DUBLIN – AC Immune SA's distinctive approach to addressing drug targets associated with Alzheimer's disease has secured more big pharma validation, in the form of a mammoth license agreement with Eli Lilly and Co. covering its preclinical portfolio of small-molecule tau aggregation inhibitors. Lausanne, Switzerland-based AC Immune is banking CHF80 million (US$80.6 million) up front, another CHF50 million from a loan-to-equity instrument and an expected CHF60 million in near-term milestones. It could also earn up to CHF1.7 billion more in development, regulatory and commercial milestones, as well as tiered low double-digit royalties on product sales. Read More
HONG KONG – Chinese drugmakers' stocks hit their worst slump since 2008 last week on reports of a government pilot program aimed at lowering generic drug prices. Read More
A somber Kevin Gorman was brutally honest with analysts Wednesday, advising them to remove Tourette syndrome (TS) from their Neurocrine Biosciences Inc. model after Ingrezza (valbenazine) missed the primary endpoint of change from baseline to week 12 in Yale Global Tic Severity Scale (YGTSS) score among children and adolescents with moderate to severe symptoms enrolled in the phase IIb T-Force GOLD study. Read More
NEW DELHI – With record domestic approvals, active engagement in semi-regulated markets and a growing footprint in regulated markets, the Indian biosimilars industry is poised to hit the $40 billion mark by 2030, according to a new industry analysis report. Read More
A single pivotal phase III trial of an enzyme engineered to treat a rare urea cycle disorder, arginase 1 deficiency (ARG1-D), could potentially support U.S. and European approvals of the therapy, according to Aeglea Biotherapeutics Inc. The Austin, Texas-based biotech expects to start dosing a small group of patients with the enzyme, its lead candidate pegzilarginase, during the second quarter of 2019 and to make top-line data available in the first quarter of 2021. Read More
HONG KONG – China's Bio-Thera Solutions Ltd. has launched the phase I trial of BAT-4306F, an antibody-dependent cellular cytotoxicity (ADCC)-enhanced monoclonal antibody (MAb) that seeks to treat relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma patients. Read More
Checkmate Pharmaceuticals Inc., of Cambridge, Mass., said it completed a $22 million financing led by a new investor, Decheng Capital. The proceeds will support ongoing clinical development of its lead product, CMP-001, in advanced melanoma and non-small-cell lung cancer refractory to prior anti-PD-1 therapy, along with expansion into additional solid tumor types. Read More
Q Biomed Inc., of New York, said it will work with Menlo Park, Calif.-based SRI International to provide formulation development, preclinical development and early clinical manufacturing of QBM-001, the company's preclinical program for autistic spectrum disorder drug development program for nonverbal or minimally verbal autistic children. Read More
In what could be the next step toward a 21st Century Cures approach to health care spending, Senate Health, Education, Labor and Pensions (HELP) Committee Chair Lamar Alexander (R-Tenn.) is tapping on think tanks, economists, state officials, patients and other stakeholders across the health care enterprise for suggestions on what Congress can do to rein in U.S. costs. Read More
Matinas Biopharma Holdings Inc., of Bedminster, N.J., appointed Christie M. Ballantyne, John J.P. Kastelein and Kevin C. Maki to its scientific advisory board. Read More
