On the one hand, Protalix BioTherapeutics Inc.'s president and CEO, David Aviezer, sounded like he was really trying to roll with an FDA complete response letter (CRL) for lead compound taliglucerase alfa in Gaucher's disease that instantly sliced more than 20 percent off the company's stock price and added more costly months to the approval process. Read More
LONDON – TiGenix NV is merging with fellow cell therapy specialist Cellerix SA in an all-share deal valuing Cellerix at €58 million (US$79.7 million), creating a clear leader in the European regenerative medicine field, with two marketed products and a number of allogeneic adult stem cell therapies in clinical development. Read More
Getting a better biological handle on neurological diseases is definitely an unmet need. Diagnosing neurological diseases – and indeed, deciding whether a disease is neurological in the sense of having a physiological basis, or psychological, originating in the mind – remains a highly imprecise art at best. Read More
LONDON – An enzyme exclusive to Mycobacterium tuberculosis and related bacteria could provide a paradigm for discovery of new and specific antibiotics, researchers contend. Read More
Chelsea Therapeutics International Ltd., of Charlotte, N.C., completed its public offering of common stock. The company said that underwriters exercised their option to purchase approximately 1.3 million additional shares to cover overallotments, increasing net proceeds to $37.8 million. Chelsea intends to use the proceeds to fund its droxidopa programs, including commercialization and marketing activity for Northera (droxidopa), to fund its study of CH-4051 for the treatment of rheumatoid arthritis, to fund development of its other product candidates and for general corporate purposes. Read More
Ipsen SA, of Paris, and BioMérieux SA, of Marcy l'Etoile, France, said they will collaborate to leverage Ipsen's portfolio of compounds and BioMérieux's diagnostic tests and identify programs that would benefit from the co-development of a therapeutic and a companion diagnostic test, notably in the prevention and treatment of prostate and breast cancers, neuro-endocrine tumors and pituitary tumors. Read More
Vermillion Inc., of Austin, Texas, received U.S. Patent No. 7,867,719 titled, "Beta-2 microglobulin as a biomarker for peripheral artery disease." Vermillion also received a notice of allowance for a patent titled, "Biomarkers for breast cancer." Read More
Helix BioPharma Corp., of Aurora, Ontario, filed a clinical trial application with the Polish Ministry of Health for a planned Phase I/II study of lung cancer candidate L-DOS47, an immunoconjugate drug developed using the DOS47 technology. The open-label trial is designed to test the efficacy of the drug alone and in combination with chemotherapy or radiation therapy and will enroll patients with inoperable, locally advanced, recurrent or metastatic nonsquamous non-small-cell lung cancer. The multi-arm study will include about 30 to 50 patients in each treatment arm in order to reach the maximum-tolerated dose. Read More
Researchers from Emory University discovered there's a link between a specific peptide and its receptor to the development of post-traumatic stress disorder (PTSD) in traumatized women but not men. Read More