The FDA announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
Continue readingIndustry News: Topline Results from Phase 3 Trial of Amyloid-Clearing Drug Donanemab
Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingIndustry News: The FDA Granted an Investigational Device Exemption Approval for Sirolimus Coated Balloon For the Treatment of Small Vessels In Coronary Arteries
Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingIndustry News: U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine
Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingIndustry News: Pharma Industry Consortium Completes Brain Wave Study of Ketamine Effects on Healthy Subjects
Successful completion of a pharma industry-sponsored study to measure the electrophysiologic effects of ketamine on healthy brain function.
Continue readingIndustry News: Medical Reports Positive One-year Results for PADN-CFDA Trial in Pulmonary Arterial Hypertension (PAH) Treatment English
The data from the PADN-CFDA pivotal study provides strong evidence for the treatment of pulmonary arterial hypertension.
Continue readingIndustry News: Center for Breakthrough Medicines Launches Precision Plasmids™ Manufacturing to Accelerate Advanced Therapies into the Clinic
Superior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids.
Continue readingIndustry News: FDA Approves New HIV Drug for Adults with Limited Treatment Options
The FDA approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.
Continue readingIndustry News: How New Knowledge about Cancer Is Changing Clinical Trials
Over the last two decades, biomedical researchers have begun to unravel cancer’s immense complexity, drilling down to the molecular level to better understand the genetic and biological changes that drive how cancers develop, grow, and spread.
Continue readingIndustry News: Mediterranean diet improves immunotherapy response rates and progression-free survival in advanced melanoma
Eating a Mediterranean diet, rich in fiber, mono-unsaturated fatty acids and polyphenols, has been associated with improved immunotherapy response rates and progression-free survival in advanced melanoma patients.
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