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Daiichi Sankyo, Inc., the U.S. subsidiary of Daiichi Sankyo Company, will establish a new U.S. headquarters in Basking Ridge, NJ to continue collaboration between the business segments, enabling innovation in its existing and emerging therapeutic areas such as cardiology, oncology, pain and other areas where there are unmet medical needs. Daiichi Sankyo, Inc., is comprised of U.S.-based development functions, currently in Edison, NJ, and all U.S. commercial departments, currently in Parsippany, NJ.

 

Repros Therapeutics says new Phase 2 clinical data show that vaginal administration of Proellex at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, a key symptom of uterine fibroids. “When a sufficient concentration of Proellex is achieved in circulation, amenorrhea (cessation of menses) is achieved,” the company explains. Repros believes Proellex represents a significant advantage over GnRH agonists and antagonists in treating uterine fibroids. It will soon request an end of Phase 2 meeting with FDA to discuss plans for Phase 3 studies.

 

Lonza reportedly has offered to purchase drug delivery technology company Catalent. The proposed merger would expand Lonza's life sciences capabilities, permitting the company to produce a larger variety a molecules used in active pharmaceutical ingredients and drug delivery.

 

Celator Pharmaceuticals says that an investigator-initiated Phase 2 clinical study at a university of Vyxeos was reported as suspended on www.clinicaltrials.gov, but it was due to resource considerations at the university, unrelated to Vyxeos (CPX-351). Vyxeous was being studied for treating acute myeloid leukemia or higher risk myelodysplastic syndrome patients, who relapsed, or were refractory to, prior therapy with hypomethylating agents. Celator understands that the study has since been re-opened.

 

Northwestern Medicine researchers reported on results of a Phase 3 breakthrough clinical trial published in the 4/18 issue of Diabetes Care, that found transplanted human islets prevent hypoglycemic events and provide excellent glycemic control for patients with Type 1 diabetes with severe hypoglycemia. According to the university, investigators at eight sites in North America, including Northwestern Memorial, enrolled 48 adults who had Type 1 diabetes for more than five years. Researchers found that nearly 88 % of the 48 subjects who received islet transplants were free of severe hypoglycemic events, had restored hypoglycemia awareness and had excellent glycemic control at one year.

 

Morphotek, Inc., a subsidiary of Eisai says results from the Phase 3 MORAb-003-004 safety and efficacy study of weekly farletuzumab (MORAb-003) in combination with a platinum standard chemotherapy regimen (carboplatin plus taxane) in platinum-sensitive ovarian cancer patients in first relapse were recently published in the Journal of Clinical Oncology. The company says neither farletuzumab dose met the study’s primary progression-free survival  endpoint when compared to placebo and there was no difference in overall survival.

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