NRT competition
This article was originally published in The Tan Sheet
Executive Summary
Pfizer's NDA for its smoking cessation drug varenicline tartrate has been granted a six-month priority review by FDA, the firm announces Dec. 21. The product would be marketed as an Rx drug under the brand name Champix if approved. According to Pfizer, the brain's nicontinic receptor triggers a sense of satisfaction when nicotine is inhaled, but the effects recede quickly, creating a cycle of craving and withdrawal. Varenicline is designed to activate the nicotinic receptor to "reduce both the severity of the smoker's craving and the withdrawal symptoms," the firm maintains. Pfizer notes that priority reviews are assigned to drugs "that may provide a significant therapeutic advance over existing therapies." The drug's NDA was submitted in November...
You may also be interested in...
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.
ViiV Anticipates 10%-15% Switchover To Long-Term HIV Option Cabenuva
The company is optimistic about a significant portion of eligible patients opting for its newly approved long-acting HIV therapy over daily, oral antiviral therapy.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: