Express Pharma
JANUARY 19, 2025
1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. 2024 Jul 27;1842:149129. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318. DOI: 10.1016/j.brainres.2024.149129. 2024.149129.
FDA Law Blog: Biosimilars
JULY 17, 2024
Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,
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European Pharmaceutical Review
JULY 18, 2024
This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2024; 21 203–223 The post Uncovering the potential of ADCs to target tumours appeared first on European Pharmaceutical Review. Rise of Antibody-Drug Conjugates: The Present and Future.
Putting Patients First Blog
SEPTEMBER 26, 2024
NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials (PDF) September 26, 2024 The Honorable Robert M. Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies [Docket No. 8 Scott, P.,
Pharmaceutical Technology
FEBRUARY 17, 2023
In 2021, Amgen agreed to conduct a Phase II study (NCT04933695), which is supposed to complete in May 2024, according to Clinicaltrials.gov. If the new clinical study finds that a lower drug dose can achieve similar efficacy, the hope is that this could result in fewer side effects for patients.
European Pharmaceutical Review
MARCH 7, 2025
A paper published by the Drug Safety Research Unit (DSRU) in the British Journal for Clinical Pharmacology , has asserted the need for ongoing assessment of the safety and effectiveness of the Alzheimers drug lecanemab in the real-world clinical setting.
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. On the other hand, CBER provided no additional guidance as to when a clinical endpoint would be appropriate as an intermediate clinical endpoint to support accelerated approval.
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