31.05.2013 - Genmab's and GSK's CD20 antibody ofatumumab challenges Roches
glyco-optimised obinutuzumab as treatment for CCL patients.
According to data presented by the Danish-British partnership, a combination therapy of ofatuzumab (Arzerra) and chlorambucil significantly improved median progression-free survival of patients with chronic lymphocytic leukaemia (CLL). Patients treated with the combination lived 22.4 months on average without the disease worsening. That is 9.3 months more than in patients receiving the chemotherapeutic alone (13.1 months; Hazard Ratio 0.57; p<0.001).
Two weeks prior to that, Roche had also met the primary endpoint of a Phase III study demonstrating a 12 months PFS benefit (23 months vs 10.9 months, HR=0.14, 95% CI 0.09-0.21, p <.0001) of a combination of obinutuzumab + chlorambucil compared to chemotherapy alone.
According to Genmab, serious adverse events were in the expected range with 3% of serious infusion reactions. Although not being statistically significant at this point in time, Roche published data indicating a higher rate of first-contact infusion reactions than observed after injections of the company's blockbuster rituximab.CLL is the most common form of leukaemia in adults. At present, no curative therapy is available.
12.05.2015 US pharma is coming to European biotech to fill their pipeline. Pfizer is paying €77.5m for an option on Dutch AM-Pharma, while Juno Therapeutics acquired German biotech Stage Cell Therapeutics for around €72m.
26.05.2015 The Finnish Medicines Agency Fimea has joined the Dutch MEB in its stance on the interchangeability of biosimilars. The Fimea now sees physician-driven switching of biologics as unproblematic.
20.05.2015 The Scottish Government has announced it will double the amount of funds for rare diseases. The New Medicines Fund that was created last year for this purpose will be increased to £80m (€112m).
30.04.2015 The European Parliament has given the go-ahead on a new law limiting the use of harmful crop-based biofuel in the transport sector. The decision marks a breakthrough in the EU’s approach to biofuels.
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