Drugs

Tanezumab Study Meets Efficacy Endpoints

Pfizer and Lilly say a Phase 3 study of the efficacy and safety of subcutaneous administration of their investigational humanized monoclonal antibody tanezumab in patients with osteoarthritis pain met all three co-primary efficacy endpoints. The companies say that in patients with moderate-to-severe osteoarthritis pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function, and patients’ global assessment of their osteoarthritis, compared to placebo.

Pfizer tanezumab development team leader Ken Verburg said the results are particularly meaningful given that patients had moderate-to-severe pain and were unable to achieve adequate pain relief with other treatment options, including opioids and NSAIDs.

Tanezumab is described as an investigational humanized monoclonal antibody that works by selectively targeting, binding to, and inhibiting nerve growth factor (NGF). By inhibiting NGF, the companies say, tanezumab may help to keep pain signals produced by muscles, skin, and organs from reaching the spinal cord and brain. It is said to have a novel mechanism that acts in a different manner than opioids and other analgesics, and in studies to date has not demonstrated a risk of addiction, misuse, or dependence.

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