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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quantitative data on a drug’s absorption, distribution, metabolism and excretion (ADME) in the human body, according to draft guidance the FDA issued last week. Read More
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. Read More
The pilot program will analyze data from pharmacy suppliers and consider such supply chain issues as available production capacity, flexibility and geopolitical risks. Read More
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 quality lapses. Read More
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 hard-hit Ohio counties. Read More
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. Read More
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. Read More