Hims & Hers Health Inc. (HIMS) shares surged on Monday after the FDA announced a reconsideration of its decision to prohibit drug compounders from selling their own versions of blockbuster weight loss medications. This decision stems from a lawsuit filed by the Outsourcing Facilities Association, challenging the FDA’s removal of tirzepatide, the active ingredient in Eli Lilly’s Mounjaro and Zepbound, from its shortage list.
The FDA is reconsidering its decision to ban compounding pharmacies from supplying cheaper versions of Eli Lilly’s blockbuster weight loss and diabetes drugs, Mounjaro and Zepbound. This comes after a lawsuit filed by compounding groups challenging the FDA’s restriction. Eli Lilly has also issued cease-and-desist letters to companies offering similar products, citing potential safety concerns.
The FDA has declared the shortage of tirzepatide, a popular weight-loss drug, resolved. However, semaglutide, another weight-loss medication, remains in short supply. This development raises questions about the long-term viability of compounded GLP-1 treatments, with Hims & Hers Health, a provider of compounded GLP-1s, seeing continued strong demand, but facing investor concerns.
Philips has issued a critical recall for its Trilogy Evo ventilators due to a software bug that could cause a sudden loss of ventilation, potentially leading to serious injury or death. The FDA has classified this recall as the most serious type, urging users to immediately install a software update to address the issue.
The FDA has granted Priority Review to AstraZeneca’s Calquence (acalabrutinib) for the treatment of previously untreated mantle cell lymphoma (MCL). This decision follows promising results from the ECHO Phase III trial, which demonstrated that Calquence, in combination with bendamustine and rituximab, significantly reduced the risk of disease progression or death compared to standard-of-care chemotherapy.
As the cannabis industry evolves, the focus has shifted away from medical marijuana and towards adult-use legalization. Debra Borchardt, executive editor of Green Market Report, highlights the lack of FDA-approved clinical trials and the potential impact of hemp bans on medical cannabis. Borchardt expresses concern about the future of medical marijuana and the potential for patient access to be limited as adult-use cannabis continues to dominate the conversation.
The FDA has approved Bristol Myers Squibb’s Cobenfy, an oral medication for schizophrenia in adults. Analysts predict significant potential for the drug, particularly in treating Alzheimer’s related psychosis, with projected peak sales exceeding $6 billion. However, despite its first-mover advantage, Cobenfy faces competition from AbbVie’s emraclidine, while potential side effects are also noted.
The FDA has approved AstraZeneca’s Tagrisso for treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed after radiation therapy. The drug, which generated $1.6 billion in sales in the second quarter of 2024, showed a significant reduction in disease progression or death compared to placebo in a Phase 3 trial.
The FDA’s Oncologic Drugs Advisory Committee will discuss the use of immune checkpoint inhibitors in patients with stomach and esophageal cancers, potentially limiting their use for those with low PD-L1 expression due to lack of benefits and possible risks.
The FDA has approved Sanofi’s Sarclisa (siltuximab) in combination with VRd as a first-line treatment for adult patients with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant. This approval makes Sarclisa the first anti-CD38 therapy in combination with VRd to significantly reduce disease progression or death in this patient population.
