Some interesting things happening with pharma and biotech in regulatory intelligence, take a look:

  • Industry asks FDA to halt new off-label rule. Industry groups PhRMA, BIO, and the Medical Information Working Group have asked the Agency to stop a new rule on off-label promotion that was recently published in the Federal Register. (FiercePharma)
  • The FDA has lifted a clinical hold imposed last December on Seattle Genetics. After the deaths of four people involved in the studies, the company is now free to continue several trials testing their experimental cancer drug, vadastuximab talirine, for the treatment of acute myeloid leukemia (AML). (Reuters)
  • Lilly’s psoriasis study meets primary endpoint. Eli Lilly has published impressive results in a study comparing its psoriasis treatment, Taltz, to Johnson & Johnson’s Stelara. (Pharmafile)
  • Lilly and Chi-Med partner for success in colorectal cancer. Eli Lilly and China MediTech (Chi-Med) have announced positive top-line data in their phase 3 study of fruquintinib in locally advanced or metastatic colorectal cancer. The study, which was conducted in China, involved more than 400 patients. (FierceBiotech)
  • Karyopharm’s selinexor fails phase 2 study. Karyopharm reported that a phase 2 trial of selinexor in acute myeloid leukemia (AML) failed to show improved overall survival in a study of 176 patients. (FierceBiotech)


Tags: Aegis, aegis creative, biotech, clinical trials, drug development, FDA, life science, oncology, Reg Intel, Regulatory Intelligence

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