The drug's mechanism of action may overcome the challenges in pancreatic and other intractable cancers that have thwarted other comers, such as gemcitabine, Tarceva (erlotinib, Astellas Pharma Inc. and Roche AG) and a host of failed candidates

Astellas Pharma Europe BV (Meppel, the Netherlands) Vesomni Solifenacin + tamsulosin Benign prostatic hyperplasia The Dutch Medicines Evaluation Board granted marketing authorization 5/24/13 Astrazeneca plc (London) Naloxegol A peripherally acting mu-opioid receptor antagonist Opioid-induced constipation Results from two pivotal Phase III studies showed the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies 5/22/13 Baxter

Company (Location) Product Description Indication Status Date AUTOIMMUNE GW Pharmaceuticals plc (Porton Down, UK) Sativex Cannabinoid product Moderate to severe spasticity in multiple sclerosis Received commercial approval for Sativex in Italy 5/8/13 CANCER Aveo Pharmaceuticals Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Astellas no longer intends to submit an MAA and will not fund any

an alpha particle-emitting radioactive therapeutic agent Castration-resistant prostate cancer FDA approved it 5/16/13 Aveo Oncology Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced kidney cancer FDA committee voted 13-1 against approval of tivozanib 5/3/13 Genentech Inc. (South San Francisco; unit of Roche Group; Basel, Switzerland) and Astellas Pharma Inc. (Tokyo) Tarceva Erlotinib tablets Metastatic non-small-cell lung cancer FDA approved Tarceva

BMS is developing both. (See BioWorld Today, Sept. 23, 2011, and May 6, 2013.) CytomX could do worse than emulate the likes of Ambrx, which in April inked a cancer pact with Tokyo-based Astellas Pharma Inc., garnering $15 million up front and up to $285 million in potential near- and long-term research, development, regulatory and sales-based milestones for an undisclosed number of ADC targets

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

The trial, designated TIVO-1, was carried out in partnership with Astellas Pharma Inc., of Tokyo...A few weeks after the ODAC meeting AVEO's partner Astellas Pharma Inc., of Tokyo, said it didn't intend to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of RCC patients or fund any future trials in RCC under the firms' strategic collaboration inked in February 2011. (See BioWorld Today, May 28, 2013.) RBC Capital Markets LLC analyst

BMS is developing both. (See BioWorld Today, Sept. 23, 2011, and May 6, 2013.) CytomX could do worse than emulate the likes of Ambrx, which in April inked a cancer pact with Tokyo-based Astellas Pharma Inc., garnering $15 million up front and up to $285 million in potential near- and long-term research, development, regulatory and sales-based milestones for an undisclosed number of ADC targets

Astellas Pharma US Inc., of Northbrook, Ill., part of Astellas Pharma Inc., entered a distribution agreement with Tecnofarma International Ltd., of Buenos Ares, Argentina, to distribute enzalutamide (Xtandi in the U.S.) in Latin America, excluding Brazil, upon regulatory approvals in the various countries

and its partner Astellas Pharma Inc

AbbVie Inc., of Chicago, reported results from a Phase I study of ABT-199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and relapsed/refractory non-Hodgkin's lymphoma (NHL). The Phase I, open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the pharmacokinetics of ABT-199 in

and Astellas Pharma Inc

Amgen Inc., of Thousand Oaks, Calif., and Astellas Pharma Inc., of Tokyo, signed a strategic alliance agreement to develop and commercialize five Amgen pipeline medicines in the areas of cardiovascular disease, bone disease and cancer in Japan

AVEO Pharmaceuticals Inc., of Cambridge, Mass., said in an SEC filing that it was informed by partner Astellas Pharma Inc., of Tokyo, that Astellas no longer intends to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC...Medivation Inc., of San Francisco, said partner Astellas Pharma Inc., of Tokyo, submitted an application for marketing approval in Japan for enzalutamide in prostate

Astellas Pharma Europe BV, of Meppel, The Netherlands, a subsidiary of Astellas Pharma Inc., reported the Dutch Medicines Evaluation Board granted marketing authorization for Vesomni (solifenacin + tamsulosin) in the Netherlands

Ironically, last month GSK reported manufacturing delays, resulting in a stockout of the drug. (See BioWorld Today, Feb. 9, 2007, and Nov. 12, 2012.) Astellas Pharma Inc., of Tokyo, holds rights to Horizant in Japan and other Asian territories

Ltd. (Seoul, South Korea) ND Licensing agreement for the anti-angiogenic peptide ALM201 for clinical development and marketing in South Korea Shin Poong will make undisclosed up-front and milestone payments, along with royalties 4/30/13 Ambrx Inc. (San Diego) Astellas Pharma Inc. (Tokyo) $300 Oncology-focused discovery and development collaboration in antibody drug conjugates Ambrx will receive $15M up front, and up to $285M in research, development, regulatory and sales-based milestones for an

Astellas Pharma Inc. $300M Resolve Therapeutics LLC Takeda Pharmaceutical Co