Chelsea Therapeutics International Ltd., of Charlotte, N.C., dosed its first patient in Study 401, a trial of Northera (droxidopa) for neurogenic orthostatic hypotension in patients with primary autonomic failure, dopamine beta hydroxylase deficiency, and non-diabetic autonomic neuropathy.
Glycomimetics Inc., of Gaithersburg, Md., said it highlighted its glycomimetic drug candidate, E-selectin antagonist GMI-1271, during an oral presentation and poster session. GMI-1271 is currently in preclinical studies for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis.
Summit Corp. plc, of Oxford, UK, said the first Duchenne Muscular Dystrophy (DMD) patient has been enrolled and dosed in a Phase Ib clinical trial of the oral, small molecule utrophin modulator SMT C1100.
Despite being haunted by the progressive multifocal leukoencephalopathy (PML) specter raised by natalizumab, Takeda Pharmaceutical Co. Ltd.’s Entyvio got strong support Monday from two advisory committees that weren’t overly concerned by trials that missed some endpoints.
Gilead Sciences Inc.’s Sovaldi (sofosbuvir) fared better than some expected in the FDA approval made public late in the day Friday, when the agency gave its blessing to 400-mg tablets of the once-daily nucleotide analog polymerase inhibitor for chronic hepatitis C virus (HCV) as part of a combination antiviral treatment regimen.
NEW ORLEANS – Blood cancers are naturally a major area of interest for hematologists, which leads to shared interests with solid tumor researchers. And that’s what brought Julian Downward to his first annual meeting of the American Society of Hematology in several decades.
NEW ORLEANS – Data from much-anticipated studies were revealed at Sunday’s plenary session at the American Society of Hematology’s 55th annual meeting. One was the head-to-head comparison of Genentech Inc./Roche AG’s Gazyva (obinutuzumab/GA101) with Rituxan (rituximab, Biogen Idec.) for the treatment of chronic lymphocytic leukemia (CLL).
LONDON – Adaptimmune Ltd. released positive data from the ongoing open-label Phase I/II trial of its autologous T-cell immunotherapy in treating multiple myeloma, reporting a 77 percent complete response rate in the 20 patients treated to date, at 100 days post-infusion of the modified cells.
Proteostasis Therapeutics Inc. partnered with Biogen Idec to find new drug candidates based on inhibition of Usp14 in a deal worth upward of $200 million. The partnership will pair Proteostasis’ work in protein degradation with Biogen Idec’s expertise in neurodegenerative diseases.
The tone of the briefing document posted by the FDA for Wednesday’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting suggested sponsor Amylin Pharmaceutics LLC, a wholly owned subsidiary of Bristol-Myers Squibb Co. (BMS), may have a skeptical panel on its hands reviewing the biologics license application (BLA) for metreleptin (recombinant methionyl human leptin) in metabolic disorders associated with lipodystrophy.