The application requests approval to expand the indication beyond the treatment of iron deficiency anemia in adults with chronic kidney disease to also include adults with iron deficiency anemia who have failed or could not take oral iron treatment...The three-year alliance, aiming to develop a drug pipeline targeting cancer metabolism, has been expanded to run to early 2015, adding the possibility of at least two new projects being selected by CRT

Funds will be used to advance development programs across Bionomics' pipeline, including BNC375, Bionomics' drug candidate for the treatment of Alzheimer's disease and other conditions where memory is significantly compromised and Bionomics' cancer stem cell directed drug candidate BNC101...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the

The agreement gives miRagen rights to a discovery made in the course of the collaboration...AstraZeneca gained the right to develop and commercialize alpha4beta2 NNR modulators licensed from Targacept, including AZD1446, in any therapeutic area...The company is planning to begin clinical trials in ischemic stroke and peripheral vascular diseases this year

Janssen said it is evaluating the letter and will respond to the agency's questions

materials to support ongoing commercialization of Brinavess, and oral API is expected to be sufficient for clinical trials...The initial percentage to be paid out directly to shareholders is 20 percent of those royalties. (See BioWorld Today, Feb. 25, 2013

Iroko Pharmaceuticals LLC, of Philadelphia, said the FDA accepted for review the new drug application (NDA) for lower-dose submicron diclofenac, a nonsteroidal anti-inflammatory drug, with a proposed indication of treatment of mild to moderate acute pain in adults...Relmada Therapeutics Inc., of Blue Bell, Pa., said an application for a clinical trial authorization (CTA) that was submitted with the UK's Medicine and Health Regulatory Agency (MHRA) to conduct a Phase I pharmacokinetic study with the

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities...Actavis said it may be a first applicant to file an ANDA for the generic version of Fortesta and, should its ANDA be approved, may be entitled to 180 days of generic

Separately, Adventrx said it plans to develop ANX-188 in complications of arterial disease, initially as an adjunct to thrombolytics in acute limb ischemia, a complication of peripheral arterial disease...Allergan intends to effect a short-form merger of Groundhog into MAP under Delaware law, with MAP becoming a wholly owned subsidiary of Allergan...The all-stock transaction plans to combine BioSante's cash, assets and licensing revenues with ANI's product portfolio, with the new company named ANI

The marketing authorization applies to all 27 European Union member states...A Phase I trial is expected to start this year in primary amyloidosis patients...TikoMed's product is designed to enhance the outcome of the treatment by improving the survival of transplanted cells by inhibiting a destructive immunological reaction and through stimulation of growth factors

CSL Behring, of King of Prussia, Pa., said the FDA approved an expansion of the indication for Corifact (Factor XIII concentrate [human]) to include the perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency...Reddy's and OctoPlus will jointly request NYSE Euronext Amsterdam to terminate the listing and trading of OctoPlus shares as soon as possible...Meda AB, of Goteborg, Sweden, said Acnex (clindamycin/tretinoin) received registration

Novo Nordisk A/S, of Bagsvaerd, Denmark, said its Norditropin (somatropin [rDNA origin]) 15-mg dose received a label update, allowing it to be left at room temperature after initial use for up to 21 days...Ltd., of Tokyo, said it submitted an application for the approval of the manufacture and marketing of oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine and tipiracil hydrochloride) to Japanese regulators for use in unresectable, advanced, recurrent colorectal cancer

Milo is developing therapies to treat muscular dystrophy by increasing muscle strength or decreasing the rate of muscle atrophy...The company expects to submit an investigational new drug application for Adva-27a, an irreversible stoichiometric inhibitor of topoisomerase II...The firm said it aims to enter clinical trials with its first biosimilar product within the next year and launch onto the marketplace by 2017

Ltd., of Osaka, Japan, said the FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause

That investment is intended to allow Bone Therapeutics to manufacture lead product Preob, an autologous bone cell therapy product in Phase III testing for osteonecrosis...Viropro Inc., of Washington, and Oncobiologics Inc., of Cranbury, N.J., signed a biosimilar collaboration agreement giving Viropro the rights to manufacture six generic versions of Humira (adalimumab, Abbott), Rituxan (rituximab, Biogen Idec Inc./Genentech Inc.), Avastin (bevacizumab, Genentech Inc.), Herceptin (trastuzumab

The FDA expanded the approved use of Stivarga (regorafenib), developed by Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., part of Bayer AG, to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments...With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or is metastatic and no longer responding to Gleevec (imatinib, Novartis AG

as a first-line agent or concomitantly with other topical ophthalmic drugs in open-angle glaucoma or ocular hypertension...Sucampo's wholly owned subsidiary, Sucampo Pharma Americas Inc., licensed the commercialization rights to Rescula, a BK channel activator, from R-Tech Ueno in 2009...As part of the transaction, Eisai transferred the new drug application for Targretin to Valeant, which assumed responsibility for pursuing the product's regulatory approval in the U.S. Eisai retained its rights to

Chelsea also plans to initiate a clinical trial in the fourth quarter, given the potential need to verify Northera's durability of effect in a postmarketing study...18 to close at $1.94, with more than 31 million shares changing hands. (See BioWorld Today, Dec. 6, 2012...Proteologics Ltd., of Rehovot, Israel, and Newcastle Innovation Ltd., the technology transfer company of the University of Newcastle, Australia, entered an exclusive license agreement to develop and commercialize therapeutics for

Ltd., of Seoul, South Korea, entered an agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates...and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritis

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases