Hopes that MEK inhibitor selumetinib might rise above an earlier failure to improve a rare eye cancer were dashed as the Astrazeneca plc-backed candidate fell short of improving progression-free survival during SELECT-1, a phase III trial targeting NSCLC.
The NIH has a serious problem, and it's not alone. Even as big datasets driving new threads of biomedical progress proliferate, a critical shortfall is showing up in another realm: "There is a desperate need for individuals who can develop creative approaches to bioinformatics problems." the NIH told members of the National Science and Technology Council last year.
Cleave Biosciences Inc. has completed a $37 million series B financing to support further development of CB-5083, its lead oncology candidate for hematological and solid tumor malignancies and discovery efforts related to its AAA ATPase platform over the next 18 months.
Given the blistering rate at which researchers of all stripes, academic and corporate, are accumulating data on the molecular nature of disease, applying those data in drug discovery efforts is a natural next step. But, even with plentiful data and computing power, multiple roadblocks to reducing the time, costs and productivity of discovery remain.
Interim results from a phase IIb trial testing a proprietary formulation of the anti-fungal drug itraconazole for the treatment of Gorlin syndrome reduced tumor burden by more than 30 percent in eight of 13 patients, Hedgepath Pharmaceuticals Inc. reported.
Global rights to Advaxis Inc.’s preclinical cancer immunotherapy, ADXS-NEO, are going to Amgen Inc. for a combined pledge of up to $540 million, giving Advaxis new cash to fuel its FDA fast-tracked phase III cervical cancer treatment, AXAL, while feeding Amgen’s ongoing interest in cancer vaccines, a pursuit that led to approval of the first FDA-approved oncolytic virus therapy, Imlygic (talimogene laherparepvec), last October.
Inspection issues and deficiencies at contract manufacturers for Adma Biologics Inc.'s primary immunodeficiency treatment RI-002 drew an FDA complete response letter for the company's biologics license application, sending Adma shares (NASDAQ:ADMA) down 17.3 percent to close at $6.49 on Monday.
Jazz Pharmaceuticals plc licensed global rights to several early stage blood cancer candidates from Pfenex Inc. in a deal that also included an option on an exclusive license for PF690, a biosimilar of Baxalta Inc.'s acute lymphoblastic leukemia (ALL) therapy, Oncaspar (pegaspargase), access to which could give Jazz wider reach in ALL.
The NIH has a serious problem, and it's not alone. Even as big datasets driving new threads of biomedical progress proliferate, a critical shortfall is showing up in another realm: "There is a desperate need for individuals who can develop creative approaches to bioinformatics problems." the NIH told members of the National Science and Technology Council last year.
