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

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

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

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

Celgene expects Revlimid to be available to patients late in the second quarter of 2013...Teva opted to make a one-time payment of $880,000 in lieu of future payments

The complaint alleges that Daiichi Sankyo pays female sales employees less than male employees for performing the same work, promotes or advances female sales employees at a slower rate than male sales employees, treats pregnant employees and working mothers of young children adversely compared to other employees and subjects women to other discriminatory terms and conditions of employment

That drug is designed to treat acute myeloid leukemia, with potential applications in other hematological and solid tumors...Tranzyme Inc., of Research Triangle Park, N.C., said its board decided to explore and evaluate strategic alternatives, including the possibility of a merger, sale or other form of business combination, or other transaction to maximize value to its stockholders

As part of the settlement, Shire will make a one-time cash payment to Impax of $48 million, which was recorded as a liability on Dec. 31, 2012...Inc., of Woodcliff Lake, N.J., over an abbreviated new drug application filed by Anchen for a generic version of Amitiza (lubiprostone) oral capsules claiming infringement of six patents due to expire between 2020 and 2027...Taro Pharmaceutical Industries Ltd., of Yakum, Israel, and Sun Pharmaceutical Industries Ltd., of Mumbai, India, agreed to terminate

to purchase up to 1.5 million shares, or about 0.77 percent, of outstanding Alexion common stock at $90.50 per share...The companies partnered last year in a potential $200 million deal giving Avanir worldwide rights to AVP-786 and other deuterium-modified dextromethorphan compounds. (See BioWorld Today, March 1, 2012...Dyax Corp., of Burlington, Mass., and CVie Therapeutics, of Hong Kong, a subsidiary of Lee's Pharmaceutical Holdings Ltd., entered a deal to develop and commercialize Dyax's Kalbitor

The CRADA was initiated to complement ongoing R&D work funded previously by a Department of Defense grant to broaden the safety profile of perfluorocarbon-based emulsions to treat traumatic brain injury...In addition to the biochemical effects, VS-5584 also exhibited broad antitumor efficacy, including tumor regression, across multiple human tumor models

Ltd., of South Korea, so that, upon successful completion of the merger, the combined firm will re-acquire full rights to voclosporin for autoimmune indications including lupus, and transplantation in the U.S., Europe and other regions of the world outside of Canada, Israel, South Africa, China, Taiwan and Hong Kong...Protalix BioTherapeutics Inc., of Carmiel, Israel, said it engaged Citigroup to assist it in reviewing product partnering, technology sharing and other strategic alternatives...In

Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space...Those additions allow Janssen Labs to accommodate more than double the number of companies as when it launched in late 2011 as a 30,000

Aduro previously had licensed rights to two GVAX vaccines – GVAX Pancreas and GVAX Prostate – for use in combination with its Listeria-based vaccines...Under the terms, Aduro paid BioSante $1 million up front and has committed to additional milestone and royalty payments. (See BioWorld Today, July 1, 2009...BGI-Shenzhen, of Shenzhen, China, said it extended its all-cash tender offer to purchase all outstanding shares of Complete Genomics Inc., of Mountain View, Calif