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

In other news, BioInvent said the first patient has been treated in a Phase II study of BI-505 for smoldering multiple myeloma, or asymptomatic myeloma...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

Net proceeds will be used to complete a Phase II Squalamine eye drop clinical trial for the wet form of age-related macular degeneration, to further the clinical development of the eye drops for the treatment of other neovascular ophthalmic disorders, to fund development of other pipeline molecules, and for general corporate purposes

Avilex Pharma ApS, of Copenhagen, Denmark, said it has received seed funding from Novo Seeds, the early stage financing arm of Novo A/S, which will be used to support the development of dimeric ligands targeting PDZ domains...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif., resulting in a stockout of the drug...The firms will aim to offer pharma and biotech companies a set of fully

PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen...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...The firms will aim to offer pharma and biotech companies a set of fully integrated nuclear receptor drug discovery capabilities by

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...DFH Pharma Inc., of Gaithersburg, Md., said it entered a research and product development agreement with Hetero Group, a research-based pharmaceutical group headquartered in Hyderabad, India, to develop

The manufacturing center will afford GSK the capabilities to eventually manufacture influenza vaccine based on a cell culture line...A pivotal program of Lu AE58054 is planned to start later this year, starting with a Phase III study in patients with mild to moderate Alzheimer's disease testing Lu AE58054 as an adjunct treatment to donepezil

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch...Medigene's partner, Nordic Pharma Group, of Paris, is planning to launch Veregen in the Czech Republic, Poland, Hungary and Slovakia this year, upon conclusion of the reimbursable price-fixing procedure by the responsible authority...The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with

Apricus Biosciences Inc., of San Diego, said it intends to cease financing its French subsidiaries, Finesco SAS, its French holding company, Scomedica SAS, its French sales company and NexMed Pharma SAS, its marketing company...In other news, law firm Bronstein, Gewirtz & Grossman LLC, of New York, said it is investigating claims on behalf of purchasers of Spectrum securities, after shares (NASDAQ:SPPI) fell as much as 38 percent on March 13 on news that the company slashed its revenue projections

The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with biotechs such as Transgene SA, of Illkirch, France, is designed to make the selection of new effective treatments to combat eight cancer pathologies easier...That news "shocked the Street," according to Roth Capital Partners analyst Joseph Pantginis...Investors took the news hard, sending shares of Spectrum (NASDAQ:SPPI) falling $4.64, or 37.3 percent, to close Wednesday at $7.79

Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is

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 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 (ecallantide) for hereditary angioedema and other angioedema indications in China, Hong Kong and Macau...Zealand Pharma

Abraxane was first approved in 2005 for metastatic breast cancer...The restricted stock units vest over three years, and each is subject to terms of the company's 2012 equity incentive plan

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

Toxicity experiments conducted to date revealed best-in-class potential with a greatly improved therapeutic index compared to other armed antibodies, due to an impressive safety profile, according to the company, which has opened a manufacturing facility in Nijmegen for the production of ADCs up to Phase III trials and early launches

to Firdapse, a drug in development for Lambert-Eaton myasthenic syndrome BioMarin agreed to invest $5M in Catalyst under a promissory note and note purchase agreement 11/1/12 Colby Pharmaceutical Co. (San Jose, Calif.) MannKind Corp. (Valencia, Calif.) $140 Deal for disease-specific antigen compounds and intra-lymph node injection (INLI) technologies from its MKC1106 cancer vaccine program Colby is paying up to $140M in up-front and milestone payments to MannKind, which also will receive tiered

A further nine patients are expected to be enrolled at three oncological centers in the U.S. Based on the results, the company will implement a clinical study aimed at evaluating the effects of Reparixin, an inhibitor of the CXCR1 receptor activated by chemokine interleukin 8, in oral monotherapy on cancer stem cells and on tumor microenvironment for the treatment of women with early stage breast cancer, before surgery...Galderma Pharma SA, of Lausanne, Switzerland, and Valeant Pharmaceuticals