Merck has announced that they are discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity.
Merck has announced that they are discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity. According to the results of a phase 3 study presented at the 57th Annual Scientific Session of the American College of Cardiology in March 2008, patients treated with taranabant in combination with diet and exercise experienced statistically significant weight loss compared with patients treated with placebo. Phase 3 data demonstrated, however, that more adverse events were observed in patients treated with higher doses of the agent, an outcome that led to Merck’s decision to halt development.
Rimonabant, another CB-1 receptor antagonist, was withdrawn from regulatory consideration by Sanofi-Aventis in 2007. An FDA advisory committee had recommended against approval of the agent because of an increased risk of psychiatric and neurologic adverse effects in patients treated with rimonabant.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More