Eye on FDA

JANUARY 5, 2022

FDA has scheduled the first advisory committee meetings of 2022. But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021. Fewer Meetings. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice?

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Express Pharma

MARCH 21, 2023

In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.

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PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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RX Note

JANUARY 21, 2023

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

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Compounding Community Pharmacies Clinical Pharmacology Dosage 40

European Pharmaceutical Review

MAY 2, 2023

billion in 2022, the average projected return on investment (ROI) in R&D was just 1.2 He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow. Available from: [link] Worldwide cancer statistics [Internet].

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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. 2022; 7(93) Maecker et al. Exploration of the antibody–drug conjugate clinical landscape. References Fu et al. Signal Transduct Target Ther. 2023;15(1) Shastry et al.

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Chemotherapy Clinical Pharmacology 59

PharmaShots

MARCH 9, 2023

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Hatfield Economic Fellow at Cornell University in 2022. She was also selected as the 39th Robert S.

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Putting Patients First Blog

SEPTEMBER 26, 2024

NHC comments on FDA diversity in clinical trials guidance. Clinical Pharmacology & Therapeutics , 97(3) , 263–273. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. Eligibility criteria in NIH-funded clinical trials: Can adults with intellectual disability get in?

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