The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million…
Human radiolabeled mass balance studies are the most direct way of gathering quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft…
A pooled data analysis of phase 2b and 3 data is strengthening claims that a single dose of nirsevimab can protect infants from respiratory syncytial virus (RSV) infections. Source: Drug…
The FDA hit Carlsbad, Calif.-based SAFC Carlsbad — a MilliporeSigma property — with a seven-observation Form 483 following a December 2021 inspection, citing inadequate handling of biohazardous materials and other…
On Monday, a two-week trial got under way to determine the contributions that pharmacy chains CVS Health Corp, Walgreens Boots Alliance and Walmart made to the opioid crisis in two…
Pfizer has acquired Biohaven Pharmaceutical and its migraine drug Nurtec ODT (rimegepant sulfate), which is approved for both the prevention and treatment of episodic migraine in adults. Source: Drug Industry…
The FDA is soon to explore new “intermediate” approval pathways that might be more appropriate for certain cellular and gene therapy products than the regulatory pathways they face now. Source:…
A planned International Council for Harmonization (ICH) guideline on model-informed drug development (MIDD) will help optimize clinical trial designs, according to ICH, which estimates development of the guideline will be…
The European Medicines Agency’s (EMA) safety committee has warned that Jazz Pharmaceuticals’ Defitelio (defibrotide) should not be used for preventing veno-occlusive disease (VOD) — a rare condition in which veins…
An FDA-funded study suggests that different generic levothyroxine products appear equally effective, potentially laying to rest clinical concerns about how switching among them might impact blood levels of thyroid stimulating…