As part of the agreement, the company pleaded guilty to a misdemeanor, entered a five-year corporate integrity agreement and agreed to dismiss its lawsuit challenging FDA regulations that criminalize truthful speech about approved drug uses. (See BioWorld Today, Oct. 24, 2011...Roche will provide R&D funding and scientific expertise to BioLamina

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

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The company intends to start clinical trials in the third quarter

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

In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San Diego facility and certain other cash needs...Cangene plans to advance the program in its pipeline with the goal of developing an immune therapeutic for Alzheimer's targeting the toxic form of amyloid beta that is believed to cause the disease...Exelixis Inc., of South San

The approval will expand Lupin's range of Suprax dosage forms available to treat approved indications in appropriate patients...Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine Hexyon/Hexacima, the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough