What is “Enforcement Discretion” (FDA context)?
Enforcement discretion means that a regulatory agency like the FDA (U.S. Food and Drug Administration) chooses not to enforce certain rules or regulations under specific circumstances, even if technically a violation has occurred. This is often done:• To avoid disrupting access to critical healthcare (e.g., during emergencies like COVID-19).• When the agency believes that the […]
Retatrutide: A Triple Agonist for Diabetes and Obesity
Abdul-Rahman T, Roy P, Ahmed FK, Mueller-Gomez JL, Sarkar S, Garg N, Femi-Lawal VO, Wireko AA, Thaalibi HI, Hashmi MU, Dzebu AS, Banimusa SB, Sood A. The power of three: Retatrutide’s role in modern obesity and diabetes therapy. Eur J Pharmacol. 2024 Dec 15;985:177095. doi: 10.1016/j.ejphar.2024.177095. Epub 2024 Nov 6. PMID: 39515565. Comprehensive narrative review focusing on retatrutide, […]
The “summer body” is over. Something worse is taking its place.
Women in bathing suits lined up on the beach in 1949. | FPG/Getty Images For decades, women have heard about the mythical “summer body” — toned arms, ripped abs, no cellulite. Some people also call this narrow goal “bathing suit ready,” or talk about having a “beach body.” In the months leading up to the […]
Q&A: Long-term success of GLP-1 therapies hinges on more than just a prescription
GLP-1 (glucagon-like peptide-1) therapies can be powerful tools in managing obesity, with patients taking these medications seeing weight reductions of 5%–18% in clinical trials, along with increased metabolism and benefits to their overall heart health. However, GLP-1s can come with challenges, including gastrointestinal side effects, risk of micronutrient deficiencies, muscle and bone loss, poor long-term […]
Weight loss drugs could make oral contraception less effective, MHRA warns
Women who take weight loss drugs should use barrier contraception if they are seeking to avoid pregnancy, the medicines regulator has advised.The Medicines and Healthcare Products Regulatory Agency has issued guidance warning that the drugs could reduce the effectiveness of oral contraceptives.1 The agency said it had received reports of 40 pregnancy related adverse events […]
GLP-1 study: Gencor running second trial after positive initial findings
STAT+: Pharmalittle: We’re reading about Novo Nordisk’s cautious culture, FDA approvals, and more
Good morning, everyone, and how are you today? We are doing just fine, thank you, despite rising temperatures and hazy skies looming over the Pharmalot campus. After all, the birds are still chirping and a cool breeze is wafting by. Moreover, our official mascots are snoozing somewhere on the premises. We can hear the heavy […]
A cautious culture cost Novo its obesity lead
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. It’s hard to be the first company in a new disease area or drug class, and perhaps even harder to maintain a lead. We dig into that today.pharma Read the rest…
An accidental email, Covid confusion, & how Novo fell behind
Good morning. The best part about having a library card is that even when you have three overdue books, you can still request new ones with no penalty. (I’ll return them soon, I swear!) Today, I requested “Forgetting Elena,” the 1973 debut novel of Edmund White, who died earlier this week. UnitedHealth accidentally sent STAT a […]
Digital health startup Virta stakes fees on curbing GLP-1 prescriptions
In a move to put its money where its mouth is, digital health startup Virta Health said it’s now guaranteeing employers they won’t see increased GLP-1 weight loss prescriptions, or they’ll get their money back …