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Drug Development

All articles tagged with #drug development

AI Slashes Time and Costs in Late-Stage Cancer Trials, Tufts Finds
healthcare14 days ago

AI Slashes Time and Costs in Late-Stage Cancer Trials, Tufts Finds

Tufts’ Center for the Study of Drug Development finds Medable’s AI monitoring agent can speed up late-stage (phase 2/3) cancer drug trials by about 10 weeks and cut direct operating costs by up to $5.6 million, with larger net benefits as the drug targets more cancers (potentially up to $565 million for 50 indications). The technology could become standard in 3–5 years, aiding enrollment, data locking, and earlier safety assessments, while still facing challenges like patient recruitment, consent, drug distribution, and the need for human verification.

via Axios|
#ai#clinical-trials#cost-savings
Biotech Prediction Bets on Trials Prompt Ethical Backlash
technology19 days ago

Biotech Prediction Bets on Trials Prompt Ethical Backlash

Kalshi’s plan to let users bet on the outcomes of clinical trials has drawn sharp ethical objections from researchers and patients who warn such markets could undermine trial integrity and patient welfare, even as Kalshi argues bets would reflect updated evidence and cut through hype. The controversy highlights broader concerns about gamifying lifesaving research and treating trials as speculative bets, rather than purely scientific endeavors.

via Futurism|
#biotech#clinical-trials#drug-development
Columbia Researchers Trace Alzheimer's Origins Inside Brain Cells, Paving Way for New Drugs
health25 days ago

Columbia Researchers Trace Alzheimer's Origins Inside Brain Cells, Paving Way for New Drugs

Columbia University researchers at the Alzheimer's Research Center are pinpointing where Alzheimer's starts by studying the brain cell's endosome, using mouse models and postmortem human brains to test whether correcting this defect can rescue brain cell function, with plans to translate findings into drugs through academia–industry collaboration over the coming years.

via ABC7 New York|
#alzheimers-disease#columbia-university#drug-development
Pancreatic cancer braces for post-daraxonrasib era
biotech1 month ago

Pancreatic cancer braces for post-daraxonrasib era

At a European pancreatic cancer conference, experts hailed the anticipated launch of daraxonrasib as a potential milestone that could reshape care, echoing the impact of checkpoint inhibitors. But they warned the new therapy would bring opportunities and challenges—from access and pricing to real-world effectiveness and how it will be integrated into standard treatment and combination strategies as data emerge.

via STAT|
#biotech#clinical-trials#daraxonrasib
Antarctic Sea Toxins Could Fuel a New Melanoma Drug
science1 month ago

Antarctic Sea Toxins Could Fuel a New Melanoma Drug

USF researchers collected Antarctic ascidians (sea squirts) and found toxins they produce can kill melanoma cells in mice, suggesting potential for a new melanoma treatment. Developing a safe, human-approved drug will require extensive lab work, animal studies, and synthetic production, with ongoing NSF-funded collaborations to reproduce the toxin and move toward trials while addressing ecological and safety concerns.

via The Guardian|
#antarctica#drug-development#marine-biology
FDA launches pilot to speed up early drug trials and bolster U.S. competitiveness
health-policy2 months ago

FDA launches pilot to speed up early drug trials and bolster U.S. competitiveness

The FDA announced a pilot to accelerate early-stage clinical trials, aiming to cut development time by six to 12 months, boost U.S.-based trials, and counter China, while seeking congressional support to establish a permanent, faster Investigational New Drug pathway in the 2027 budget; the effort follows advocacy by former FDA Commissioner Marty Makary.

via statnews.com|
#clinical-trials#drug-development#fda
Measles Returns, Sparking a Race for Therapeutics
health2 months ago

Measles Returns, Sparking a Race for Therapeutics

As U.S. measles outbreaks rise due to declining vaccination rates, researchers and biotech firms are racing to develop an approved antiviral or treatment, though none exists yet; the resurgence highlights the ongoing health and economic costs of low vaccination coverage and has spurred renewed interest in antiviral strategies and potential therapies under investigation by scientists.

via The New York Times|
#antivirals#drug-development#health
BMS taps Anthropic to embed Claude Enterprise Across its global operations
business3 months ago

BMS taps Anthropic to embed Claude Enterprise Across its global operations

Bristol Myers Squibb announced a strategic agreement with Anthropic to deploy Claude across its research, development, manufacturing, commercial and corporate functions, empowering more than 30,000 employees with agentic AI. The rollout centers on Claude Code for engineering and will embed AI agents into priority workflows to accelerate target identification, trial documentation and regulatory submissions, and to speed manufacturing decisions, all while maintaining enterprise governance and secure integrations. This builds on BMS’s multi-year AI investments and a multi-vendor strategy to speed medicine discovery and delivery.

via Bristol Myers Squibb|
#anthropic#bristol-myers-squibb#business
Odyssey Therapeutics floats a $304M IPO to become a 'little large pharma'
business3 months ago

Odyssey Therapeutics floats a $304M IPO to become a 'little large pharma'

Odyssey Therapeutics priced a 15.5 million-share IPO at $18 to raise about $304 million (including a 1.4 million-share private placement with a TPG Life Sciences affiliate; the deal could grow by roughly $41.8 million if underwriters exercise the greenshoe). The proceeds will fund OD-001, a RIPK2 inhibitor for ulcerative colitis in phase 2, and move the preclinical SLC15A4 program into phase 1/2a, among other assets, as CEO Gary Glick pursues a 'little large pharma' model. Odyssey has raised about $726.5 million to date and will list on Nasdaq as ODTX.

via Fierce Biotech|
#biotech#business#drug-development
FDA drafts framework to validate human-centric NAMs, trimming animal testing in drug development
health-policy5 months ago

FDA drafts framework to validate human-centric NAMs, trimming animal testing in drug development

The FDA issued a draft guidance to help drug developers validate new approach methodologies (NAMs) as replacements for animal testing in drug development, outlining four core validation principles—context of use, human biological relevance, technical characterization, and fit-for-purpose—and encouraging early consultation with FDA review divisions. NAMs encompass advanced in vitro systems, organoids and organ-on-chip models, in silico methods, and even phylogenetically lower organisms like zebrafish. The goal is to rely on human-relevant data to improve safety predictions and accelerate access to safer therapies, building on previous efforts to reduce animal testing and update related guidance on pyrogen/endotoxin testing.

via fda.gov|
#animal-testing-alternatives#drug-development#fda-guidance