It appears that the biopharmaceutical industry's innovation engine is back on track and making up for its poor return on research investments last year when only 22 new molecular entities (NMEs) received the FDA's Center for Drug Evaluation and Research (CDER) green light, the fewest number for five years. (See BioWorld Insight, Dec. 27, 2016.) Read More
An off-the-shelf T-cell therapy for people with rituximab-refractory Epstein-Barr virus (EBV) flagged by the FDA for both orphan and breakthrough status is headed into dual phase III trials after the agency green-lighted its developer, Atara Biotherapeutics Inc., to make the move. Earlier data on the candidate, tabelecleucel, formerly known as ATA-129, suggests it might significantly improve the odds of survival for people who develop lymphomas and other lymphoproliferative disorders caused by EBV after solid organ or blood cell transplants. Read More
Although the number of complete response letters (CRLs) issued by the FDA to biopharmaceutical companies in 2017 dipped by 23 percent compared to the prior year, extensive planning and robust studies once again offered no foolproof promise of commercial glory. Read More
SHANGHAI – Nanjing-based Legend Biotechnology Corp. has partnered with Janssen Biotech Inc., a subsidiary of Johnson & Johnson, to develop in CAR-B38M, a promising chimeric antigen receptor T cell (CAR T) therapy for multiple myeloma that targets B-cell maturation antigen (BCMA). Read More
Lowering brain levels of urea and/or ammonia might be a viable new therapeutic target for Huntington's disease (HD), according to the findings of a New Zealand study reported in the Dec. 11, 2017, online edition of Proceedings of the National Academy of Sciences. Read More
Chimeric antigen receptor T-cell data from Bluebird Bio Inc. (and partner Celgene Corp.) stole the show recently at the American Society of Hematology (ASH) meeting, but the firm's results in sickle cell disease (SCD) may get more attention as time goes on. Not much is heard about the indication overall, CEO Nick Leschly acknowledged. Read More
Ignyta Inc., of San Diego, said the FDA cleared its IND application for RXDX-106, an oral immunomodulatory agent and TAM inhibitor designed to treat patients with solid tumors. Read More
Fervent Pharmaceuticals Inc., of Greenville, N.C., submitted an IND application to the FDA for FP-101, its lead drug candidate for treating menopause symptoms, especially hot flashes. Read More
The FDA said drugmakers have withdrawn more than 110 abbreviated new drug applications due to cessation of marketing, including heparin sodium for injection by Watson Labs Inc., a division that is now part of Teva Pharmaceuticals of Horsham, Pa. Read More
Saniona AB, of Copenhagen, entered a convertible notes funding agreement with Nice & Green S.A., a private Swiss financing firm, under which the latter committed to subscribe up to SEK72 million (US$8.7 million) in convertible notes in individual tranches of SEK6 million each over a 12-month period subject to prolongation by Saniona. Read More
Scientists have identified antibodies that stimulated bone marrow cells to differentiate into microglia-like cells and migrate to the brain, where they reduced the levels of amyloid plaque in mouse models of Alzheimer's disease. Read More
