CEO Daniel Gold told BioWorld Today that MEI Pharma Inc. will fiddle with dosing and schedules in a new phase II study with pracinostat for myelodysplastic syndromes (MDS) as Helsinn Group starts a phase III trial testing the histone deacetylase (HDAC) inhibitor against acute myeloid leukemia (AML) under the terms of a deal worth up to $464 million.
A "higher cut-point of PD-L1 expression" is probably necessary for a PD-1 monotherapy to work relative to chemotherapy in first-line non-small-cell lung cancer, medical oncologist Matthew Hellman, of Memorial Sloan Kettering Cancer Center, told BioWorld Today.
With Eylea (aflibercept) for wet age-related macular degeneration (AMD) ringing up global sales of $1.32 billion in the second quarter, handily above the $1.26 billion consensus estimate, Regeneron Pharmaceuticals Inc. fielded questions from analysts about the phase II effort testing the compound in AMD when combined with REGN2176-3, or rinucumab, a PDGF receptor-beta antibody.
Edicts by the Federal Trade Commission (FTC) on Teva Pharmaceutical Industries Ltd.'s takeover of Actavis plc meant a windfall for Mayne Pharma Ltd., President Stefan Cross told BioWorld Today. "It's put us in another league," he said. "All of a sudden we have a profile in the U.S.," where he leads operations.
In the midst of what CEO Aya Jakobovits told BioWorld Today is “growth spree,” Adicet Bio Inc. bagged a $25 million up-front, five-year deal with Regeneron Pharmaceuticals Inc. to come up with off-the-shelf immune cell therapies that could attack solid tumors as well as blood cancers.
Early surprise phase III news from Biogen Inc. and Ionis Pharmaceuticals Inc. with nusinersen – which led to $75 million more in the latter's bank account – cranked up speculation regarding would-be rival Avexis Inc.'s AVXS-101 for spinal muscular atrophy (SMA).
Seres Therapeutics Inc.'s stock-joltingly failed phase II study with SER-109 was not the first or only placebo-controlled microbiome trial against recurrent Clostridium difficile infection (CDI), and better (currently embargoed) news will roll out during scientific sessions this fall from Rebiotix Inc., with RBX2660, CEO Lee Jones told BioWorld Today.
Figuring out which anaplastic lymphoma kinase inhibitor to use first in ALK-positive NSCLC, and handicapping the prospects for those coming through pipelines, has turned into a major challenge for oncologists, especially as resistance grows to New York-based Pfizer Inc.'s Xalkori (crizotinib), approved in August 2011 as a first-line treatment.
A site investigator in the failed phase III study by Taurx Therapeutics Ltd. told BioWorld Today that Alzheimer's disease (AD) "absolutely" will best be attacked by a combination approach, despite the finding that tau aggregation blocker LMTX when used along with the standard, "modestly" beneficial AD drugs "doesn't add any value."
