BEERSE, Belgium--(BUSINESS WIRE)-- Janssen-Cilag International NV (Janssen) announced today that The Committee for Medical Products for Human Use (CHMP) of The European Medicines Agency (EMA) has granted a positive opinion on two variations relating to the use of VELCADE.1 VELCADE is indicated for the treatment of multiple myeloma, a type of blood cancer. The first recommendation is for the use of VELCADE (bortezomib) as retreatment in adult patients who have previously responded to treatment with the same medicine.1 The positive opinion re-enforces the existing data supporting the use of VELCADE in this wider relapsedpatient population in the European Union. This is now included in the label and does not require an additional decision from the European Commission. Concurrently, the CHMP also announced a positive opinion recommending the approval of VELCADE as induction therapy in combination with dexamethasone (VD) or dexamethasone and thalidomide (VDT). This is for adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.1 This will now bereferred for approval to the European Commission. VELCADE was previously indicated for use in combination with melphalan and prednisone for the treatment of multiple myeloma in adult patients that are previously untreated but … Continue reading →

Thursday, June 27, 2013 A leading researcher into severe spinal cord injuries says trials for stem-cell therapy show groundbreaking results in helping immobile patients to walk again. After progress in a second round of tests using stem cells to regrow nerve fibers, the China Spinal Cord Injury Network, set up in Hong Kong, has applied for regulatory approval in the mainland for a third and final phase, which could start in the autumn. "This will convince the doctors of the world that they do not need to tell patients `you will never walk again,"' said US- based doctor Wise Young, the alliance's chief executive. "Hong Kong is going to be way ahead of all countries if the spinal cord injury trial turns out to be positive. He said 15 of 20 patients in Kunming who received umbilical cord blood cell transplants and intensive therapy were on average able to walk with minimal assistance seven years after suffering complete spinal cord injury. "It's the first time in human history that we can see the regeneration of the spinal cord," Young added. The treatment involves injecting umbilical cord blood mononuclear cells into patients' spines to help regenerate nerves, while lithium is used … Continue reading →

A leading researcher into severe spinal cord injuries on Wednesday said trials for stem-cell therapy showed groundbreaking results in giving immobile patients the ability to walk again. After progress in a second round of tests using stem cells to regrow nerve fibres, the China Spinal Cord Injury Network (ChinaSCINet) has applied for regulatory approval in China for a third and final phase, which it hopes to start in the autumn. "This will convince the doctors of the world that they do not need to tell patients 'you will never walk again'," US-based doctor Wise Young, chief executive officer of ChinaSCINet, told AFP. He said that 15 out of 20 patients in the Chinese city of Kunming, who received umbilical cord blood cell transplants and intensive walking therapy, were on average able to walk with minimal assistance seven years after complete spinal cord injury. "It's the first time in human history that we can see the regeneration of the spinal cord," Young said. The treatment involves injecting umbilical cord blood mononuclear cells into patients' damaged spines to help regenerate nerves, while lithium is used to promote the growth of the nerve fibres. Each component of the combination therapy will be tested … Continue reading →

Cell-based therapies are providing new hope for the treatment of sight-threatening inflammation. A review published in Progress in Retinal and Eye Research provides a comprehensive outline of current and future therapy for uveitis (also called intra-ocular inflammation). Uveitis is a group of conditions that account for a significant proportion of visual disability, characterised by progressive visual loss caused by retinal inflammation and oedema. The disorder is most common in people aged 2060, and the financial burden is as high as that of diabetic eye disease. Current treatment for uveitis includes the use of antibiotics, immunosuppressants, and oral steroids, however, they result in side-effects and none have been specifically approved for the treatment of uveitis (they have all been prescribed off label). Professor John Forrester from the Centre for Experimental Immunology, Lions Eye Institute, Perth says that there is a long list of side-effects caused by current treatment programs including renal failure, anaemia, and high blood pressure. In about 50 per cent of patients with uveitis, no infectious cause can be found and an immune-mediated or autoimmune cause is suspected. In these instances, pioneering cell-based therapies may provide the best hope for long-term treatment. Cell-based therapies can be divided into two … Continue reading →

SOUTH SAN FRANCISCO, CA--(Marketwired - Jun 28, 2013) - VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announced an update on the status of its strategic financing agreement with Autilion AG. Under the terms of the parties' April 2013 agreement, as amended, Autilion AG has committed to invest $36 million in VistaGen in consideration for 72 million shares of restricted VistaGen common stock, at a price of $0.50 per share, in a series of closings ending on or before September 30, 2013. The parties have amended their agreement, completed a first closing and scheduled additional closings to occur in July, August and September 2013. As noted previously, the self-placed strategic financing does not include warrants or investment banking fees. Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "I met with Autilion's team earlier this week, and we have been working closely with them since signing our agreement in April.We are confident and excited about completing this transformative financing.Building on the positive developments in our labs presented during the Annual Meetings of the Society of Toxicology and International Society of Stem Cell Research in March and … Continue reading →