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Sales of the uterine fibroid therapy, Esmya, sharply declined during the first half of 2018 at Hungary's specialty pharmaceuticals company, but an EU review of a potential association between the drug and liver injury has now been completed.
Otsuka's guadecitabine has missed co-primary endpoints in older treatment-naïve AML patients but it continues to be evaluated in relapsed and refractory patients, in a therapeutic area undergoing considerable innovation.
Positive top-line results from the Phase IIb DOVE study of Scynexis's SCY-078, and progress with a new intravenous formulation, suggest the US biotech's new triterpenoid could be the first of a new class of antifungal agents for serious infections.
Analysts generally were not surprised that Imbruvica plus R-CHOP did not provide a significant benefit versus R-CHOP alone in a hard-to-treat type of non-Hodgkin lymphoma. The failure leaves an opening for competitors, such as Celgene's Revlimid, which will soon have data in this indication.
Positive recommendations for the approval of CAR-T therapies Yescarta and Kymriah were delivered in Europe in June. Michael Elliott, Gilead Sciences' VP for medical affairs in Europe, spoke to Scrip about the Yescarta launch strategy and the long-term future of CAR-T.
Lilly reported positive results for Taltz in a second Phase III study in ankylosing spondylitis and plans to file for FDA approval this year, which would give the IL-17A inhibitor a label similar to its rival Cosentyx, for which Novartis is working hard to build, maintain and grow market share.
With Merck's Keytruda on top of the world and setting the standard for PD-1/L1 lung cancer data, Roche and Bristol defended the programs for their competing Tecentriq and Opdivo during ASCO investor events.
As results for KEYNOTE-042 are reported at ASCO, Merck's Roy Baynes says Keytruda plus chemotherapy is the standard of care in first-line non-small cell lung cancer, but Keytruda monotherapy is an option for those who don't tolerate chemo well and/or don't have very active disease.
An autologous CAR-T therapy in development by Janssen and Legend Biotech is expected to kick-off US clinical studies in the second half of 2018, adding to the race to apply the new technology to multiple myeloma.
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