGaA will choose for further preclinical and clinical development. In this deal, announced on 20 September, BenevolentAI will be eligible for payments of up to $594 million, including a low double-digit million-dollar immediate payment. Further payments will be made according to future discovery, development and commercial milestones. Also, the London, UK-based company could receive tiered royalties on net sales of any commercialised products. BenevolentAI is already collaborating with AstraZeneca and Eli Lilly for AI-driven drug discovery. In May, BenevolentAI announced intentions to ...
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