Single CRISPR infusion cuts stubborn LDL cholesterol for a year
A single dose of CTX310, a CRISPR-Cas9 therapy, dropped LDL cholesterol by more than half in patients who did not respond to standard drugs. The effect lasted at least a year.
Clinical trial 10 articles
In biotechnology, clinical trial is a prospective study in human participants evaluating a medical intervention or health question tied to clinical development and regulated biomedical research. Mechanistically, the entity involves prospective human research study together with interventional study design, with investigational treatment evaluation helping distinguish one implementation from another. Clinical trial is the broad study concept; randomized controlled trials, adaptive designs, decentralized trials and individual trial phases are specific designs or stages within that broader category.
Phase III trial data volumes double every seven years as complexity becomes the new normal
Phase III clinical trials now generate 5.9 million data points per protocol on average, with data volumes rising 11 percent annually since 2020 and operational models straining to keep pace.
Australian government funds international CAR-T clinical trials for children
A new five million dollar grant from the Australian Government will bring international CAR-T clinical trials for childhood cancer to Australia, reducing the need for families to seek treatment overseas.
AI patient profiling challenges the meaning of failed clinical trials
A failed Phase 3 trial does not always mean a drug is ineffective. Luca Pani of NetraMark argues that AI-driven patient selection could transform how clinical evidence is generated and interpreted.
Bristol Myers Squibb's arlo-cel meets phase II goal in relapsed multiple myeloma
Bristol Myers Squibb reports that its phase II QUINTESSENTIAL trial of arlocabtagene autoleucel met the main goal in adults with relapsed and refractory multiple myeloma.
Andrew Dauber honored for advances in pediatric endocrinology research
Andrew Dauber, chief of Endocrinology at Children’s National, received the ESPE International Research Award in Marseille for his work on genetic growth disorders and precision medicine.
Holtec Nuclear delays IPO as Nscale eyes multibillion dollar debut
Holtec Nuclear abruptly postponed its $825 million IPO while Nscale filed for a potential $2 billion offering and Electra Therapeutics suffered a rare biotech IPO drop.
North Carolina biotech bets on proof before scale in a fragmented funding surge
North Carolina’s life sciences sector is taking a measured approach to growth, favoring smaller, risk-managed deals and targeted expansions, while a few major players make billion-dollar commitments.
Single CAR-T injection prompts immune reset in multiple sclerosis trial
A single in vivo CAR-T injection shows early promise for multiple sclerosis, while new research connects ADHD to digestive issues and looks at how wholegrain diets affect heart risk factors.
Certara tackles clinical data headaches with early standards checks
Certara is betting that catching data standard problems at the source can save clinical trial sponsors months of costly remediation and regulatory headaches.