A new therapy for certain adults with relapsed or refractory acute myeloid leukemia (AML), developed by Celgene Corp. and Agios Pharmaceuticals Inc., has won earlier-than-expected FDA approval following a priority review. Read More
A look at the FDA's briefing document for Wednesday's Arthritis Advisory Committee (AAC) meeting suggests the other shoe could drop on Janssen Biotech Inc.'s sirukumab. Read More
Homology Medicines Inc. CEO Arthur Tzianabos told BioWorld that the new $83.5 million in series B money should let the firm "move our lead program all the way through a phase I/II proof-of-concept trial" while edging toward the clinic with the AMEnDR (AAV-Mediated Editing by Direct Homologous Recombination) platform at the same time. Read More
Milestone Pharmaceuticals Inc. collected its biggest raise to date, completing a $55 million series C led by Novo Holdings A/S that included new investors Forbion Capital Partners and funds managed by Tekla Capital Management. Read More
Genetic information firm Invitae Corp. plans to acquire both Good Start Genetics Inc., a molecular diagnostic company for preimplantation and carrier testing of inherited diseases, and Combimatrix Corp., a prenatal and pediatric diagnostic company, putting itself at the front of the family genetics space. Read More
HONG KONG – To speed up biopharmaceutical research on fighting superbugs, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently awarded grants to a number of biopharma firms, among them a 3-year-old startup aptly named Bugworks Research India Pvt. Ltd., which received $2.6 million. Read More
The FDA finalized a 2013 draft guidance on developing new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need. Read More
Innoviva Inc., of Brisbane, Calif., said it plans to offer $175 million of convertible senior notes due in 2025 in a private placement. The purchasers will also have a 30-day option to purchase up to an additional $17.5 million of the notes. Read More
Incyte Corp., of Wilmington, Del., reported second-quarter sales of JAK inhibitor Jakafi (ruxolitinib) totaling $276 million, compared to $208 million for the same period in 2016. Read More
