As expected, Tokyo-based Daiichi Sankyo Co. Ltd. faced rough sledding in its review by the FDA's Oncologic Drugs Advisory Committee (ODAC) of quizartinib tablets for adults with relapsed or refractory acute myeloid leukemia (AML) that is FMS-like tyrosine kinase (FLT) 3-internal tandem duplication (ITD) positive, as detected by an FDA-approved test.
Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016.
Elevatebio Inc. CEO David Hallal told BioWorld that the five-member syndicate of investors behind his firm's whopper $150 million series A round "all have been on the other side of the table" in cell and gene therapy, and thus understand the potential value of building a portfolio of new companies in both areas by way of partnerships with academic researchers, medical centers and entrepreneurs.
Although some on Wall Street kept faith that the hobbled shares of Fibrogen Inc. will make up their losses as investors pick through the data, pundits meanwhile sought to unriddle the pooled phase III findings offered from the global program with roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity.
Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016.
Atara Biotherapeutics Inc.'s backers proved less than happy with the phase III delay for the T-cell immunotherapy tab-cel (tabelecleucel), but the company remained upbeat about prospects with the compound in patients with Epstein-Barr virus (EBV)-associated post-transplant lymphoproliferative disease (PTLD, or lymphomas that develop after a transplant).
Goldfinch Bio Inc. CEO Anthony Johnson told BioWorld that his company's deal with Gilead Sciences Inc. represents "a phenomenal opportunity, because this [kidney disease patient registry] will be the biggest of its type, definitely for the kidney but arguably across other disease areas as well."
What could become the first nonsurgical therapy for ptosis, or droopy eyelid, inched closer to an NDA submission with upbeat top-line phase III efficacy results from Study 202, Osmotica Pharmaceuticals plc's test of RVL (oxymetazoline hydrochloride ophthalmic solution 0.1%), supplemented by new long-term phase III safety data, known as Study 203.
