Nice requests more Opdivo data

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.

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Panobinostat Recommended by CHMP for EU Approval to Treat Multiple Myeloma

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

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Health Economics Increasingly Inputs into Clinical Development

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

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J&J and GlaxoSmithKline’s Sirukumab Phase III Trials Begin

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

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Gilead Discontinues Development of Cicletanine

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

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ABPI Publish Updated Phase I Clinical Trial Guidelines

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

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