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

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

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

18 to close at $1.94, with more than 31 million shares changing hands. (See BioWorld Today, Dec. 6, 2012...ProBioGen AG, of Berlin, said another undisclosed global pharma company licensed rights to its GlymaxX ADCC-enhancement technology...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 respiratory and other diseases based

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

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

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...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported that the FDA accepted for review a new drug application for lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, for the treatment of adults with Type II diabetes mellitis

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

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

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

AMRI, of Albany, N.Y., signed a license agreement with Chai Therapeutics LLC, an affiliate of Bessor Pharma LLC, of Framingham, Mass., to develop its tubulin inhibitor, ALB109564, which is in Phase I testing...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

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

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