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. Read More
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. Read More
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. Read More
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). Read More
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. Read More
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. Read More
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. Read More
Covagen AG, of Zurich, Switzerland, said it secured CHF42 million (US$47.1 million) in a tranched Series B financing with an option to obtain an additional CHF14 million to increase the round to CHF56 million. Read More
Coronado Biosciences Inc., of Burlington, Mass., submitted an investigational new drug application to the FDA to start a Phase II trial with Trichuris suis ova, or eggs of the porcine whipworm, for the treatment of moderate to severe chronic plaque psoriasis. Read More
Helsinn Group, of Lugano, Switzerland, and Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for review the submission of the new drug application for the investigational oral fixed-dose combination capsule of netupitant 300 mg + palonosetron 0.50 mg for prevention of acute and delayed chemotherapy-induced nausea and vomiting following highly and moderately emetogenic chemotherapy. Read More
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. Read More
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. Read More
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. Read More
