Drugs

Pfizer Dumps Lotiglipron on Liver Injury Concerns

Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor agonist (GLP-1-RA) anti-diabetes candidate lotiglipron due to liver injury concerns and will instead “continue to progress one oral late-stage” GLP-1-RA candidate, danuglipron, toward further clinical development for treating adults with obesity and Type 2 diabetes mellitus. Pfizer expects to finalize plans for the danuglipron late-stage program by the end of the year, and says it is also developing a once-daily modified-release version. “If successful in clinical trials and approved, danuglipron could be in a prime position to differentiate based on profile, including full receptor agonism, which we believe has the potential to translate to robust efficacy,” it adds.

Pfizer’s decision to abandon the lotiglipron clinical development program was based on pharmacokinetic data from Phase 1 drug-drug-interaction studies (C3991040 – NCT05671653 and C3991047 – NCT05788328) and elevated transaminases recorded in laboratory measurements during these studies as well as the ongoing Phase 2 study C3991004 (NCT05579977). “None of these participants reported liver-related symptoms or side effects, there was no evidence of liver failure, and none needed treatment,” it says.

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