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

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

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

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

The restricted stock units vest over three years, and each is subject to terms of the company's 2012 equity incentive plan...Seattle Genetics Inc., of Bothell, Wash., reported that Health Canada has approved for marketing Adcetris (brentuximab vedotin), to treat: Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates...No data demonstrated increased survival with Adcetris

Shire plc, of Dublin, Ireland, said it reached agreement in principle to resolve the previously disclosed civil investigation into Shire's U.S...sales and marketing practices relating to Adderall XR (mixed amphetamine salts), Vyvanse (lisdexamfetamine dimesylate) and Daytrana (methylphenidate transdermal system

The company brought patent infringement action in April 2010 against generic firm Watson Laboratories Inc., of Parsippany, N.Y., (now known as Actavis) after Watson applied to the FDA to market a generic version of Rapamune

Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it reacquired development and commercialization rights for apaziquone in the U.S., Europe and other territories pursuant to an agreed-upon restructuring of the firm's collaboration with Allergan Inc., of Irvine, Calif...Spectrum also agreed to conduct one additional Phase III study following its FDA consultation. (See BioWorld Today, Oct. 30, 2008, and April 6, 2012...Teva said it intends to book a noncash net charge of $109 million as a result

Endocyte expects to file an investigational new drug application by the end of 2013...The new facility will enable the firm to supply PLX cells to conduct additional trials in parallel with ongoing trials if it chooses

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema

SOHO Industri Pharmasi for the registration and commercialization of Caldolor (ibuprofen) injection, which is used to treat pain and fever in the hospital setting...Merck Serono, of Geneva, a division of Merck KGaA, and the Feinstein Institute for Medical Research, the research division of the North Shore-Long Island Jewish Health System in New York, said they will collaborate to develop antibodies for the treatment of systemic lupus erythematosus (SLE...The program will focus on the use of antibodies

to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor...In other news, Novartis said the FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia