UMN Pharma Inc., of Akita, Japan, and Catalent Pharma Solutions, of Somerset, N.J., signed a deal in which Catalent will provide UMN a broad range of biosimilar cells lines using its GPEx technology

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients

Akela Pharma Inc., of Vancouver, British Columbia, said its voluntary delisting from the Toronto Stock Exchange occurred at the close of trading Dec. 7

Isotechnika Pharma Inc., of Edmonton, Alberta, reported positive anti-hepatitis C virus (HCV) results from the second round of in vitro testing of its cyclophilin antagonist molecules (NICAMs

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients

Akela Pharma Inc., of Vancouver, British Columbia, said it applied for voluntary delisting from the Toronto Stock Exchange, citing an inability to maintain the continuous listing requirements

Isotechnika Pharma Inc., of Edmonton, Alberta, said a partial award has been issued in the company's ICC arbitration regarding its right to terminate the development, distribution and license agreement with Iljin Life Sciences Co

AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said the FDA accepted the new drug application (NDA) for tivozanib, tentatively branded Tivopath, in the proposed indication of advanced renal cell carcinoma (RCC

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test

Early this year, Theravance's partner for Vibativ, Astellas Pharma Inc., of Tokyo, handed back full rights to the program. (See BioWorld Today, Dec. 1, 2009

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test

Neptune's subsidiary Acasti Pharma Inc

Isotechnika Pharma Inc., of Edmonton, Alberta, reported that screening of its cyclophilin antagonist molecules turned up several compounds that were highly active against important viruses, including hepatitis C virus, human papillomavirus, human cytomegalovirus and varicella zoster virus

AlphaCore Pharma Inc., of Ann Arbor, Mich., said it received orphan designation from the European Medicines Agency for ACP-501 for familial LCAT deficiency (FLD), a rare, inherited condition that causes lipid accumulation in the eyes, red blood cells and kidneys

Acceleron Pharma Inc., of Cambridge, Mass., reported preclinical data demonstrating positive effects of ACE-536, a modified Type II activin receptor fusion protein, to treat both the severe anemia and serious organ damage due to iron overload in a model of beta-thalassemia

Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome

QR Pharma Inc., of Berwyn, Pa., said data presented at the Annual Biotech Symposium in Philadelphia showed that posiphen recovered memory, learning and brain function in Alzheimer transgenic mice

Astellas Pharma Inc., of Tokyo, said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adults with overactive bladder syndrome

Kite Pharma Inc., of Los Angeles, entered a Cooperative Research and Development Agreement with the National Cancer Institute for the development and commercialization of novel engineered peripheral blood autologous T-cell therapeutics for the treatment of multiple cancer indications