JD Supra

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
Applied Clinical Trials Online

From Protocol to Payment: A Unified Path to Stronger, End-to-End Outcomes

See IQVIA’s new AI‑driven capabilities in the Clinical Trial Financial Suite (CTFS) in action—featuring live demos of CTFS Site Payments and Protocol Ingestion for CTFS GrantPlan. Learn how these ...
FierceBiotech

Risklick debuts new AI software that writes clinical trial protocols

A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...
FierceBiotech

Why Protocol-Ready Doesn’t Mean Trial-Ready in Ovarian Cancer Clinical Trials

Roughly 70 to 80% of ovarian cancer cases are diagnosed at an advanced stage, 1 where treatment options are limited and eligibility criteria for clinical trial participation become more difficult to ...

Nuvation Bio Inc. (NUVB) Amends Protocol on Safusidenib Trials in Astrocytoma

Nuvation Bio Inc. (NYSE:NUVB) is one of the best cancer stocks to invest in now. On February 9, Nuvation Bio Inc. (NYSE:NUVB) ...
STAT

Adaptive trial designs will increase clinical trial speed, safety, and effectiveness

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...
Nasdaq

Dyne Therapeutics Submits Revised ACHIEVE Trial Protocol Elevating vHOT as Primary Endpoint for U.S. Accelerated Approval of DYNE-101 in Myotonic Dystrophy Type 1

Dyne Therapeutics has announced a revised protocol for its ACHIEVE trial, elevating video hand opening time (vHOT) to the primary endpoint for U.S. Accelerated Approval of DYNE-101, a treatment for ...
Seeking Alpha

Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension (PAH) to the U.S. FDA

GOTHENBURG, Sweden, Nov. 10, 2025 /PRNewswire/ -- Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare ...
FiercePharma

Missed trial protocols, fabricated emails and failed endpoint mar BioXcel's Alzheimer's agitation readout

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXcel unveiled its phase 3 data ...
Business Insider

Aardvark Therapeutics Announces FDA Submission and IRB Approval of Amended Trial Protocol for Lead Candidate ARD-101, Expanding Eligibility in Phase 3 Study of Prader-Willi ...

SAN DIEGO, Feb. 10, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics ...
Managingip.com

Clinical trial protocols disclosed without results: a threat to patent novelty?

In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...