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• Brekiya becomes the first and only dihydroergotamine autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

• Amneal’s autoinjector provides patients with the potential for sustained pain relief in a self-administered form. It contains the same medication used in hospitals, now in a ready-to-use device.

• It also does not require refrigeration, assembly, or priming of the device. The product will be available in the second half of 2025. (PharmaLive)

• The FDA expanded the approval of Welireg (belzutifan) to include certain types of pheochromocytoma or paraganglioma (PPGL) in adults and children.

• PPGLs comprise a group of rare neuroendocrine tumors that have an incidence of approximately 0.57 per 100,000 person-years. The tumors occur in 0.1% t0 0.6% of patients with hypertension and account for about 5% of adrenal incidentalomas.

• A hypoxia-inducible factor-2α inhibitor, Welireg previously received approval for advanced renal cell carcinoma and certain subtypes of von Hippel-Lindau disease. (MedPage Today)

• The FDA granted accelerated approval to Emrelis (telisotuzumab vedotin) in second-line non-small cell lung cancer for patients with overexpression of a protein called c-Met. No immediate pricing information was available.

• The decision gives AbbVie another avenue to make up for declining sales of Imbruvica, a longtime blood cancer blockbuster that’s held up the company’s oncology revenue since it acquired the biotech that developed the ADC, Pharmacyclics, in 2015 for $21 billion. (Endpoints)

• The executive order seeks to tie US drug prices to lower prices in other developed nations. While there are many unknowns about the measure, the industry was quick to hit back and share its concerns.

“Should the proposed Executive Order go into effect, Roche’s ability to fund the significant investments previously announced in the US will be in question,” a Roche spokesperson said via email.

“Overall, we are concerned that the Executive Order will undermine the US’s position as the world’s leading pharmaceutical and healthcare ecosystem, as well as dampen economic growth and lead to job losses in the US.”

• The investment push includes several new manufacturing plants and an expansion and upgrade of pharma and diagnostics R&D centers in several states.

• "Without broader reforms to healthcare delivery in the US, referencing international prices does little to nothing to impact patient out of pocket cost for medicines," the company stressed.

• Novo Nordisk is looking to stay on top of the obesity drug market as competitors race ahead, striking a deal with Septerna to co-develop small molecule oral obesity drugs. Novo is fronting $200 million off the bat and up to $2.2 billion in R&D and milestone payments.

• The two companies will create small molecule drugs for obesity, type II diabetes and other cardiometabolic diseases aimed at G-protein coupled receptors (GPCRs), including GLP-1, GIP and glucagon, according to a release announcing the licensing deal. (BioSpace)

• The asset, efimosfermin, has already passed mid-stage tests and is now a phase 3-ready therapy to help stop the progression of steatotic liver disease (SLD), a condition where fat builds up in the liver.

• If left untreated, this can lead to increasing levels of liver damage through scarring and cirrhosis.

• The therapy, which was once owned by Novartis, works as a once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic and is being assessed in metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, with GSK eyeing future work in alcohol-related liver disease (ALD), both of which are forms of SLD. (Fierce Biotech)

• The new Oikos Protein Shakes will be released this month on Amazon and other select retailers, including Kroger and CVS stores nationwide.

• The shakes have 30 grams of protein and 5 grams of prebiotic fiber and come in three flavors: vanilla, chocolate and salted caramel.

• Eating a high-protein diet is important to maintain muscle for people taking the injectable treatments and others looking to lose weight, research shows.

• Nearly 18 million Americans are expected to be taking versions of GLP-1 drugs by 2029, according to investment bank UBS. (Axios)