The FDA designated TG Therapeutics’ umbralisib with breakthrough status for the treatment of marginal zone lymphoma. Umbralisib had previously been designated an orphan drug.
The FDA has put a partial hold on an axalimogene filolisbac Phase III cervical cancer trial, until Advaxis provides additional chemistry, manufacturing and controls information. Under the hold, no new patients can be enrolled in the trial, but current patients can continue to be treated.
Pfizer is seeking approval for tafamidis to treat transthyretin amyloid cardiomyopathy (ATTR-CM). Patisiran and inotersen were approved in 2018 for the treatment of hereditary transthyretin familial amyloid polyneuropathy (hTTR-FAP). Both drugs are seeking to broaden their approval to other TTR amyloidosis diseases.
In a 9-day, 48 patient, Phase I trial, Eisai/Purdue’s lemborexant did not impair driving ability compared to placebo as measured by the standard deviation of lateral position in the morning after a bedtime dose.
In an 1,856 patient, Phase III trial 77.9% of patients treated with Lilly’s lasmiditan, who had one or more cardiovascular risk factors but had not developed cardiovascular disease suggesting that cardiovascular risk is not increased with lasmiditan.
In a 77-patient long term follow-up of the Phase II, open-label, Arades trial, the median time to PSA progression was 25.2 months with Bayer/Orion Pharma’s darolutamide, in men with progressive metastatic castration-resistant prostate cancer.
GeNeuro announced the generic name for GNbAC1 is temelimab.
In a 14-week, 834 patient, Phase III, dose ranging trial, patients treated with the highest dose of Daiichi Sankyo’s mirogabalin (30 mg) reduced a pain score compared to placebo in Asian patients with type 1 or 2 diabetes and diabetic peripheral neuropathic pain.
MacroGenics announced interim results from a 55 patient, Phase II, open label trial, where treatment with margetuximab plus pembrolizumab resulted in an overall response rate of 32.7% and progression-free survival of 4.7 months in patients with relapsed or refractory advanced HER2+ gastric carcinoma.
ChemoCentryx submitted an MAA for avacopan in Europe in early 2018, but then withdrew the application in early 2019. ChemoCentryx plans to submit and MAA and NDA for avacopan in 2020 based on data from the Phase III ADVOCATE trial that is expected to be available in late 2019. The ADVOCATE trial will compare avacopan to predinisone for the induction of remission in patients with ANCA-Associated Vasculitis that are also receiving cyclophosphamide, rituximab and azathioprine.
In a Phase III trial, treatment with Proteon Therapeutics’ vonapanitase did not reduce thrombosis occurrence or corrective procedures (primary fistula patency) compared to placebo in hemodialysis patients with a new arteriovenous fistula.
Anuria announced that in a Phase II trial, patients treated with voclosporin ophthalmic drops did not have less discomfort than patients treated with cyclosporine ophthalmic emulsion (Restasis) in patients with dry eye syndrome. In this trial, voclosporin ophthalmic drops did demonstrate better efficacy (secondary endpoints) as measured by Schirmer Tear Test/STT (an objective measure of tear production), and Fluorescein Corneal Staining/FCS (an objective measure of structural damage to the cornea).
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