Drugs

Large Molecule Drug Trials Take Longer: Analysis

KMR Group says its annual Clinical Trial Cycle Time report shows that the duration of clinical trials associated with large molecule drugs is significantly longer than it is for trials associated with small molecule drugs. The consultants say that even after accounting for disease complexity and study size, large molecule trials are consistently longer at a statistically significant level. “This finding holds across phases,” the analysis says, “where large molecule trials tend to take longer in Phase 1 healthy volunteer studies as well as Phase 2 and 3 studies.”

The report found that not just one particular process drives the results. Rather, most processes (study startup, enrollment, data capture) are longer for large molecule trials, in addition to lower recruitment rates.

“Given the complexity and challenges associated with large molecules, it is not surprising there is variance,” says KMR Group president Linda Martin. “However, understanding where the differences reside operationally, as well as the extent of the gaps and what influences them, can be critical to improving operational performance.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome