Protocols

TherapeuticsMD flags “deficiencies” in NDA; CRUK, NCI collaborate on RAS inhibitor research

→ Boca Raton, FL-based TherapeuticsMD $TXMD is flagging some serious problems for their new drug application at the FDA. In a statement today the company said regulators had identified “deficiencies” in their application, though it’s not exactly sure what those deficiencies are. They’re seeking a marketing approval for TX-004HR, “an investigational bio-identical 17β-estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.” The biotech says it plans to find out what the deficiencies are and resolve them ASAP.

→ Cancer Research UK and the Cancer Research Technology Research Fund are chipping in £2.5 million to fund a collaboration with the National Cancer Institute to test experimental RAS inhibitors, one of the toughest targets in cancer research. RAS drives some particularly lethal cancers, like pancreatic and lung cancer.

Emmaus Life Sciences says the Oncologic Drug Advisory Committee will review its NDA for the oral L-glutamine product Endari, for the treatment of sickle cell disease.

→ San Carlos, CA-based Lion Biotechnologies $LBIO is teaming with the MD Anderson Cancer Center on a multi-year pact involving clinical trials to evaluate TIL therapy in ovarian cancer, various sarcomas, and pancreatic cancer. In addition, preclinical research will explore the expansion of TIL in other rare tumor types.


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