Cubist Pharmaceuticals Inc., of Lexington, Mass., and Astellas Pharma Inc., of Tokyo, said they entered an agreement under which Cubist obtains the rights to ceftolozane in certain Asia-Pacific and Middle East territories from Astellas

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency

Medivation Inc., of San Francisco, said net sales of Xtandi (enzalutamide) capsules for the quarter, as reported by its partner Astellas Pharma Inc., of Tokyo, were $57.4 million

Potential merger and acquisition partners for Optimer include Astellas Pharma Inc...Optimer partnered with Astellas Pharma Europe Ltd

AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said the FDA's Oncologic Drugs Advisory Committee will review the new drug application for tivozanib for patients with advanced renal cell carcinoma during the morning session of its May 2 meeting

The current standard of care for atopic dermatitis includes corticosteroids and calcineurin inhibitors such as Prograf (tacrolimus, Astellas Pharma Inc

San Diego-based Ambit is partnered with Astellas Pharma Inc

Company (Location) Product Description Indication Status Date Allergan Inc. (Irvine, Calif.) Botox Onabotulinum-toxinA Overactive bladder FDA approved it 1/23/13 Astellas Pharma Inc. (Tokyo) Betmiga Mirabegron Overactive bladder Received European approval 1/14/13 Astellas Pharma Inc. (Tokyo) Tarceva Erlotinib Non-small-cell lung cancer FDA accepted for filing a supplemental NDA for first-line use in patients with locally advanced or metastatic disease whose tumors have epidermal growth factor

The trial, designated TIVO-1, was carried out in partnership with Astellas Pharma Inc., of Tokyo

EGFR inhibitor Tarceva (erlotinib, Astellas Pharma Inc.) is also used in lung cancer, while HER2-overexpressing breast cancers are the target of Herceptin (trastuzumab, Roche

ASG-5ME is an antibody-drug conjugate targeting the SLC44A4 antigen and is being co-development with Agensys Inc., an affiliate of Tokyo-based Astellas Pharma Inc

Piper Jaffray's Ian Somaiya noted that Tarceva (erlotinib, Astellas Pharma Inc.) was approved with only 0.33 months improvement in survival, and that safety could be a key differentiator in the marketplace

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Astellas Pharma Inc

Tivozanib – an oral, once-daily, VEGF receptor tyrosine kinase inhibitor, partnered by AVEO with Astellas Pharma Inc., of Tokyo – turned up pleasing results in the Phase III trial that compared progression-free survival rates with Nexavar (sorafenib, Onyx Pharmaceuticals Inc.) in kidney cancer, but overall survival (OS) rates caused some eyebrows to rise

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults

Company (Location) Product Description Indication Status Date Alfa Wassermann SpA (Bologna, Italy) and Norgine BV (Amsterdam, the Netherlands) Xifaxan 550-mg (rifaximin-alpha)/Refero/Targaxan/Tixteller Hepatic encephalopathy Received European marketing authorization 12/10/12 Astellas Pharma Inc. (Tokyo) Tacrolimus Extended-release capsules Organ rejection in adult kidney transplant and adult male liver transplant FDA accepted for review its NDA 12/6/12 Bristol-Myers Squibb Co. (New York) and

Tivantinib, given in combination with Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG), showed promising PFS, but that improvement didn't translate into statistical significance in the OS endpoint. (See BioWorld Today, Oct. 3, 2012.) Two months earlier, ArQule's Asian partner, Kyowa Hakko Kirin Co., stopped a Phase III NSCLC study, dubbed ATTENTION, due to concerns of interstitial lung disease. (See BioWorld Today, Aug. 30, 2012.) Tokyo-based Daiichi holds rights to co-develop tivantinb