Drug Development

FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.
Preliminary data from a late-stage trial of Alnylam’s RNAi therapy for ATTR amyloidosis with cardiomyopathy appear strong but details expected later this summer are critical.

Eli Lilly’s Mounjaro outperformed Novo Nordisk’s Ozempic at inducing weight loss in obese or overweight adults, according to an observational study published Monday in JAMA Internal Medicine.
Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.
FDA
The groundwork being done in 2024 is building the foundation for global collaboration in the future.
GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, according to an analysis of electronic health records.
With the antibody drug conjugate market projected to hit $28 billion by 2028, some companies are looking to harness the drugs for immunotherapy.
The U.K.-based biotech is the latest to cash in on the hot antibody-drug conjugate space, closing a $115.5 million Series A round co-led by Novo Holdings and participation from Eli Lilly.

Patient assistance programs may actually be a two-way street, providing patients with drugs and companies with data.
Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.