Drug Development
Flagging a risk of hypoglycemia, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Friday did not recommend the approval of Novo Nordisk’s once-weekly insulin icodec for type 1 diabetes.
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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The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.
For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
While almost half of multiple myeloma patients on linvoseltamab achieved a complete response or better, all experienced adverse events and 14 patients died due to treatment-emergent AEs.
In this episode, hear from senior leaders at Microsoft and IQVIA to get their take on how generative AI is impacting productivity, employee engagement and how to mitigate risks.
The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases.
Transfer RNA’s unique biology could enable a mutation-specific, gene-agnostic—and more cost effective—approach to developing treatments for thousands of rare and ultra-rare diseases.
The study found only 19% of nearly 2,000 patients were still taking their prescribed anti-obesity medication at 12 months, compared to 40% that continued with Novo Nordisk’s Wegovy.
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more.