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

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

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

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

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

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

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

GlaxoSmithKline plc, of London, said it submitted a marketing authorization application to the European Medicines Agency (EMA) for trametinib (ME) as a monotherapy and in combination with dabrafenib (BRAF) for the treatment of adults with unresectable or metastatic melanoma with a BRAFV600 mutation...Ipsen SA, of Paris, and Braintree Laboratories Inc., of Braintree, Mass., said that Eziclen/Izinova (BLI-800) completed the European decentralized registration procedure, giving member states 30 days

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