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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
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 complete in three to four years. Read More
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 in the liver become clogged and stop the liver from functioning properly. Read More
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 hormone (TSH). Read More
The FDA’s Center for Biologics and Evaluation Research (CBER) put out its planned list of guidance documents it expects to release in 2022, including several that focus on gene therapies and regenerative medicines. Read More