GLP-1
Other notable greenlights this year include Bristol Myers Squibb’s Cobenfy, the first novel therapeutic for schizophrenia in 35 years, and Madrigal Pharmaceuticals’ Rezdiffra, the first-ever treatment for MASH.
The mega-blockbuster weight loss GLP-1 drug is now also approved to treat obstructive sleep apnea in adults with obesity, in combination with diet and exercise.
Layoffs slowed in the second half of the year but many companies still cut hundreds or even thousands of employees since January.
Already established as cornerstone therapies in diabetes and obesity, GLP-1 receptor agonists also show potential in several other indications, including cancer, addiction and neurodegenerative diseases.
Novo Nordisk executives set a high bar for itself when it projected CagriSema could achieve 25% weight loss. When the GLP-1 combo didn’t hit that mark, investors reeled.
Investors appeared disappointed by CagriSema’s Phase III readout, which showed weight loss that fell short of Novo Nordisk’s prior projections for the therapy. Meanwhile, Eli Lilly’s stock rose on the news.
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
According to the World Health Organization, GLP-1 receptor agonists are currently being used in a highly medicalized manner. Healthcare systems need to enact more holistic solutions, focusing on health promotion, disease prevention and policy interventions.
Following an appeal by the Danish Medicines Agency, the European Union’s drug regulator will review two new studies that have strengthened the link between Novo Nordisk’s blockbuster GLP-1 and a rare eye disease.
Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.
PRESS RELEASES