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

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

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

NeurOp is working with Emory to accelerated N-methyl D-aspartate, or NMDA, receptor research in the three-year collaboration...and six other countries under an expanded access program...co-promotion rights for Kineret (anakinra) to Savient Pharmaceuticals Inc., of Bridgewater, N.J. Under the agreement, Sobi will remain responsible for all commercial drug manufacturing, supply, safety and regulatory activities involving Kineret, which is indicated in the U.S

In a pipeline update, Momenta Pharmaceuticals Inc., of Cambridge, Mass., said that it is developing three biosimilar products under its collaboration with Baxter International Inc., of Deerfield, Ill. M923 and M834 are targeted to autoimmune and inflammatory conditions, and M511 is a monoclonal antibody in development for oncology...The company plans to submit an investigational new drug application in 2014 for M923 and may generate a license or milestone payment for M511 and M834 next year

Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA responded to its investigational new drug (IND) application for oral insulin, requesting a sub study in a controlled inpatient setting...for the treatment of active, mild-to-moderate ulcerative colitis...On Thursday, United's shares (NASDAQ:UTHR) gained $2.29, to close at $56.10

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

The FDA advised the firm to apply for fast-track designation when it submits its IND, which is expected to come in the fourth quarter of 2013...MorphoSys may sublicense the targets to third parties, and is eligible to receive license fees, milestones and royalties on any Ylanthia antibody developed by Heptares

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

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unit

According to a joint statement from the two companies the amendment was executed primarily to provide EpiCept with cost-effective operating capital while the merger closing process continues. (See BioWorld Today, Dec. 28, 2012...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents ages 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

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