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At FDA, ‘caretaker mode’ is better than power trip mode

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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?

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Ebola cases increase almost 40% in a week as death toll passes 200

DAKAR, Senegal — The Ebola outbreak in Congo and Uganda has claimed more than 200 lives in its first month and is the worst known outbreak at this stage, with up to 35,000 suspected potential contacts, Africa’s Centres for Disease Control and Prevention said on Thursday.

With 894 confirmed cases so far, the current outbreak is three times worse than a previous outbreak in Uganda in 2000, which had 281 cases at the same point, said Dr. Wessam Mankoula, a medical epidemiologist at Africa CDC.

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DAKAR, Senegal — The Ebola outbreak in Congo and Uganda has claimed more than 200 lives in its first month and is the worst known outbreak at this stage, with up to 35,000 suspected potential contacts, Africa’s Centres for Disease Control and Prevention said on Thursday.

With 894 confirmed cases so far, the current outbreak is three times worse than a previous outbreak in Uganda in 2000, which had 281 cases at the same point, said Dr. Wessam Mankoula, a medical epidemiologist at Africa CDC.

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IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings

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IDBS, which provides cloud software for biopharma, and Alchemi, an applied AI company, partnered to connect AI agents to data captured and contextualized in the IDBS Polar platform across the drug development lifecycle. By capturing such data at the point of creation within a single governed backbone, Polar delivers the data foundation that makes agentic AI viable in regulated environments, explains IDBS in a statement.

Preparing regulatory filings remains one of biopharma’s most persistent bottlenecks. CMC teams spend months assembling data, drafting reports, and reconstructing process histories, while current AI tools often break the compliance chain by pulling data out of validated systems, according to an IDBS spokesperson, adding that connecting Alchemi’s purpose-built agents to Polar’s AI-ready data foundation keeps validated data traceable and auditable.

CMC technical reports, clinical study reports, and submission dossiers can be drafted faster and routed through human-in-the-loop workflows for review and sign-off, maintaining compliance, points out the IDBS official. According to Alchemi, in customer deployments across biopharma, teams have produced documents of this type up to 70% faster using Alchemi’s agents.

“A regulatory filing that takes a team weeks, our agents draft in minutes, at submission-ready quality, with the compliance trail intact, because they work straight from governed data in Polar,” reports Anuj Chadha, co-founder, Alchemi.

“Our mission is to accelerate life-changing therapies to patients, and as part of Danaher, that means turning ideas into impact with speed and certainty,” says Pietro Forgione, general manager, IDBS. “[Our company] delivers a governed data backbone that makes AI-ready data available across the biopharma lifecycle. By partnering with Alchemi, we can accelerate critical regulatory milestones using high-quality, compliant AI agents,” said Pietro Forgione, general manager, IDBS.

The post IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings appeared first on GEN – Genetic Engineering and Biotechnology News.

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cAMPfield lands $180M to build gut disease drug

The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.

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The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.

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