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...Last month, Royalty Pharma made an $11-per-share takeover bid for Elan, an offer that values the firm at about $6.6 billion. (See BioWorld Today, Feb. 26, 2013

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

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

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

BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...The marketing authorization applies to all 27 European Union member states

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

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...Araxes Pharma LLC, of San Diego, said it inked an exclusive arrangement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop first-in-class therapeutics against a certain cancer target

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

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections...ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology

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) and Sutent (sunitinib, Pfizer Inc.), two other FDA-approved drugs to treat GIST...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections

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

Akela Pharma Inc., of Vancouver, British Columbia, said its wholly owned subsidiary, Formulation Technologies LLC, received a notice of default and that on Feb. 13 the subsidiary also received a notice of disposition of collateral on default from a secured creditor...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

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

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

The approval was based on a liver transplant study showing that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate for Zortress compared to standard tacrolimus at 12 months

patents relating to Exalgo to sell Actavis' 32-mg product beginning May 15, 2014...16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009

Breckenridge launched its abbreviated new drug application (ANDA) prior to patent expiration pursuant to a settlement of patent litigation with Osaka, Japan-based Takeda Pharmaceutical Co...and Takeda Pharmaceuticals North America Inc., which granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDA

Reddy expects to settle the offer on Feb. 13, to acquire the remaining shares of OctoPlus under the same terms during a post-closing acceptance period and to terminate the company's listing (Euronext Amsterdam:OCTO