NICE publishes draft guidelines recommending that Bristol Myers-Squibb provide more data on Opdivo’s effectiveness for treating classical Hodgkin lymphoma. The committee said its current position is to not recommend the immunotherapy as an option for patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin.
Cynata Therapeutics, the Australian stem cell and regenerative medicine firm, has obtained approval from the UK MHRA to conduct its Phase 1 clinical trial of CYP-001 in patients with steroid-resistant graft-versus-host disease (GvHD). CYP-001 is Cynata’s lead Cymerus mesenchymal stem cell MSC product.
A type of non-Hodgkin lymphoma, WM usually gets worse slowly over time and causes abnormal blood cells to grow within the bone marrow, lymph nodes, liver and spleen. Abnormal B-cells also overproduce proteins that can cause excess bleeding and problems with vision and the nervous system. Janssen-Cilag’s Imbruvica has become the first therapy to be
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) have adopted a positive opinion for Novartis’ capsules. This involves combination of panobinostat capsules with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and
Novartis has received approval from the FDA for Promacta to treat children aged six years and older with chronic immune thrombocytopenia (ITP). ITP is a rare blood disorder that affects as many as five in 100,000 children every year and is characterised by a low platelet count. The drug has been approved for children with
Roche have posted positive clinical trial Phase II results for lampalizumab when treating age-related macular degeneration (AMD). The clinical trial demonstrated that patients with the dry form of AMD had a 20% reduction in geographic atrophy after 18 months’ treatment.
Payer demand for value indicators that can guide compensation conclusions are prompting top pharmaceutical companies to increasingly request input into clinical development from their health economics department, according to a new study. While clinical data is fundamental in driving reimbursement decisions, companies that only evaluate finished clinical trial data to determine a product’s economic benefit
GlaxoSmithKline and Johnson & Johnson (J&J) announced yesterday that they have started Phase III clinical trials of their investigational rheumatoid arthritis (RA) treatment, sirukumab. Johnson & Johnson’s Janssen Biologics unit in Ireland and GlaxoSmithKline have begun a Phase III development programme for sirukumab (otherwise known as CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody. The
Dow Jones reported yesterday that Gilead Sciences have dropped the diuretic cicletanine after it failed to meet targets in a mid-stage clinical trial analysing the drug’s potential in high blood pressure. The Phase II, randomised, double-blind, placebo-controlled, multicenter, dose- ranging study was evaluating the efficacy, safety and tolerability of cicletanine in comparison to a placebo
The Association of the British Pharmaceutical Industry (ABPI) amended their guidelines on Phase I trials on Tuesday to echo alterations in the UK’s regulatory framework since the previous guidelines were issued in 2007. Since 2007, the association notes that “a considerable amount of what previously constituted guidance has now become requirement.” The updated guidelines are
