In other news, Celgene said the European Commission amended the marketing authorization application for Revlimid (lenalidomide) so that it is now approved to treat patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate

The new facility will primarily handle the blister packaging of Eisai's investigational treatment lenvatinib which is used to treat thyroid cancer as well as other types of solid tumors...Teva will now have access to Microdose's technology including its multidose dry powder nebulizer device...Stifel acted as exclusive financial advisor to Microdose in the transaction

Celgene International Sarl, of Boudry, Switzerland, a unit of Celgene Corp., said the European Commission amended the marketing authorization application for Revlimid (lenalidomide) so that it is now approved to treat patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...Prior to the submission of an investigational new drug

The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous formulation of BMS' Orencia (abatacept), for the treatment of rheumatoid arthritis...Costs related to the reorganization are not expected to have a material effect on the group's finances

Elan continued to encourage shareholders not to tender shares in Royalty's current hostile bid for the biotech...According to Royalty, a "sufficient number of these ADSs" voted against Elan's proposed $1 billion cash acquisition of a royalty stream from South San Francisco-based Theravance Inc...related to its chronic obstructive pulmonary disease drug collaboration with London-based Glaxosmithkline plc, as well as Elan's proposed buyout of Vienna, Austria-based AOP Pharmaceuticals AG for €263.5

Astrazeneca will have first rights to the molecules discovered through the agreement and can choose further development in exchange for royalty payments to Cancer Research Technology...The second agreement allows Cancer Research UK scientists from the Paterson Institute to test a potential drug target against Astrazeneca's compound collection at Alderley Park to see if any could potentially work as a new drug

Xgeva previously gained approval in 2010 to prevent fractures when cancer has spread to the bone. (See BioWorld Today, Nov. 22, 2010...Madera has identified small-molecule compounds designed to increase the expression of apolipoprotein E (apoE), which has been shown to mediate beta-amyloid clearance from the brain and prevent its accumulation into the plaques that are characteristic of Alzheimer's

Aphios Corp., of Woburn, Mass., said it entered joint research collaboration and commercialization agreements with Vivacell Biotechnology Espana SL, of Cordoba, Spain, to develop therapeutics for multiple sclerosis and other neurodegenerative diseases of the central nervous system...That is in contrast to some other antibiotics, such as linezolid (Zyvox), which causes drug interactions when taken with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors

In other news, Biolinerx said it signed an out-licensing agreement with Jiagsu chia-tai Tianqing Pharmaceutical Co...It is being developed to help patients with epilepsy who require intermittent use of diazepam to manage bouts of acute and repetitive seizures

The venture, to be named ImmunoGenes-ABS Zrt, will provide funding for production capabilities for the ImmunoGenes programs known as Customized Antibody Solutions and Customized Transgenic Solutions...and certain other territories from Basel, Switzerland-based Novartis AG for $60 million up front, and additional payments of at least $75 million over the next several years, plus milestone payments prior to FDA approval

Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., entered into a development agreement with Welding GmbH & Co., of Hamburg, Germany, and SK Chemicals, of Seoul, South Korea, to develop and market an undisclosed drug candidate with potential U.S.-branded sales of approximately $500 million...Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against influenza disease

commercial rights to Mugard, a marketed product for the management of oral mucositis, from Access Pharmaceuticals Inc., of Dallas...Edge expects to enroll the first patient in a Phase I/II trial in the third quarter...Xenon plans to initially develop XEN701 for patients with chronic kidney disease who are intolerant of or who are poor responders to erythropoietin (Epo) therapy

Affymax will continue to trade under the symbol "AFFY...The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used

In addition to the research collaboration, which includes three cancer targets, Isis and AstraZeneca are developing two antisense drugs, ISIS-ARRx and ISIS-STAT3RX, discovered by Isis and licensed to AstraZeneca for the treatment of cancer. (See BioWorld Today, Dec. 12, 2012...The company expects to enter a third agreement (separation agreement) governing other terms of the firms' business relationship

Safyral is approved to prevent pregnancy in women who elect to use an oral contraceptive and to provide a daily dose of folate supplementation

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...Johnson & Johnson, of New Brunswick, N.J., said its Johnson & Johnson Innovation arm signed an agreement with the California Institute for Quantitative Biosciences (QB3) to allocate 5,000 square

Treatment was shown to significantly reverse the pulmonary hypertension associated with advanced stages of the disease and restore cardiovascular function...Under the terms, Genor licensed to Biocnd the South Asia, Southeast and Northeast Asia (except Greater China) and Russian rights to GB232, a biosimilar of Humira (adalimumab, AbbVie Inc.) and rest-of-world rights (except Greater China, Japan, the U.S. and Europe) to GB221 , a biosimilar of Herceptin (trastuzumab, Roche AG...The therapy is designed

according to the protocol, all patients were to have been treated with both bortezomib and lenalidomide prior to study entry...Based on the positive results GSK said it is planning to make regulatory submissions in Europe, the U.S., as well as other regions during the next few

to purchase all of the outstanding capital stock of ProFibrix, subject to the former's satisfactory review of the pending Phase III trial results with Fibrocaps, a dry powder topical formulation of fibrinogen and thrombin being developed to stop bleeding during surgery