Gilead files for filgotinib in Japan; Alzheimer's flop forces some painful next steps at Neurotrope
→ Gilead has been right on the heels of its rival AbbVie with its JAK-inhibitor filgotinib. The company has now submitted an NDA for the drug to the Japanese Ministry of Health, Labor and Welfare for the treatment of adults with rheumatoid arthritis (RA). The submission is backed by data from the phase III FINCH trial, where “once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, to achieve low disease activity and remission and to inhibit structural damage for patients living with RA.”
→ After being rejected by the FDA 2 years ago — on the grounds of manufacturing issues — for its implanted diabetes drug/device ITCA 650, Intarcia Therapeutics disclosed that the FDA has accepted its resubmission of its NDA for ITCA 650 to treat type 2 diabetes mellitus, and set a PDUFA target action date of March 9, 2020.
→ After Neurotrope‘s phase II study of Bryostatin-1 failed to show any improvement over placebo early last month using the Severe Impairment Battery (SIB) total score at week 13 — resulting in shares cratering 78% with the company languishing in penny-stock territory — the New York-based company is now ominously planning to explore “strategic alternatives.”
→ Rare disease biotech Novelion Therapeutics shared that Nasdaq will indeed delist the company’s shares as of October 9. The decision comes after the stock exchange cited non-compliance with various listing requirements.
→ IGeneX — focused on the development of diagnostic testing for Lyme disease, TBRF, Bartonella and other tick-borne diseases — has won the approval of the Division of Laboratories of the Department of Health of the State of New York for the company’s Tick-Borne Relapsing Fever (TBRF) ImmunoBlots (IgM and IgG), making them immediately available to New York practitioners. IGeneX’s ImmunoBlots allow for the ability to detect antibodies to TBRF Borrelia species including, but not limited to, B. hermsii, B. miyamotoi, and B. turicatae — something that other tests have not been able to do.