Tecafarin recently completed a Phase III study showing it was safe and effective in patients with prosthetic heart valves in addition to patients with other conditions such as atrial fibrillation or venous thromboembolism, independent of CYP status...In addition to strengthening its balance sheet, Biovest said the move will support ongoing strategies to commercialize its BiovaxID personalized cancer vaccine, including facilitating ongoing partnering/licensing initiatives, as well as enhancing the

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy...The companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the U.K. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania...Under the agreement, Lundbeck will have the right to promote all formulations of Abilify currently marketed, sold or

to develop, manufacture and supply commercial quantities of Ofirmev (acetaminophen) injection in flexible plastic bags...According to the terms of an asset purchase agreement jointly executed by the parties, RXi will acquire substantially all of OPKO's RNAi-related assets, including an extensive intellectual property portfolio...Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company focused on the development of

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

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

Details Date Amarantus BioScience Inc. (Sunnyvale, Calif.) Convertible note financing N/A $1.4 Amarantus secured an additional $1.4M in financing commitments through an amendment of its initial $600,000 convertible note, issued in November 2012 to Dominion Capital, to $2M 2/1/13 BioLineRx Ltd. (Jerusalem) American depositary shares agreement 2.7ADS $8 BioLineRx agreed with OrbiMed Israel Partners Ltd...The date indicated refers to the BioWorld Today issue in which the news item can be found

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

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...Under the terms, Araxes will advance its program through Phase I to clinical proof of concept, after which Janssen will have sole responsibility for the continued development and worldwide commercialization of products arising under the agreement

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

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

Defibrotide will continue to be available to patients under a named patient program...The goal is to modulate the half-life of the therapy to increase efficacy of treatment

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

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