In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

To date, Celltrion and Hospira have identified only two products from the alliance – Remsima, a biosimilar version of autoimmune drug Remicade (infliximab, Johnson & Johnson), which won approval as the first biosimilar monoclonal antibody last year in Korea, and a biosimilar version of breast cancer drug Herceptin (trastuzumab, Roche

Triple-negative breast cancer accounts for one-fifth of breast cancers, and there are no targeted therapeutic options

To date, Celltrion and Hospira have identified only two products from the alliance – Remsima, a biosimilar version of autoimmune drug Remicade (infliximab, Johnson & Johnson), which won approval as the first biosimilar monoclonal antibody last year in Korea, and a biosimilar version of breast cancer drug Herceptin (trastuzumab, Roche). (See BioWorld Today, April 19, 2013

Eddingpharm, of Hong Kong, entered a collaboration with GlaxoSmithKline plc (GSK), of London, whereby Eddingpharm will acquire from GSK the exclusive right in mainland China to import, market, promote, distribute and sell Tykerb (lapitinib), a treatment for advanced or metastatic breast cancer that was recently approved by the China State Food and Drug Administration

Pfizer Inc., of New York, said its palbociclib (PD-0332991), an oral and selective inhibitor of cyclin-dependent kinases 4 and 6, received breakthrough therapy designation by the FDA for the potential treatment of patients with breast cancer...letrozole alone as a first-line treatment in postmenopausal patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer

Eddingpharm, of Hong Kong, entered a collaboration with GlaxoSmithKline plc (GSK), of London, whereby Eddingpharm will acquire from GSK the exclusive right in mainland China to import, market, promote, distribute and sell Tykerb (lapitinib), a treatment for advanced or metastatic breast cancer that was recently approved by the China State Food and Drug Administration

DARA BioSciences Inc., of Raleigh, N.C., said it signed a deal with Prime Therapeutics Specialty Pharmacy LLC for distribution of its two lead products, Gelclair (oral bioadhesive gel) for patients with oral mucositis and Soltamax (tamoxifen citrate) oral solution to treat breast cancer patients

The company's market entry in Russia will be based on launching breast cancer treatment Halaven (eribulin), expected during the second quarter of this year

Acuvax Ltd., of Brisbane, Australia, will acquire Biolife Science Ltd., also of Brisbane, and seeks to generate up to $5 million for Phase II trials of Biolife's HER-Vaxx vaccine for breast cancer, a potential alternative to Herceptin (trastuzumab, Roche AG

Sunshine Biopharma Inc., of Montreal, said it started negotiations with several contract manufacturing organizations for the GMP manufacturing of 1 kg of Adva-27a, its drug in development for treating breast cancer that has become resistant to existing therapeutics

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the FDA approved Lymphoseek (technetium Tc 99 m tilmanocept) injection, a radioactive diagnostic imaging agent designed to help doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes

The drug gained approval for patients with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy

Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company focused on the development of oncologic agents for the treatment of metastatic breast cancer (MBC), non-small-cell lung cancer (NSCLC) and other cancers

The drug gained approval for patients with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy

Sunshine Biopharma Inc., of Montreal, said it completed seven in vitro studies, in which Adva-27a showed potent antitumor activity in every cell line tested, including multidrug-resistant breast cancer, multidrug-resistant uterine cancer and small-cell lung cancer

biOasis Technologies Inc., of Vancouver, British Columbia, said its Transcend-Herceptin Conjugate (BT2111) product (a conjugate of Roche AG's Herceptin [trastuzumab] and biOasis' brain delivery vector) reduced the number of metastatic human HER2-positive breast cancer tumors in the brains of test animals by 68 percent when compared to untreated control animals

Abraxane was first approved in 2005 for metastatic breast cancer

Cel-Sci Corp., of Vienna, Va., said its collaboration with Northeast Ohio Medical University produced an investigational breast cancer vaccine, which prevented and treated a HER2/neu-expressing tumor in a mouse model of the disease