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© 2023 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Check out the latest features and columns!
Jim Kremidas, former executive director, Association of Clinical Research Professionals, shares his experiences as a patient in clinical trials.
Senior leaders gather to share insights on the increased investment in real-world data to boost the quality and efficiency of drug development.
November 30, 2023
Included in the FDA warning were levetiracetam, under the brand names Keppra and Keppra XR; Elepsia XR; Spritam; and clobazam, under the brand names Onfi and Sympazan.
DREAMM-7 was a Phase 3, multicenter, open-label, randomized trial analyzing the efficacy and safety of Blenrep plus bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma previously administered at least one prior line of treatment.
KRP203 (mocravimod) is intended to improve outcomes after hematopoietic stem cell transplantation for the treatment of hematologic malignancies.
Arcutis Biotherapeutics’ supplemental new drug application was supported by significant findings from a trio of Phase 3 trials, a Phase 2 dose ranging trial, and a pair of Phase 1 pharmacokinetic studies for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older.
November 29, 2023
Data from the EMERGENT clinical trial program show Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) produced statistically significant and clinically meaningful improvements in the symptoms of schizophrenia.
The clearance includes the Vivos Therapeutics, Inc's DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance for adults with severe obstructive sleep apnea.
Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all.
November 28, 2023
Results from decade-long analysis suggest great improvement is needed in the quality of control groups.
The Elecsys HBeAg quant can detect the presence and quantity of the hepatitis B e antigen (HBeAg) in human serum and plasma.
Results from the Phase 3 DeFi trial (NCT03785964) showed that nirogacestat (Ogsiveo) reduced the risk of disease progression or mortality by 71% compared with placebo.