December 5, 2020 — Late on Friday, Novo Nordisk announced FDA approval for Saxenda (liraglutide 3mg) to treat obesity in teens. This marks the second such drug approved in for youth in little more than a week. Setmelanotide received approval last week for children as young as six. Make no mistake about it, we are making progress in expanding […]
November 28, 2020 — This is the ultimate Friday news dump. FDA approved a highly innovative, highly targeted treatment for obesity – setmelanotide – Wednesday night. Just before a four-day holiday. The company announced in on Friday – timing one would typically choose for news they want to hide. But this is really good news for the treatment of […]
October 25, 2020 — After two decades of really bad publicity, sugar is reinventing itself. Just last week, FDA finalized its rules for allulose, a rare but natural form of sugar. It looks and tastes a lot like regular sugar, though it’s about one third less sweet. But the really sweet deal is that the final rule from FDA […]
September 26, 2020 — We are in a season where identity is right out front. Everywhere you turn, people are declaring what they stand for and who they’ll vote for. We see banners, little garden flags, even a pickup-sized flag tacked on to a bike by a scrappy old man pedaling furiously down the street. We humans seem driven […]
September 10, 2020 — Back in February we complained about “a near complete failure of transparency in drug safety decision making” by FDA. Our complaint had to do with taking lorcaserin (Belviq) off the market. Today, FDA took a step toward a bit more transparency. In the New England Journal of Medicine, senior FDA officials explained their thinking about […]
June 30, 2020 — It’s tough getting good information these days. Good, factual information. Everybody wants to spin it. That’s undeniable in public policy. But it also seems to be true in drug development. Yesterday, the FDA definitively rejected an application from Intercept Pharmaceuticals for a new drug to treat NASH – nonalcoholic steatohepatitis. The company was shocked. Its […]
May 18, 2020 — We call it stealth progress. Rhythm Pharmaceuticals last week gained approval from FDA for a priority review of setmelanotide for rare genetic forms of obesity in children. The indications are for obesity treatment in POMC and LEPR deficiency. Furthermore, the FDA has indicated it doesn’t plan to hold a public hearing on this drug This […]
March 18, 2020 — A public health emergency can have an unfortunate side effect. With the coronavirus pandemic, pseudoscience, quackery, and fraud are emerging, too. Diets and supplements to “boost” your immune system are a common form of this fraud. Honestly, sometimes this sort of misinformation flies under the radar of normally discerning people. But we praise Dietitians of […]
February 14, 2020 — FDA yesterday requested that Eisai withdraw lorcaserin (Belviq®) from the market due to a small increase in cancer observed in a large cardiovascular safety study. Eisai disagreed with the request but complied with the request nonetheless. We have no data to help us understand what is going on. Is FDA over-reacting to a spurious observation? […]
August 9, 2019 — New data from Rhythm Pharmaceuticals this week tells us that a new, highly targeted obesity therapy may become available soon. The data come from two phase 3 studies of setmelanotide in rare cases genetic obesity. With these positive results in hand, Rhythm expects to file for FDA approval in late 2019 or early 2020. Thus, […]
