When glucagon-like peptide-1 (GLP-1) receptor agonists entered the market for obesity and overweight indications in recent years, the uptake and enthusiasm drove investor excitement for companies advancing any of the new mechanisms in the space.
In a threshold event in the U.S., Medicare is planning to break through its obesity coverage barrier with a voluntary test of a model designed to enable Medicare Part D plans and state Medicaid programs to cover GLP-1 drugs prescribed for weight management.
Needle-phobic obesity patients got their first workaround with the U.S. FDA clearance of Novo Nordisk A/S’ once-daily GLP-1 Wegovy (semaglutide) pill, the first of its kind.
A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.
A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with Alzheimer’s disease, investors and researchers got the first look at the actual data from the studies, which were presented at the Clinical Trials on Alzheimer’s Disease 2025 meeting.
The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.
In a phase II study, Novo Nordisk A/S’s amycretin reduced the weight of type 2 diabetes patients by 14.5% in 36 weeks, a statistically significant loss. The results also produced reduced hemoglobin A1C levels, an average of blood glucose that is used to monitor blood sugar control, below 7% in up to 89.1% of the participants.
Novo Nordisk A/S’ wild card bet that its GLP-1 receptor agonist semaglutide could be used to treat Alzheimer’s disease has not paid off, with the company reporting two phase III trials have shown no effect on slowing disease progression.
In a verbal sparring over who can deliver the lowest drug prices in the U.S., several Senate Democrats are urging President Donald Trump to immediately release the list of second-round Medicare-negotiated drug prices, instead of doing what they characterize as “ambiguous” and “opaque” pricing deals with individual biopharma companies.
