Roche has run into another roadblock for its investigational dual-agent chemotherapy regimen targeting PD-L1-high locally advanced or metastatic nonsmall-cell lung cancer (NSCLC). Source: Drug Industry Daily
The FDA’s Center for Drug Evaluation and Research (CDER) is launching a new initiative to speed and increase the development of treatments for rare diseases. Source: Drug Industry Daily
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…