This week, June 5 to 9, 2017, we had thoughts on the following: Novartis whets CAR-T appetites ahead of full data disclosure; Shire not gutted by Lialda generic; Quarterly dosing works for Teva’s migraine drug; Interim data prompt Nanobiotix to quintuple size of head and neck trial; Lack of stroke effect does not stop Sentinel clearance; FDA backs valve-in-valve use of Edwards’ Sapien; Investors light up Earlens with $118m; Glaxo gains ground against Gilead.
These snippets were previously published daily via twitter.
Novartis whets CAR-T appetites ahead of full data disclosure
8 June, 2017
Top-line interim data from Novartis’s keenly awaited Juliet trial of CTL019 did not fail to impress, with the pharma giant unveiling very encouraging response rates from the CAR-T project in lymphoma yesterday. The indication could represent a much larger patient population for the therapy than paediatric ALL, in which Novartis is already seeking US approval; it was also revealed this week that an FDA Advisory Committee will review the ALL application on July 12. However much remains to be learned when the full results of the lymphoma trial are presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland, on June 14. Deeper explanations for the difference between the enrolment rate and the infusion rate will be sought – of the 141 patients enrolled 43 discontinued before infusion, although in a press release Novartis sought to downplay any concerns about manufacturing by pointing out that only nine of these cases were down to the inability to make adequate doses of the CAR-T cells. And baseline patient comparisons will also be of interest, given that post-transplant patients are expected to have a much betterprognosis. 51% of Juliet patients had received stem cell transplants, it emerged; this compares with 20% of patients in Kite Pharma’s Zuma-1 study and 57% in Juno’s Transcend trial. These full data will allow CTL019 to be held up to these rivals’ efforts more rigorously.
Shire not gutted by Lialda generic
8 June, 2017
The FDA approval of Zydus Cadila’s generic version of Lialda is not the nightmare it once could have been for Read More
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