In its Complete Response Letter, the regulator made “requests” related to the drug candidate’s manufacturing process, Novo said in its announcement. The FDA also raised concerns related to the use of insulin icodec in type 1 diabetes (T1D).
The Federal Trade Commission plans to file lawsuits against the three largest pharmacy benefit managers over allegedly steering patients away from less expensive drugs, according to The Wall Street Journal.
The company made the announcement based on results from the ongoing pharmacokinetic study (NCT06153758), selecting its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
The medical equipment maker posted second-quarter adjusted core profit in line with expectations on Thursday, driven by the deal pipeline for its plastics and devices business, which supplies weight-loss drug makers with autoinjector pens.
The drugmaker slashed its 2024 profit forecast while signaling a slowdown in sales of its top-selling opioid addiction treatment, and said it would discontinue sales of its schizophrenia drug Perseris, prompting its shares to plunge 44% on Tuesday.
WPP announced AstraZeneca has appointed the network, led by VML Health, to the pharma giant’s roster for its U.S. and global oncology creative business. The WPP team will be based out of the United States and UK, and will also be comprised of Grey Health and Ogilvy Health.